Novo Nordisk patent protections lapse in Canada
Novo Nordisk's patent protections lapse early after forgetting to pay a small fee allows a Canadian Generic to get to market faster.
One of the greatest ways to increase accessibility of GLP1s is via patent protection expiration – being able to make generics dramatically reduces costs and helps more people access GLP1s.
We try to keep up with when patents are expected to lapse, but only for the US market. Clearly more exciting news is happening elsewhere.
What happened?
An executive reported during an interview that they were launching a Semaglutide generic, and detailed the how:
This information was first Reported via Endpoints, and the important quote is below:
Dunn (interviewer at Endpoints): You plan to potentially launch a generic GLP-1 in Canada and Brazil in 2026. What do you expect for the biosimilar market, both there and eventually in the US?
Saynor: Canada, we filed and are waiting for approval once the data exclusivity expires sometime in Q1 next year. Interesting market. Novo never filed a patent in Canada. Never know why. I’m sure someone’s lost their job, but never mind. It’s the second-largest semaglutide market in the world.
Novo Nordisk did file a patent, but what's even more surprising is that they hadn't paid a fee for years, according to the canadian patent database. Novo Nordisk forgot to pay the bill in 2019, while they'd successfully paid it in 2018.
Given that the fee was only $450 (less than the price of one month of Semaglutide, in many places), and Novo Nordisk didn't pay it, it must have been a clerical error.
Sandoz is a large multi-national pharamaceutical company (formerly part of Novartis) that regularly creates generics:
Contributors to Wikimedia projects
They are extremely likely to be able to properly launch their Semaglutide generic as they have stated in 2026.
Novo Nordisk did forget to pay a fee, but protection was already expiring.
Interesting commentary is reporting that this may have been an intentional move by Novo Nordisk, as patent protection was due to lapse in 2026 regardless of extension.
It's possible this was intentional, but companies are certainly not known for leaving 6 months of exclusivity (and thus increased profit) on the table. This lapse enables competitors to have a quicker start, and just doesn't seem worth the risk.
With reports from multiple sources, it seems that relevant employees at Novo Nordisk really did forget to pay a fee that would extend their Semaglutide patent just a little longer.
That said, patent protection for Novo Nordisk's Semaglutide GLP1 Receptor Agonist formulation in Canada was already due to expire in 2025.
What does this mean for other GLP1 markets?
The largest effect is unsurprisingly going to be on the US market for GLP1. In the US, Novo Nordisk's Semaglutide patent does not expire until at least 2032 – but it's already an incredibly popular drug, with popularity only growing.
Semaglutide isn't the best GLP1 Receptor Agonist in the US (Tirzepatide, produced by Eli Lilly currently is), but it has the most recognizable brand name – Ozempic.
So does this mean that everyone is going to simply purchase their Ozempic from Canada? Not so fast:
Cindy George, MPH
States and consumers in the US cannot simply import prescription medications from Canada – they must be approved and allowed by the FDA.
States and Indian Tribes could apply
One possible avenue for interested states or indian tribes is to petition the FDA under the importation program:
Office of the Commissioner
As the US is a southern neighbor of Canada, the amount of "cross border" grey market demand is going to be incredible – companies and individuals that have no problem getting to Canada and purchasing directly will also benefit.
Canadian wholesalers may already qualify
A great comprehensive research-grade overview of drug importation from Canada can be found here:
✉Correspondence to: Nigel Rawson, EastlakeRGgmail.com
In fact, certified Canadian wholesale distributors may already be able to sell into the US (emphasis and spacing added):
Certified sellers would be Canadian wholesale distributors or licensed pharmacies engaged in the distribution of prescription drugs for importation under the legislation,
have been in business for at least five years and
have a purpose other than the export program.
Sellers would need to receive a valid prescription before supplying drugs to individuals.
They would also have to certify that their physical premises, data-reporting procedures and licences are in compliance with all applicable Canadian laws and regulations, and have policies to monitor compliance.
Sellers would have to pay a fee to fund the administration and enforcement of the program.
These requirements seem relatively easy for Canadian wholesalers who quality to satisfy.
Would the current administration support importing?
Lowering the cost of prescription drugs and healthcare is one of the stated goals of the current administration, but it's unclear if the current administration would support importing said cheaper drugs from a neighbor.
In this case the trade war and the reality of cheaper drugs (that must be imported) is a bit of a conflict for current US domestic policy.
Mistake or not, GLP1 supply is about to increase
While the news from compounding pharmacies and the ongoing battle over getting access to GLP1s has been bleak, this development shows that there is relief coming.
Despite the current administration and ongoing trade war, increased accessibility to Semaglutide is coming in 2026 via an unexpected avenue: Canadian suppliers.
