Hims & Hers to offer generic semaglutide in Canada as Novo Nordisk patent lapses
"Canada is a major opportunity to show what affordable, high-quality weight loss care can look like," said Andrew Dudum, co-founder and CEO of Hims & Hers, in a press release. "As generic semaglutide becomes available for the first time globally, we're focused on making it truly accessible, by combining affordability with trusted, personalized care at scale."
Hims, a telehealth platform, joins a growing list of drugmakers that are looking to cash in on Novo Nordisk's lapsed patent on its GLP-1s. It's the first time the company will be operating in Canada.
Generics are essentially copies of a brand-name drug, like Ozempic or Wegovy, that deliver the same efficacy, follow the same safety standards and are allowed once a patent expires. These drugs are different from compounded versions of medications, which are personalized treatments that are changed in form or provided in different dosing levels than commercially available doses.
The Canadian semaglutide market in 2024 generated revenue of $1.18 billion and is expected to reach $4.03 billion by 2035, according to market research firm Grand View Research.
There is still no generic version of semaglutide on the market that's been approved by the Canadian health agency, but the approval process has begun for some in the industry.
Sandoz, a global leader in generic medicine manufacturing, told Science in early June that it filed for approval of a generic version of semaglutide with Canada's regulatory agency Health Canada. Hims did not say in its announcement if it has started a similar application for review, but did note it's working with "an approved partner" to ensure it's following all local laws and regulations.
Some in the industry have raised concerns about Novo letting its patent lapse, and it comes as Wegovy has lost ground to Eli Lilly's rival treatment, Zepbound, in the U.S. But a spokesperson for the company told CNBC that all intellectual property decisions are "carefully considered," adding that "periods of exclusivity for pharmaceutical products end as part of their normal life cycle and generic treatments may become available over time."
This announcement by Hims follows the closing of the company's recent acquisition of European telehealth platform Zava, which expands the health platform in Europe to Ireland, France and Germany.
This also comes after Novo Nordisk ended its collaboration with Hims & Hers, citing concerns about the company's sales and promotion of cheaper knockoffs of its weight loss drug Wegovy.
According to documents filed with the Canadian Patent Database, Novo held a patent for semaglutide, but the last time the company paid the annual maintenance fee was in 2018.
Novo Nordisk's lawyers requested a refund for the paid 2017 maintenance fee of $250 Canadian dollars ($185) because the company wanted more time to see if it wanted to pay it, according to letters included in the documents.
Two years later, the office sent a letter saying the fee, which now included a late charge bringing the total to CA$450, was not received by the prescribed due date.
Novo Nordisk had a one-year grace period to pay, but never did, and so its patent lapsed in Canada. It lapsed in 2020 when the fee was not received, but it doesn't expire until January.
Canadian authorities confirmed in their correspondence that "once a patent has lapsed it cannot be revived."
"Making affordable, holistic obesity treatment accessible has the potential to help strengthen the local healthcare system and unlock the potential for millions of Canadians to live healthier, more fulfilling lives," said David Meinertz, general manager of the international business at Hims & Hers.
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