Canada Just Got Generic Ozempic. Americans Shouldn’t Hold Their Breath

1 day ago 4

The era of cheap, officially approved semaglutide is finally here—in Canada, that is. The country has just become the first in North America and the first G7 nation to license a generic version of the popular weight loss and diabetes treatment.

On Tuesday, Health Canada authorized an application for generic semaglutide submitted by the company Dr. Reddy’s Laboratories. This version, and others like it, will be significantly less expensive than the brand-name drugs currently sold by Novo Nordisk. Americans will probably have to wait at least half a decade before such products will be approved in the U.S., however.

“The availability of generic drugs is expected to have a positive impact in Canada, including potential cost savings for patients and the healthcare system,” Health Canada stated in its announcement of the approval.

A generic milestone

Semaglutide is the active ingredient in the brand-name type 2 diabetes drug Ozempic and the obesity drug Wegovy. It mimics the hormone GLP-1, which helps regulate our hunger and insulin production, among other things.

It and other newer GLP-1s have greatly reshaped diabetes and obesity treatment for the better in recent years. These medications help people lose substantially more weight than diet and exercise alone (an average of 15% over a year’s time in trials of Wegovy). These drugs have their drawbacks, though, including cost. Even with sizeable price drops as of late, maintenance doses of injectable Wegovy can still cost around $200 to $350 a month without insurance (and insurance providers frequently deny coverage).

As a rule, drugs become much more inexpensive once other companies can produce generic versions of them, which is why pharmaceuticals typically do everything they can to delay the expiration of their relevant patents. In Canada, however, Novo Nordisk failed to pay a simple annual maintenance fee starting in 2019, allowing its patents in the country to expire early this January. Dr. Reddy’s Laboratories is one of nine companies that have filed to produce generic semaglutide in Canada, according to Health Canada, while Novo Nordisk won approval for its own generics late last year.

Though it will likely take several months for the first generics to reach the market, they’ll certainly drive prices down. Experts have stated that generic semaglutide in Canada will probably cost around C$100 a month, which will likely decrease over time as more competitors arrive (GLP-1s are not currently covered by Canada’s public health care system, and, as in the U.S., insurance does not always cover them). Novo Nordisk’s patents also expired this year in India (unlike the U.S. or other countries, India doesn’t allow patent extensions), and prices there have already reportedly dropped even more substantially.

But not for the US

Unfortunately for Americans, there was no such clerical oversight in the U.S. Novo Nordisk’s major semaglutide-related patents here will not start to expire until late 2031, meaning generics probably won’t enter the market until 2032 at the earliest.

Since the arrival of Wegovy, there’s also been a burgeoning grey market of cheaper, compounded GLP-1s. Both Novo Nordisk and the Food and Drug Administration are trying to severely squash this market, however, meaning people’s easy access to these riskier products may dry up sooner rather than later.

At least 13 companies have already expressed interest in producing generics in the U.S., so there’s likely to be plenty of options once they become available. But for now, discount-loving Americans will have to bide their time.

Read Entire Article