Hims & Hers provides generic semaglutide as Novo Nordisk patent lapses

Hims & Hers Health introduced Wednesday it’s going to supply generic semaglutide in Canada as Novo Nordisk‘s patent on its branded medicine Ozempic and Wegovy is about to run out in January.

“Canada is a significant alternative to indicate what inexpensive, high-quality weight reduction care can seem like,” mentioned Andrew Dudum, co-founder and CEO of Hims & Hers, in a press launch. “As generic semaglutide turns into accessible for the primary time globally, we’re centered on making it actually accessible, by combining affordability with trusted, customized care at scale.” 

Hims, a telehealth platform, joins a rising listing of drugmakers that need to money in on Novo Nordisk’s lapsed patent on its GLP-1s. It is the primary time the corporate will probably be working in Canada.

Generics are primarily copies of a brand-name drug, like Ozempic or Wegovy, that ship the identical efficacy, comply with the identical security requirements and are allowed as soon as a patent expires. These medicine are completely different from compounded variations of medicines, that are customized remedies which are modified in kind or offered in several dosing ranges than commercially accessible doses.

The Canadian semaglutide market in 2024 generated income of $1.18 billion and is predicted to succeed in $4.03 billion by 2035, in keeping with market analysis agency Grand View Research.

There’s nonetheless no generic model of semaglutide available on the market that is been accredited by the Canadian well being company, however the approval course of has begun for some within the trade.

Sandoz, a world chief in generic drugs manufacturing, told Science in early June that it filed for approval of a generic model of semaglutide with Canada’s regulatory company Health Canada. Hims didn’t say in its announcement if it has began an identical utility for evaluation, however did be aware it is working with “an accredited accomplice” to make sure it is following all native legal guidelines and laws.

Some within the trade have raised considerations about Novo letting its patent lapse, and it comes as Wegovy has lost ground to Eli Lilly‘s rival therapy, Zepbound, within the U.S. However a spokesperson for the corporate informed CNBC that every one mental property selections are “fastidiously thought of,” including that “durations of exclusivity for pharmaceutical merchandise finish as a part of their regular life cycle and generic remedies might turn into accessible over time.”

This announcement by Hims follows the closing of the corporate’s current acquisition of European telehealth platform Zava, which expands the well being platform in Europe to Eire, France and Germany.

This additionally comes after Novo Nordisk ended its collaboration with Hims & Hers, citing considerations concerning the firm’s gross sales and promotion of cheaper knockoffs of its weight reduction drug Wegovy.

In line with paperwork filed with the Canadian Patent Database, Novo held a patent for semaglutide, however the final time the corporate paid the annual upkeep price was in 2018.

Novo Nordisk’s attorneys requested a refund for the paid 2017 upkeep price of $250 Canadian {dollars} ($185) as a result of the corporate wished extra time to see if it wished to pay it, in keeping with letters included within the paperwork.

Two years later, the workplace despatched a letter saying the price, which now included a late cost bringing the full to CA$450, was not acquired by the prescribed due date.

Novo Nordisk had a one-year grace interval to pay, however by no means did, and so its patent lapsed in Canada. It lapsed in 2020 when the price was not acquired, however it would not expire till January.

Canadian authorities confirmed of their correspondence that “as soon as a patent has lapsed it can’t be revived.”

“Making inexpensive, holistic weight problems therapy accessible has the potential to assist strengthen the native healthcare system and unlock the potential for tens of millions of Canadians to reside more healthy, extra fulfilling lives,” mentioned David Meinertz, normal supervisor of the worldwide enterprise at Hims & Hers.