> Prof. Michael Hoffman from Toronto put me on to the Canadian Patent Database, where you can find that Novo did file a patent there for semaglutide. . .but the last time they paid the annual maintenance fee on it was 2018!
> You can even find a letter where their lawyers send a refund request for the 2017 maintenance fee ($250) because Novo apparently wanted some more time to see if they wanted to pay it.
> On the same date in 2019, the office sent a letter saying that “The fee payable to maintain the rights accorded by the above patent was not received by the prescribed due date. . .”
> By that time it was $450 with the late fee added, but that was apparently too much for Novo. They had a one year grace period to make it up, and apparently never did, so their patent lapsed in Canada. And as the Canadian authorities remind them, “Once a patent has lapsed it cannot be revived”.
Impressive failure for "the second-largest semaglutide market in the world."
I always wonder-in this case of such an epic company fuck up, does anyone ever get fired? Or is responsibility so diffuse that nobody is ultimately responsible?
Pharma companies are really nothing more than holders of time-limited, expensive, exclusive IP. The number one priority should be to maintain those protections as long as possible. How could any patent be allowed to lapse, even if there was limited commercial value, let alone, a blockbuster drug making billions?
Typically when people get fired for something like this they are just the scapegoat.
A failure like this isn't just one dude forgetting, its a system failure where policies and checks failed. If it is solely up to one person that is a failure in and of itself.
Just FYI, this isn't "by Science", it's by Derek Lowe, this is his blog, which is hosted on Science>Commentary>Blogs. In its description, Lowe says it is "editorially independent".
> An early instance of this sort of query was when Michael McLay publicly asked, in 1994, what would happen to the Python language if Guido van Rossum were to be hit by a bus.
I wasn’t casting aspersions on NN, but jumping off from the allusion that was made by the user who I replied to.
I don’t know what kind of sequence of events could lead to this outcome at NN, but perhaps they were hoist by their own petard. I’m reminded of the “money on the ground” joke involving two economists, which is semi-famous in these parts.
To wit:
> Economist 1: Look, there’s $20 on the ground!
> Economist 2: No there isn’t. If there were, someone would have picked it up already.
Perhaps the folks at NN are so busy picking up (billions of) dollars that they neglect the dimes on the ground that it would cost to comply with these seemingly trivial, even menial functional requirements of keeping their money printer running.
I’m honestly as befuddled by this brouhaha as anyone. This is a monumental failure of multiple entire business units to perform the core competencies of their jobs. That said, I could honestly believe that the number of people whose job it is (or perhaps was) to worry about the patent expiry at all, let alone be aware of the repeated communiques from the Canadian patent office, is quite low. I would further believe that the accountability dodging has only just begun behind closed doors, if the internal game of megacorporate musical chairs hasn’t already concluded well before this news broke and reached the shores of HN.
Even at large corps, it's fairly common to outsource IP work to law firms that specialize in IP - and if you're Danish, it might make sense to outsource to a Danish law firm that has its own worldwide IP contacts (rather than getting your own worldwide branch offices to handle local IP laws everywhere). One of said contacts might then pawn off the work onto a junior, who then has their assistant handle all communiques from CIPO. Said assistant could then entirely drop the ball.
I've zero idea about anything specific to Novo Nordisk, but have enough exposure to IP in Canada to envision the above happening in other cases.
> Or is responsibility so diffuse that nobody is ultimately responsible
It doesn't take a very large company for this to happen. I've seen it in a sub 50 person company. There is a task to be done but no one can do it because everyone involved is waiting for someone else to do something. It's like a Mexican standoff.
after working in many companies for decades I can guarantee that the person responsible is some middle manager, who will just blame one of her/his workers who had that piece of work "deprioritised" to instead focus on the styling of a spreadsheet. The paper trail will point to the manager, who will just claim it was allocated to a problem character.
The cartharsis comes in knowing that them firing the innocent just keeps them repeating the mistake.
If you're going to go for a two year supply, it's probably better to just risk shipping it. You're not going to come home with that much without it getting confiscated, and you're way more likely to be searched individually than a typical package is.
> With de minimis for US-bound packages suspended I suspect way more packages are inspected than used to be
But a smaller fraction.
If you’re paranoid, route it via the UAE. All my European and Indian shippers are doing that for tariff-free pricing. (Personal stuff. I’ll pay a customs duty if I get it, of course.)
At least for wine, furniture, cheese, olive oil, art, kitchen equipment and medicine, at least from Italy and Germany and India and Taiwan, in the last six months, allegedly.
Not an American but there’s only very limited circumstances you can travel across the border home to the USA with foreign prescription drugs, right? And this scenario wouldn’t cover it. Unless you just meant they won’t get caught or maybe not fined or confiscated in practice? :)
That's mainly for visitors. If you're a US resident, you can't just buy medicines abroad, unless of course we are talking about the "they won’t get caught" scenario.
US residents can buy medicines abroad the FDA link says personal importation is allowed as long as the medicines are FDA approved and are not being imported for commercial purposes. Now in the context of the original post maybe generic versions of Ozempic won't technically be FDA approved yet if the company that produces it has to wait for the US patent to expire.
While I'm all for saving costs, I would be shocked if mixing your own inject-able medicine either weekly (with the chance of making a mistake in dosage or sterility) or too such a high degree of sterility that you can confidentally store several doses is not worth the $200 return flight every two years. Maybe I'm overestimating the risks but it still seems like a small saving for it.
Realistically the cost of semiglutide in generic form means you could fly return every 90 days (personal import restriction for perscription meds) and still save $1000 every 3 months (3x$500 monthly - return flight - generic cost).
Its remarkably straightforward. Not fool-proof, but easy. Bacteriostatic water, single use needles/syringes, and self healing injection port vials makes it simple to maintain sterility throughout the process.
Multiple doses can be mixed and stored in the fridge for 4-6 weeks.
it's extremely common. everyone i know that's on a glp-1 does it this way. that way you can buy it in bulk for a discount. i buy mine roughly 35 weeks worth of doses at a time.
I guess you get more shelf life, but it's an injectable drug.
You probably have to disolve it in very clean water in a very clean container. Do you have to match the salinity and pH with the proprties of the blood? How much time must you stir it to ensure it's completely disolved? Do you have to add something to increase/reduce viscosity? Some alcohol in case there are a few bacterias or improve solubility? How long does the small homemade batch last in the fridge?
IIUC there is another version in pills, they may have a longer shelf life, or not. But ask a medical doctor before taking a ramdom medicine.
Bacteriostatic water is widely available and you hydrate it in the container it comes in. Its pretty easy. I promise you you probably know someone on a glp-1 that is already doing this.
So cocaine from the south, ozempic from the north, fetanyl from the west and the meth is homegrown. So USA just need some powder from europe to close the circle.
I bet many Americans would travel to Canada to buy it there
Why travel? There are thousands of ads on TV, radio, and the internet each day for Canadian pharmacies that promise to ship whatever you need to the U.S.
I have an acquaintance working big law. They said the billing was "more offensive thank you could possibly imagine" ... but they took the money of course.
To be honest, given the efficiency of the drug and the huge benefit it could be to society, I feel like if I had been the employee in charge of filing patents I would've more than ready to lose my job in exchange for low cost general availability in the US via (illegal maybe, whatever) cross-border market. It's a nice loop hole and a great thing that once the delay expired they can't file ever again.
One's got to find ways to feel like the good guy when working for Big Pharma . That's probably not what happened but it's nice imagining it.
AIUI, because they let the patent expire, the drug was not subject to price regulation by the government. So they could charge whatever.
And during most of that time, they were still protected by 'data exclusivity' which means that any generic producer could not get approved without doing their own clinical trials, until 8 years had passed.
So they gave up some period of exclusivity in return for being able to charge a higher price when they still had a monopoly.
The price in Canada is ~$175 USD month for name brand Ozempic where I am with no coupons, or other discounts. I see prices in the US around $800+/month.
That is significantly cheaper than the US, and cheaper than other GLP-1 class drugs up here, arguably reasonable. Is the supposition that they would have been forced to charge even less? If so, why are their competitors who kept their patents not charging more?
Counterpoint: Mounjaro/Tirzepatide did keep their patent protection. They are able to, and do, charge significantly more.
That doesn't figure into the pricing strategy or giving away patent protection in Canada in 2018 as far as I can tell?
Compounding isn't allowed in Canada, currently, so I assume you are talking about the US? Compounding Ozempic in the US wasn't a thing in 2018 when this patent was released in Canada, so not sure what one has to do with the other.
What are you getting at in reference to the argument that the patent was released intentionally in order to charge a higher price?
Most of what time? The patent just expired a few months ago. Generics are now ramping up because the patent expired, not because of some hypothetical eight year clinical trials. And for that matter, generics of existing ingredients and dosages do not have to repeat clinical trials anyways, which is one of the big reasons generics are a lot less expensive.
This hypothesis seems retconned and completely at odds with the actual facts. Not least that there has been absolutely nothing exceptional about the pricing of their product in Canada, which has always been one of the cheaper pricings worldwide.
In Brazil it will expire in July 2026. It's pretty relevant as it's kinda already announced they will put the generics on the public health care (SUS) for free... Which is big deal as an Ozempic shot costs almost the same as the minimum wage.
This year they already did an analysis to include Ozempic, but it was denied, probably because of the cost difference...
But they were trying on justice to extend the patent...
being free means taxpayers will pay. and being on the public system means it will be prescribed only for health risk, just like plastic surgery already is. you don't see people getting nose jobs just because.
> Interviewer at Endpoints: You plan to potentially launch a generic GLP-1 in Canada and Brazil in 2026.
Looking at the original interview on Endpoints, Sandoz CEO Richard Saynor says this about Brazil:
In Brazil, the biggest prescribers are dentists. Everyone says, “Why dentists?” They do aesthetic work, and then you have your Botox, and then you want a bikini body. It’s behaving like an OTC consumer brand. Imagine selling this, rather than $300, at $50. Anybody over the age of 40 in Brazil will probably want to be on that.
But he doesn't explain how they got around the patents. Another comment on HN says they expire in July 2026, but can anyone explain why the patents expire so soon in Brazil?
I think that loophole has closed. If I recall correctly, compounding pharmacies were only allowed to do that as the US gov put the drug on a special list due to shortages. I believe they have removed it from this list (or will do shortly) and that pipeline will stop.
I thought I had a decent handle on patent law, but maybe I'm missing something here.
Yes, the patent won't be valid for Canada, but you can't import a product into the US which would infringe on a US patent.
So, though there may be a small amount that would slip through the cracks, it isn't as if anyone in the US can now manufacture Semaglutide and distribute it.
Canada is such a small market, that many companies don't bother. Though, for the cost, it seems ridiculous a company as big as Novo didn't pay the $500...that may even have been in Canadian dollars. :)
Don't worry about the law think about the practical impact.
It's now completely legal to ignore the patent in Canada so the price in Canada will plummet.
Canadian pharmacies can legally sell it and Americans (and all other foreigners for that matter) traveling there can legally buy it.
Unlike the criminal law, Novo nordisk would have to go after every single person individually and make the case that they are infringing the American patent. This is all without the help of the police or customs, as a private civil matter.
Obviously this would be uneconomic for Novo Nordisk. You can't search anyone as you don't have any warrants, as it's not a crime and then even if you could, you need to prove that the drugs they have on them were purchased in Canada.
Foreigners who currently pay a huge amount of money would only have to make one trip to Canada in however long period it takes for the drugs to expire. I know I would certainly make a day trip if I was using this drug.
Intellectual property law firms offer services to renew and watch registrations like this worldwide and it would have been very simple to have a contract with one of them.
> Unlike the criminal law, Novo nordisk would have to go after every single person individually and make the case that they are infringing the American patent. This is all without the help of the police or customs, as a private civil matter.
I don't think that's quite right. One of the things that CBP does is inspect incoming shipments, and confiscate IP-infringing things.
Think about the recent Apple Watch SpO2 sensor patent shenanigans: The threat was to have CBP confiscate any infringing devices at the port of entry. I also remember that multimeters infringing on Fluke's ~~design patent~~ trademark have been blocked at the port of entry:
How practical is that for something the size of a couple pill bottles? Is that something customs would actually catch at all? They seem to have other priorities these days it seems.
> Canadian pharmacies can legally sell it and Americans (and all other foreigners for that matter) traveling there can legally buy it.
Well, about that... Aren't all variants of medications like these prescription-only? And in Canada you can't fill a foreign prescription without having a local doctor sign off on it, as far as I know.
US consumers would have to travel to Canada for injections which isn't practical unless you live on a border town.
It's unlikely to meet the bar for personal importation as you say.
That probably won't stop people from trying. There's already a huge market for illegal compounds and GPL-1 drugs are available alongside the usual testosterone and other steroids.
If you have a prescription from a provider in Canada, the limit for personal use is 90 days. As long as it is a legal drug in the US -- which I don't think necessarily includes that it's patented here, just that it's approved by the FDA.
> There's already a huge market for illegal compounds and GPL-1 drugs are available alongside the usual testosterone and other steroids.
The peptide and oils markets are both big, but largely separate -- the peptides folks don't seem to want to be associated with oils. Within peptides, GLP1s definitely dominate, though the other options are pretty popular. In my experience it seems like GLP1s are kind of a "gateway peptide" -- a lot of folks start with a GLP1 on the gray market, and then start to branch out and try the other options available.
Flights to Canada can be pretty cheap too. Less than the cost of one month so if you flew out every 90 days you’d still come out ahead. Practically not enough people will do this of course. Would be great for people in the border towns though.
Canada's one of the bigger markets for this product. That aside, think of the percentage of Americans that live driving distance of a Canadian border - it's easy to envision from meaningful lost sales just from normal Americans who go to Canada to shop on the weekend.
Not only that, there is a legitimate raft of companies lining up to make generics.
There’s one wrinkle though, legally importing prescription drugs from Canada isn’t really allowed in the US/UK AFAIK. HIMS is probably feverishly figuring out how to do that right now.
Absolutely -- certainly in their biggest markets they'll be able to protect those patents.
Both companies have thus far been unable to really stop compounding pharmacies and/or gray market suppliers from replicating though, and price negotiation with the government is definitely going to happen (Trump recently announced wanting $150 GLP1s, Novo's lawsuit against medicare price negotiation failed)... I do not have much faith in their ability to protect their pricing power for very long, which unfortunate for them is probably what's best for humanity and is very well known at this point.
>Novo Nordisk did not file for a renewal because of a mistake, or someone going on vacation, or anything like that.
>Novo Nordisk decided that the additional years of patent protection were not worth it compared to the advantage of the drug no longer being under the jurisdiction of the PMPRB <https://en.wikipedia.org/wiki/Patented_Medicine_Prices_Revie...>. Whether that decision was financially correct in light of GLP-1's subsequent application to weight loss, I do not know. However, again, it was not a silly mistake on Novo Nordisk's part.
I had never considered it-what makes a drug prescription vs OTC? Every substance has safety concerns(dose makes the poison), so with a lot of the financial gone, will the GLPs ever not require a prescription?
In the US, prescription and OTC are theoretically completely unrelated, but in practice patent holders want their drugs to be prescription, where end users aren't involved in the process of selecting or paying for the drug, whereas generic manufacturers want the drugs to be OTC, where end users are choosing the product in a competitive market.
See, for example, Prilosec (Omeprazole) switching from prescription to OTC.
The FDA (or equivalent in the relevant country) regulates whether an approved drug requires a prescription based on the safety profile. To be approved for OTC, there is a much higher bar in terms of ease of misuse, side effects, and so on.
It sounds like people will be flocking to Canada to fill their ozempic prescriptions. However, the WP just posted this article about how ordering rx meds from Canada has become unaffordable due to tariffs.
The whole story seems utterly insane to me. The fact that Novo Nordisk went back to ask for a refund of $250 they paid for the patent in 2017 shows that there was active intent behind this, this wasn't just some internal disconnect between payment systems that prevented the money from being sent to the government. Who at NN thought that saving, what, ~$1000 total was justified for this? I thought companies of this scale didn't even think on the scale of thousands of dollars anymore.
Oh well, at least we in Canada get more generic drug variants. Thanks!
Insane to the point that it doesn't seem believable. Even if the patent was worthless it wouldn't have been worth their time to pursue that refund just for the $250.
Another comment here mentioned that patents in Canada come with strings on pricing. So it's possible there was an actual trade-off that was considered here.
Apparently they can get around the government price controls by getting off the patent. I guess they figured it was better to keep prices high so americans didnt border hop but lose the exclusivity sooner
Possible, but considering that US Ozempic revenue is $10 billion per year between only Medicaid and Medicare, that would attract customs attention. The US market was projected to increase to $58 billion by 2035.
I think you may need to drive it across, not ship it, and the quantity limit is a 90 day supply. For people who live close enough to the border, it might be worth it.
There is nothing illegal about it. People get medicines from abroad all the time that are not generic domestically. It's not a controlled substance. One might have to go through unofficial channels though. In fact, I know people domestically who already get it cheaply from elsewhere abroad.
> In most circumstances, it is illegal for individuals to import drugs or devices into the U.S. for personal use because these products purchased from other countries often have not been approved by the FDA for use and sale in the U.S.
There are a million laws on the books that not only are not enforced, but aren't even self consistent with each other. It is enforcement that determines what one actually can or can't do. The enforcement exists for controlled substances, for resale, and for a supply of over 90 days. For personal non-commercial use of a non-controlled medicine for under 90 days, the law is not enforced, and for good reason. People would die if the law were to be enforced too strictly.
> Prof. Michael Hoffman from Toronto put me on to the Canadian Patent Database, where you can find that Novo did file a patent there for semaglutide. . .but the last time they paid the annual maintenance fee on it was 2018!
> You can even find a letter where their lawyers send a refund request for the 2017 maintenance fee ($250) because Novo apparently wanted some more time to see if they wanted to pay it.
> On the same date in 2019, the office sent a letter saying that “The fee payable to maintain the rights accorded by the above patent was not received by the prescribed due date. . .”
> By that time it was $450 with the late fee added, but that was apparently too much for Novo. They had a one year grace period to make it up, and apparently never did, so their patent lapsed in Canada. And as the Canadian authorities remind them, “Once a patent has lapsed it cannot be revived”.
Impressive failure for "the second-largest semaglutide market in the world."
I always wonder-in this case of such an epic company fuck up, does anyone ever get fired? Or is responsibility so diffuse that nobody is ultimately responsible?
Pharma companies are really nothing more than holders of time-limited, expensive, exclusive IP. The number one priority should be to maintain those protections as long as possible. How could any patent be allowed to lapse, even if there was limited commercial value, let alone, a blockbuster drug making billions?
Typically when people get fired for something like this they are just the scapegoat.
A failure like this isn't just one dude forgetting, its a system failure where policies and checks failed. If it is solely up to one person that is a failure in and of itself.
Some people, including legal experts, claim it could have been intentional: https://www.legal.io/articles/5691258/Novo-Nordisk-Lets-Cana....
I was surprised Science didn't discuss this option. However, reader comments in Science do comment on this possibility.
The idea is that letting the patent lapse would avoid getting regulated by the Patented Medicine Prices Review Board.
I know several people working at NN, and it's quite chaotic and political, so I wouldn't rule out an internal oversight.
Just FYI, this isn't "by Science", it's by Derek Lowe, this is his blog, which is hosted on Science>Commentary>Blogs. In its description, Lowe says it is "editorially independent".
Given how much of a blockbuster drug it is, wouldn't it be worth it for generics to rerun the trials in this specific case?
> If it is solely up to one person that is a failure in and of itself.
I would agree. The so-called bus factor has been common knowledge in the industries in question for literal decades now.
https://en.wikipedia.org/wiki/Bus_factor
> An early instance of this sort of query was when Michael McLay publicly asked, in 1994, what would happen to the Python language if Guido van Rossum were to be hit by a bus.
http://legacy.python.org/search/hypermail/python-1994q2/1040...
The process for the patent to lapse in Canada is quite long, and you get warning letters once deadlines are close.
There is also a possibility of a paying a late fee and, finally, there is also a reinstatement process.
NN could have missed all these, but they would have to be a really dysfunctional organization. Definitely not a low bus-factor situation.
I wasn’t casting aspersions on NN, but jumping off from the allusion that was made by the user who I replied to.
I don’t know what kind of sequence of events could lead to this outcome at NN, but perhaps they were hoist by their own petard. I’m reminded of the “money on the ground” joke involving two economists, which is semi-famous in these parts.
To wit:
> Economist 1: Look, there’s $20 on the ground!
> Economist 2: No there isn’t. If there were, someone would have picked it up already.
https://slatestarcodex.com/2014/06/19/money-on-the-ground/
https://news.ycombinator.com/item?id=28029044
Perhaps the folks at NN are so busy picking up (billions of) dollars that they neglect the dimes on the ground that it would cost to comply with these seemingly trivial, even menial functional requirements of keeping their money printer running.
I’m honestly as befuddled by this brouhaha as anyone. This is a monumental failure of multiple entire business units to perform the core competencies of their jobs. That said, I could honestly believe that the number of people whose job it is (or perhaps was) to worry about the patent expiry at all, let alone be aware of the repeated communiques from the Canadian patent office, is quite low. I would further believe that the accountability dodging has only just begun behind closed doors, if the internal game of megacorporate musical chairs hasn’t already concluded well before this news broke and reached the shores of HN.
Even at large corps, it's fairly common to outsource IP work to law firms that specialize in IP - and if you're Danish, it might make sense to outsource to a Danish law firm that has its own worldwide IP contacts (rather than getting your own worldwide branch offices to handle local IP laws everywhere). One of said contacts might then pawn off the work onto a junior, who then has their assistant handle all communiques from CIPO. Said assistant could then entirely drop the ball.
I've zero idea about anything specific to Novo Nordisk, but have enough exposure to IP in Canada to envision the above happening in other cases.
> Or is responsibility so diffuse that nobody is ultimately responsible
It doesn't take a very large company for this to happen. I've seen it in a sub 50 person company. There is a task to be done but no one can do it because everyone involved is waiting for someone else to do something. It's like a Mexican standoff.
Or is responsibility so diffuse that nobody is ultimately responsible?
That's exactly how things like this happen. No one has responsibility, thinking it's someone else's problem, so no one bothers to do the needful.
> thinking it's someone else's problem, so no one bothers to do the needful
Or it’s in someone’s political interest to let the fuckup play out.
after working in many companies for decades I can guarantee that the person responsible is some middle manager, who will just blame one of her/his workers who had that piece of work "deprioritised" to instead focus on the styling of a spreadsheet. The paper trail will point to the manager, who will just claim it was allocated to a problem character.
The cartharsis comes in knowing that them firing the innocent just keeps them repeating the mistake.
Is this the patent equivalent of letting your website's cert expire?
More like letting the domain expire, and someone else snapping it up before you can renew.
Canadian manufacturers (Sandoz and Apotex) are preparing to launch their own generic versions in early 2026.
I bet many Americans would travel to Canada to buy it there (despite the legality concerns). The medications lasts 2 years in a refrigerator.
If you're going to go for a two year supply, it's probably better to just risk shipping it. You're not going to come home with that much without it getting confiscated, and you're way more likely to be searched individually than a typical package is.
With de minimis for US-bound packages suspended I suspect way more packages are inspected than used to be.
> With de minimis for US-bound packages suspended I suspect way more packages are inspected than used to be
But a smaller fraction.
If you’re paranoid, route it via the UAE. All my European and Indian shippers are doing that for tariff-free pricing. (Personal stuff. I’ll pay a customs duty if I get it, of course.)
You can import from UAE without paying any duties or fees?
At least for wine, furniture, cheese, olive oil, art, kitchen equipment and medicine, at least from Italy and Germany and India and Taiwan, in the last six months, allegedly.
I mean that entire region has bought the president, even got themselves a military base being built on American land now too.
So why not.
You should be able to travel with a 90 day supply without issue.
Not an American but there’s only very limited circumstances you can travel across the border home to the USA with foreign prescription drugs, right? And this scenario wouldn’t cover it. Unless you just meant they won’t get caught or maybe not fined or confiscated in practice? :)
https://news.ycombinator.com/item?id=45638316
That's mainly for visitors. If you're a US resident, you can't just buy medicines abroad, unless of course we are talking about the "they won’t get caught" scenario.
US residents can buy medicines abroad the FDA link says personal importation is allowed as long as the medicines are FDA approved and are not being imported for commercial purposes. Now in the context of the original post maybe generic versions of Ozempic won't technically be FDA approved yet if the company that produces it has to wait for the US patent to expire.
The FDA approved version may be significantly cheaper to compete with the generic brands.
I also wonder if only the "active ingredients" need to be FDA approved, and the packaging is irrelevant?
Sounds like an opportunity for non-residents.
the shelf life is probably longer than that if you buy it in dehydrated form and don't hydrate it (but i have no idea)
While I'm all for saving costs, I would be shocked if mixing your own inject-able medicine either weekly (with the chance of making a mistake in dosage or sterility) or too such a high degree of sterility that you can confidentally store several doses is not worth the $200 return flight every two years. Maybe I'm overestimating the risks but it still seems like a small saving for it.
Realistically the cost of semiglutide in generic form means you could fly return every 90 days (personal import restriction for perscription meds) and still save $1000 every 3 months (3x$500 monthly - return flight - generic cost).
Its remarkably straightforward. Not fool-proof, but easy. Bacteriostatic water, single use needles/syringes, and self healing injection port vials makes it simple to maintain sterility throughout the process.
Multiple doses can be mixed and stored in the fridge for 4-6 weeks.
While I agree and this all seems reasonable, I think you give the average person far too much credit.
it's extremely common. everyone i know that's on a glp-1 does it this way. that way you can buy it in bulk for a discount. i buy mine roughly 35 weeks worth of doses at a time.
This is commonly done for injectable fertility treatments, though in my experience they are hydrated just before use.
I guess you get more shelf life, but it's an injectable drug.
You probably have to disolve it in very clean water in a very clean container. Do you have to match the salinity and pH with the proprties of the blood? How much time must you stir it to ensure it's completely disolved? Do you have to add something to increase/reduce viscosity? Some alcohol in case there are a few bacterias or improve solubility? How long does the small homemade batch last in the fridge?
IIUC there is another version in pills, they may have a longer shelf life, or not. But ask a medical doctor before taking a ramdom medicine.
Bacteriostatic water is widely available and you hydrate it in the container it comes in. Its pretty easy. I promise you you probably know someone on a glp-1 that is already doing this.
So cocaine from the south, ozempic from the north, fetanyl from the west and the meth is homegrown. So USA just need some powder from europe to close the circle.
That would be MDMA.
I bet many Americans would travel to Canada to buy it there
Why travel? There are thousands of ads on TV, radio, and the internet each day for Canadian pharmacies that promise to ship whatever you need to the U.S.
Um, what are the legality concerns? Is it illegal to bring medicine for your own use over the border? If not that, then what?
(Honest question. I don't know.)
https://www.fda.gov/industry/import-basics/personal-importat...
Just don’t do it in a speed boat.
This is impressive feat of bean counting. To save few thousand dollars, they lost market of few billion dollars. Good job.
I totally believe this happened.
If anyone has worked in a big, hidebound corporation, they are familiar with the "That's not my job" quandary.
That letter from lawyers probably cost more than 250 …
The sad thing is they probably were billed 500 dollars for the lawyers to “read” it.
I have an acquaintance working big law. They said the billing was "more offensive thank you could possibly imagine" ... but they took the money of course.
To be honest, given the efficiency of the drug and the huge benefit it could be to society, I feel like if I had been the employee in charge of filing patents I would've more than ready to lose my job in exchange for low cost general availability in the US via (illegal maybe, whatever) cross-border market. It's a nice loop hole and a great thing that once the delay expired they can't file ever again.
One's got to find ways to feel like the good guy when working for Big Pharma . That's probably not what happened but it's nice imagining it.
Maybe they'd even do it in exchange for just low-cost general availability in Canada!
AIUI, because they let the patent expire, the drug was not subject to price regulation by the government. So they could charge whatever.
And during most of that time, they were still protected by 'data exclusivity' which means that any generic producer could not get approved without doing their own clinical trials, until 8 years had passed.
So they gave up some period of exclusivity in return for being able to charge a higher price when they still had a monopoly.
The price in Canada is ~$175 USD month for name brand Ozempic where I am with no coupons, or other discounts. I see prices in the US around $800+/month.
That is significantly cheaper than the US, and cheaper than other GLP-1 class drugs up here, arguably reasonable. Is the supposition that they would have been forced to charge even less? If so, why are their competitors who kept their patents not charging more?
Counterpoint: Mounjaro/Tirzepatide did keep their patent protection. They are able to, and do, charge significantly more.
Everyone I know taking these is buying generic compounded formulas. Insurance mostly doesn’t cover it so the go for the cheaper options.
That doesn't figure into the pricing strategy or giving away patent protection in Canada in 2018 as far as I can tell?
Compounding isn't allowed in Canada, currently, so I assume you are talking about the US? Compounding Ozempic in the US wasn't a thing in 2018 when this patent was released in Canada, so not sure what one has to do with the other.
What are you getting at in reference to the argument that the patent was released intentionally in order to charge a higher price?
> Compounding isn't allowed in Canada
I'm not sure why you think that, compounding is allowed, I live right be a compounding pharmacy. And confirmed it's legal through google.
Yes I’m in the USA. I just mentioned that because nobody I know is paying $800/mo. They are buying compounded injections online.
> Compounding isn't allowed in Canada, currently
How does this work? Why/when would compounding not be allowed?
>And during most of that time
Most of what time? The patent just expired a few months ago. Generics are now ramping up because the patent expired, not because of some hypothetical eight year clinical trials. And for that matter, generics of existing ingredients and dosages do not have to repeat clinical trials anyways, which is one of the big reasons generics are a lot less expensive.
This hypothesis seems retconned and completely at odds with the actual facts. Not least that there has been absolutely nothing exceptional about the pricing of their product in Canada, which has always been one of the cheaper pricings worldwide.
Seems like a plausible explanation, the government should reform the price regulation laws to avoid this endrun around price controls.
Thanks, can you point to where you found this info?
Sorry, pieced together from different sources.
I am not an expert.
Here's one about the price control on patented drugs: https://www.torys.com/our-latest-thinking/publications/2024/...
See the comments on that article where a few people have pointed this out.
In Brazil it will expire in July 2026. It's pretty relevant as it's kinda already announced they will put the generics on the public health care (SUS) for free... Which is big deal as an Ozempic shot costs almost the same as the minimum wage.
This year they already did an analysis to include Ozempic, but it was denied, probably because of the cost difference...
But they were trying on justice to extend the patent...
being free means taxpayers will pay. and being on the public system means it will be prescribed only for health risk, just like plastic surgery already is. you don't see people getting nose jobs just because.
This is great news for Canadian public/private healthcare insurance. Not only do the drugs cost less but people get healthier and use less services
> Interviewer at Endpoints: You plan to potentially launch a generic GLP-1 in Canada and Brazil in 2026.
Looking at the original interview on Endpoints, Sandoz CEO Richard Saynor says this about Brazil:
In Brazil, the biggest prescribers are dentists. Everyone says, “Why dentists?” They do aesthetic work, and then you have your Botox, and then you want a bikini body. It’s behaving like an OTC consumer brand. Imagine selling this, rather than $300, at $50. Anybody over the age of 40 in Brazil will probably want to be on that.
But he doesn't explain how they got around the patents. Another comment on HN says they expire in July 2026, but can anyone explain why the patents expire so soon in Brazil?
1. In the USA people use compounding companies to get around patents.
2. https://www.reuters.com/business/healthcare-pharmaceuticals/...
I think that loophole has closed. If I recall correctly, compounding pharmacies were only allowed to do that as the US gov put the drug on a special list due to shortages. I believe they have removed it from this list (or will do shortly) and that pipeline will stop.
I thought I had a decent handle on patent law, but maybe I'm missing something here.
Yes, the patent won't be valid for Canada, but you can't import a product into the US which would infringe on a US patent.
So, though there may be a small amount that would slip through the cracks, it isn't as if anyone in the US can now manufacture Semaglutide and distribute it.
Canada is such a small market, that many companies don't bother. Though, for the cost, it seems ridiculous a company as big as Novo didn't pay the $500...that may even have been in Canadian dollars. :)
Don't worry about the law think about the practical impact. It's now completely legal to ignore the patent in Canada so the price in Canada will plummet.
Canadian pharmacies can legally sell it and Americans (and all other foreigners for that matter) traveling there can legally buy it.
Unlike the criminal law, Novo nordisk would have to go after every single person individually and make the case that they are infringing the American patent. This is all without the help of the police or customs, as a private civil matter.
Obviously this would be uneconomic for Novo Nordisk. You can't search anyone as you don't have any warrants, as it's not a crime and then even if you could, you need to prove that the drugs they have on them were purchased in Canada.
Foreigners who currently pay a huge amount of money would only have to make one trip to Canada in however long period it takes for the drugs to expire. I know I would certainly make a day trip if I was using this drug.
Intellectual property law firms offer services to renew and watch registrations like this worldwide and it would have been very simple to have a contract with one of them.
> Unlike the criminal law, Novo nordisk would have to go after every single person individually and make the case that they are infringing the American patent. This is all without the help of the police or customs, as a private civil matter.
I don't think that's quite right. One of the things that CBP does is inspect incoming shipments, and confiscate IP-infringing things.
Think about the recent Apple Watch SpO2 sensor patent shenanigans: The threat was to have CBP confiscate any infringing devices at the port of entry. I also remember that multimeters infringing on Fluke's ~~design patent~~ trademark have been blocked at the port of entry:
https://hackaday.com/2014/03/19/multimeters-without-a-countr...
How practical is that for something the size of a couple pill bottles? Is that something customs would actually catch at all? They seem to have other priorities these days it seems.
> Canadian pharmacies can legally sell it and Americans (and all other foreigners for that matter) traveling there can legally buy it.
Well, about that... Aren't all variants of medications like these prescription-only? And in Canada you can't fill a foreign prescription without having a local doctor sign off on it, as far as I know.
> you can't fill a foreign prescription without having a local doctor sign off on it
This is how medical tourism typically works.
Is that process that can happen online? Or does it require the patient being physically present in Canada?
Can be done virtually but you might have to use a VPN or even lie about your place of residence.
Plenty of countries where having a doctor in the pharmacy is common practice. Buy some retail space in YYZ and you're set...
> So, though there may be a small amount that would slip through the cracks
Probably depends on enforcement, price delta, and various other variables.
e.g. something like a quarter of smartphones sold in Brazil are smuggled in, more than a small amount slipping through the cracks.
Not that small. High income and roughly the same population as California, which isn't too small for companies to bother selling into.
Ozempic did about US$2bn of revenue in 2024 in Canada.
As Derek mentions, Canada is the second largest market. There may be a lot coming into the US already, legal or not.
$450 CAD I believe.
US consumers would have to travel to Canada for injections which isn't practical unless you live on a border town.
It's unlikely to meet the bar for personal importation as you say.
That probably won't stop people from trying. There's already a huge market for illegal compounds and GPL-1 drugs are available alongside the usual testosterone and other steroids.
If you have a prescription from a provider in Canada, the limit for personal use is 90 days. As long as it is a legal drug in the US -- which I don't think necessarily includes that it's patented here, just that it's approved by the FDA.
> There's already a huge market for illegal compounds and GPL-1 drugs are available alongside the usual testosterone and other steroids.
The peptide and oils markets are both big, but largely separate -- the peptides folks don't seem to want to be associated with oils. Within peptides, GLP1s definitely dominate, though the other options are pretty popular. In my experience it seems like GLP1s are kind of a "gateway peptide" -- a lot of folks start with a GLP1 on the gray market, and then start to branch out and try the other options available.
Flights to Canada can be pretty cheap too. Less than the cost of one month so if you flew out every 90 days you’d still come out ahead. Practically not enough people will do this of course. Would be great for people in the border towns though.
I don't know about that, Canada is a beautiful country. If I were on the meds, I wouldn't hesitate to fly out for a day trip every 90 days.
Also, let's be real, anyone in the northeast could be there in a few hours driving. New York City is about 7 hours away from Ottawa, for example.
Detroit and Windsor are a single bridge crossing away from each other. Sarnia and Port Huron too.
I’ve ended up at the border crossing from Niagara Falls to Buffalo by accident before. I was glad when they let me make a U-turn.
There's a tunnel between Detroit and Windsor. Faster than the bridge sometimes because no trucks.
You're probably right. I scanned the FDA website and wasn't sure how easy it would be to meet the requirements for personal medicine importation [0].
As a Canadian national in the US I wouldn't even attempt doing this in the current political climate.
[0] https://www.fda.gov/industry/import-basics/personal-importat...
Canada's one of the bigger markets for this product. That aside, think of the percentage of Americans that live driving distance of a Canadian border - it's easy to envision from meaningful lost sales just from normal Americans who go to Canada to shop on the weekend.
We don't have laws anymore. Just pay off POTUS so he can declare cheap "fat shots" and let Kushner or Barron own the importer, and you're good.
Not only that, there is a legitimate raft of companies lining up to make generics.
There’s one wrinkle though, legally importing prescription drugs from Canada isn’t really allowed in the US/UK AFAIK. HIMS is probably feverishly figuring out how to do that right now.
Shameless plug:
https://glp1guide.substack.com/p/another-glp1-generic-launch...
Also somewhat separately, injectable GLP1s are about to be upstaged by oral variants — orfoglipron for Eli Lilly and the Wegovy Pill for Novo.
> Also somewhat separately, injectable GLP1s are about to be upstaged by oral variants — orfoglipron for Eli Lilly and the Wegovy Pill for Novo.
I believe that this gets a new patent, and will probably be a huge seller.
Absolutely -- certainly in their biggest markets they'll be able to protect those patents.
Both companies have thus far been unable to really stop compounding pharmacies and/or gray market suppliers from replicating though, and price negotiation with the government is definitely going to happen (Trump recently announced wanting $150 GLP1s, Novo's lawsuit against medicare price negotiation failed)... I do not have much faith in their ability to protect their pricing power for very long, which unfortunate for them is probably what's best for humanity and is very well known at this point.
looking at the filing, they had their patent deadline extended due to COVID-19 eighteen times!
https://brevets-patents.ic.gc.ca/opic-cipo/cpd/eng/patent/26...
Quoting myself <https://np.reddit.com/r/MapPorn/comments/1md4wde/the_most_va...>:
>Novo Nordisk did not file for a renewal because of a mistake, or someone going on vacation, or anything like that.
>Novo Nordisk decided that the additional years of patent protection were not worth it compared to the advantage of the drug no longer being under the jurisdiction of the PMPRB <https://en.wikipedia.org/wiki/Patented_Medicine_Prices_Revie...>. Whether that decision was financially correct in light of GLP-1's subsequent application to weight loss, I do not know. However, again, it was not a silly mistake on Novo Nordisk's part.
I had never considered it-what makes a drug prescription vs OTC? Every substance has safety concerns(dose makes the poison), so with a lot of the financial gone, will the GLPs ever not require a prescription?
In the US, prescription and OTC are theoretically completely unrelated, but in practice patent holders want their drugs to be prescription, where end users aren't involved in the process of selecting or paying for the drug, whereas generic manufacturers want the drugs to be OTC, where end users are choosing the product in a competitive market.
See, for example, Prilosec (Omeprazole) switching from prescription to OTC.
The FDA (or equivalent in the relevant country) regulates whether an approved drug requires a prescription based on the safety profile. To be approved for OTC, there is a much higher bar in terms of ease of misuse, side effects, and so on.
It sounds like people will be flocking to Canada to fill their ozempic prescriptions. However, the WP just posted this article about how ordering rx meds from Canada has become unaffordable due to tariffs.
Many seniors get cheaper medicine from Canada. That might become harder https://www.washingtonpost.com/business/2025/10/18/deminimis...
No paywall: https://archive.ph/nT0Jl
The whole story seems utterly insane to me. The fact that Novo Nordisk went back to ask for a refund of $250 they paid for the patent in 2017 shows that there was active intent behind this, this wasn't just some internal disconnect between payment systems that prevented the money from being sent to the government. Who at NN thought that saving, what, ~$1000 total was justified for this? I thought companies of this scale didn't even think on the scale of thousands of dollars anymore.
Oh well, at least we in Canada get more generic drug variants. Thanks!
Insane to the point that it doesn't seem believable. Even if the patent was worthless it wouldn't have been worth their time to pursue that refund just for the $250.
Another comment here mentioned that patents in Canada come with strings on pricing. So it's possible there was an actual trade-off that was considered here.
Apparently they can get around the government price controls by getting off the patent. I guess they figured it was better to keep prices high so americans didnt border hop but lose the exclusivity sooner
There's about to be a lot of skinny people in Canada bordering states. :)
So would it be possible to buy the drug in Canada and ship to US?
Smuggling aside, they generally won't make it through customs: https://www.help.cbp.gov/s/article/Article-1815?language=en_...
Possible, but considering that US Ozempic revenue is $10 billion per year between only Medicaid and Medicare, that would attract customs attention. The US market was projected to increase to $58 billion by 2035.
I think you may need to drive it across, not ship it, and the quantity limit is a 90 day supply. For people who live close enough to the border, it might be worth it.
not legally, but anything is possible
There is nothing illegal about it. People get medicines from abroad all the time that are not generic domestically. It's not a controlled substance. One might have to go through unofficial channels though. In fact, I know people domestically who already get it cheaply from elsewhere abroad.
> In most circumstances, it is illegal for individuals to import drugs or devices into the U.S. for personal use because these products purchased from other countries often have not been approved by the FDA for use and sale in the U.S.
https://www.fda.gov/industry/import-basics/personal-importat...
There are a million laws on the books that not only are not enforced, but aren't even self consistent with each other. It is enforcement that determines what one actually can or can't do. The enforcement exists for controlled substances, for resale, and for a supply of over 90 days. For personal non-commercial use of a non-controlled medicine for under 90 days, the law is not enforced, and for good reason. People would die if the law were to be enforced too strictly.