Hims & Hers Health unveiled plans Wednesday to introduce generic semaglutide in Canada, capitalizing on the impending lapse of Novo Nordisk‘s patent for its blockbuster drugs Ozempic and Wegovy this January. The move positions Hims & Hers as a key player in offering potentially more affordable weight loss solutions to the Canadian market.
“Canada presents a significant opportunity to redefine accessible, high-quality weight management,” stated Andrew Dudum, co-founder and CEO of Hims & Hers, in a press release. “With generic semaglutide becoming available globally for the first time, our focus is on ensuring genuine accessibility by combining affordability with trusted, personalized care at scale.” The company belives that it can make a meaningful difference in the market.
Hims & Hers, primarily known as a telehealth platform, joins a growing cohort of pharmaceutical companies vying for a share of the market following Novo Nordisk’s patent expiration on its GLP-1 receptor agonists. This venture marks the company’s inaugural foray into the Canadian market. Some believe that this could pose a threat to other companies in the space.
Generic drugs, bioequivalent copies of brand-name medications like Ozempic and Wegovy, are designed to deliver the same therapeutic effect and adhere to identical safety standards once the original patent protections expire. These differ substantially from compounded medications, which are customized formulations tailored to individual patient needs, often involving alterations in dosage or form compared to commercially available drugs.
Market research suggests a substantial opportunity. According to Grand View Research, the Canadian semaglutide market generated $1.18 billion in revenue in 2024 and is projected to reach $4.03 billion by 2035.
Despite the impending patent lapse, no generic semaglutide version has yet received approval from Health Canada, the country’s regulatory agency. However, several companies have initiated the approval process. Whether or not these applications will be approved reamains to be seen.
Sandoz, a prominent player in generic drug manufacturing, reported to Science in early June that they had submitted an application to Health Canada for approval of its generic semaglutide version. Hims & Hers did not disclose whether they had begun a similar application process but emphasized their collaboration with “an approved partner” to ensure compliance with all relevant Canadian laws and regulations. One major question on investor’s minds is when the application was submitted.
The move is expected to drastically shift the market. For patients like Sarah M., a 42-year-old from Toronto who has struggled with weight management for years, the prospect of affordable semaglutide is a game-changer. “I’ve seen the ads for Ozempic and Wegovy,” she says, “but the cost is just prohibitive. This is a story we need to tell,” she added, emphasizing the potential for life-changing access to medication. Her insurance company told her that even if she were approved, they would not cover the cost of the drug.
The announcement has sparked discussion on social media, with many Canadians expressing hope for more affordable weight management options. “Finally, maybe I can actually afford to try something that might work,” commented one user on X.com. Others cautioned about potential side effects and the importance of consulting with a doctor before starting any new medication. Some health care proffessionals expressed concern about the impact of weight loss drugs on overall population health.
- Lower cost of semaglutide due to generic production
- Increased accessibility through Hims & Hers’ telehealth platform
- Potential impact on the Canadian healthcare system
- Competitive landscape with other generic manufacturers
Some industry observers have voiced concerns about Novo Nordisk’s apparent oversight in allowing its Canadian patent to lapse. The situation comes as Wegovy faces increasing competition from Eli Lilly‘s Zepbound in the U.S. market. A Novo Nordisk spokesperson assured 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.” While the company maintains its position on the matter, others are not so sure.
This announcement follows Hims & Hers’ recent acquisition of Zava, a European telehealth platform, expanding its reach into Ireland, France, and Germany. The company has been aggressively expanding its offerings and global reach. The recent acquisition is an important next step in that direction.
Interestingly, this development occurs after Novo Nordisk ended its collaboration with Hims & Hers, citing concerns regarding the company’s sales and promotional activities surrounding cheaper alternatives to Wegovy. The end of the previous partnership is not expected to have a large impact on either business.
How Novo Lost Its Canadian Patent: An Unexpected Turn
According to documents available on the Canadian Patent Database, Novo Nordisk held a patent for semaglutide, but records show that the last annual maintenance fee payment was made in 2018. Some consider this to be a major misstep by the company.
Letters included in the documents reveal that Novo Nordisk’s legal representatives requested a refund for the CA$250 (US$185) maintenance fee paid in 2017, citing the company’s need for more time to assess whether to continue patent maintenance. Why the company considered this to be a good idea is unknown.
Two years later, authorities notified Novo Nordisk that the outstanding fee, now totaling CA$450 due to late charges, had not been received by the deadline. This seemed to signal the end of Novo’s semaglutide patent in Canada.
Despite a one-year grace period to rectify the situation, Novo Nordisk failed to make the payment, leading to the patent’s lapse in Canada. Although the fee remained unpaid by 2020, the patent’s expiration is formally set for January 2025. Many are wondering how the company let this happen.
Canadian authorities confirmed that “once a patent has lapsed it cannot be revived.” This determination effectively closed the door to any potential efforts by Novo to reinstate the patent.
This series of events has baffled many experts in intellectual property law. “It’s exceedingly rare for a major pharmaceutical company to overlook something like this,” says Dr. Evelyn Reed, a patent law specialist at McGill University. “The cost of maintaining a patent is minimal compared to the potential revenue generated by drugs like Ozempic and Wegovy. The fact that Novo Nordisk simply let it lapse suggests either a serious administrative oversight or a strategic decision that has backfired spectacularly.” It may take months or years to determine the reason.
“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,” asserted David Meinertz, general manager of the international business at Hims & Hers. The company has made it a priority to make healthcare accessable.