Hims & Hers to offer generic semaglutide in Canada as Novo Nordisk patent lapses

Hims & Hers Health announced Wednesday it volition connection generic semaglutide successful Canada arsenic Novo Nordisk's patent connected its branded drugs Ozempic and Wegovy is acceptable to expire successful January.

"Canada is simply a large accidental to amusement what affordable, high-quality value nonaccomplishment attraction tin look like," said Andrew Dudum, co-founder and CEO of Hims & Hers, successful a property release. "As generic semaglutide becomes disposable for the archetypal clip globally, we're focused connected making it genuinely accessible, by combining affordability with trusted, personalized attraction astatine scale." 

Hims, a telehealth platform, joins a increasing database of drugmakers that are looking to currency successful connected Novo Nordisk's lapsed patent connected its GLP-1s. It's the archetypal clip the institution volition beryllium operating successful Canada.

Generics are fundamentally copies of a brand-name drug, similar Ozempic oregon Wegovy, that present the aforesaid efficacy, travel the aforesaid information standards and are allowed erstwhile a patent expires. These drugs are antithetic from compounded versions of medications, which are personalized treatments that are changed successful signifier oregon provided successful antithetic dosing levels than commercially disposable doses.

The Canadian semaglutide marketplace successful 2024 generated gross of $1.18 cardinal and is expected to scope $4.03 cardinal by 2035, according to marketplace probe steadfast Grand View Research.

There is inactive nary generic mentation of semaglutide connected the marketplace that's been approved by the Canadian wellness agency, but the support process has begun for immoderate successful the industry.

Sandoz, a planetary person successful generic medicine manufacturing, told Science in aboriginal June that it filed for support of a generic mentation of semaglutide with Canada's regulatory bureau Health Canada. Hims did not accidental successful its announcement if it has started a akin exertion for review, but did enactment it's moving with "an approved partner" to guarantee it's pursuing each section laws and regulations.

Some successful the manufacture person raised concerns astir Novo letting its patent lapse, and it comes arsenic Wegovy has lost ground to Eli Lilly's rival treatment, Zepbound, successful the U.S. But a spokesperson for the institution told CNBC that each intelligence spot decisions are "carefully considered," adding that "periods of exclusivity for pharmaceutical products extremity arsenic portion of their mean beingness rhythm and generic treatments whitethorn go disposable implicit time."

This announcement by Hims follows the closing of the company's caller acquisition of European telehealth level Zava, which expands the wellness level successful Europe to Ireland, France and Germany.

This besides comes aft Novo Nordisk ended its collaboration with Hims & Hers, citing concerns astir the company's income and promotion of cheaper knockoffs of its value nonaccomplishment cause Wegovy.

According to documents filed with the Canadian Patent Database, Novo held a patent for semaglutide, but the past clip the institution paid the yearly attraction interest was successful 2018.

Novo Nordisk's lawyers requested a refund for the paid 2017 attraction interest of $250 Canadian dollars ($185) due to the fact that the institution wanted much clip to spot if it wanted to wage it, according to letters included successful the documents.

Two years later, the bureau sent a missive saying the fee, which present included a precocious complaint bringing the full to CA$450, was not received by the prescribed owed date.

Novo Nordisk had a one-year grace play to pay, but ne'er did, and truthful its patent lapsed successful Canada. It lapsed successful 2020 erstwhile the interest was not received, but it doesn't expire until January.

Canadian authorities confirmed successful their correspondence that "once a patent has lapsed it cannot beryllium revived."

"Making affordable, holistic obesity attraction accessible has the imaginable to assistance fortify the section healthcare strategy and unlock the imaginable for millions of Canadians to unrecorded healthier, much fulfilling lives," said David Meinertz, wide manager of the planetary concern astatine Hims & Hers.