Ozempic® Patent Expiry: Have the Scales Finally Tipped?

Few pharmaceutical products have captured public attention in recent years quite like Ozempic®, Novo Nordisk’s blockbuster semaglutide drug. Approved in 2017 for the treatment of type 2 diabetes, Ozempic® is a GLP-1 receptor agonist that lowers blood glucose levels. Its well-documented appetite-suppressing effects, and the associated weight loss, quickly pushed the drug beyond the diabetes market and into public consciousness as a weight loss treatment.

Novo Nordisk subsequently developed Wegovy®, which contains the same active ingredient, semaglutide, but is specifically approved for chronic weight management. Despite different approved uses, both products share the same underlying patent foundation.

The Foundational Patent
Both Ozempic® and Wegovy® are based on semaglutide. Novo Nordisk’s foundational patent covering the compound, PCT application WO2006097537A2, has a filing date of 20 March 2006. In countries applying the standard 20-year patent term, the key national patents in this family expired on 20 March 2026.

As a result, compound patent protection for semaglutide has now ended in several major markets, including India, China, Brazil and South Africa. In Canada, the granted patent in this family (CA2601784C) was allowed to lapse, and no legal remedies are available to re-establish the rights. The expiry or loss of rights of the foundational patent in these jurisdictions has therefore removed the primary barrier to generic manufacture and sale of semaglutide for both diabetes and weight-management uses.

Generic Entry
In India, within 24 hours of the expiry of the foundational semaglutide patent, an immediate wave of generic launches was triggered. With India being home to around 90 million people living with diabetes and over 250 million adults classified as obese, there is an enormous unmet clinical need (1,2). More than 40 Indian pharmaceutical companies including Cipla, Sun Pharma, Dr Reddy's Laboratories, Biocon, Natco, Zydus and Mankind Pharma have launched or are in the final stages of launching generic semaglutide (3,4). By way of example, Dr Reddy’s Laboratories has launched Obeda™, Sun Pharma has launched Noveltreat™, and Zydus has launched Semaglyn™. Prices have significantly collapsed, with reductions reportedly as high as 50-80% compared to the branded product (4,5). The rapid market entry reflects both India’s strong generics industry and the scale of demand for affordable diabetes and weight-management therapies.

There is broader significance to what is happening in India, considering that India supplies approximately 20% of global off-patent medicines. Dr. Reddy’s, for instance, has already announced plans to export its generic semaglutide into Canada, Turkey and Brazil, targeting 12 million pens in the first year across all markets.

In China, the foundational patent CN101133082B also expired on 20 March 2026, and with an estimated 148 million adults living with diabetes, the largest diabetic population in the world as well as a fast-growing obesity burden, the commercial opportunity is vast. At least 16 Chinese pharmaceutical companies are developing generic semaglutide, with some already at Phase III clinical trial stage (6).

While the expiry of the primary semaglutide patent in many jurisdictions is significant, it does not mean Ozempic® is free for generic manufacture worldwide.

In Europe, the semaglutide compound benefits from Supplementary Protection Certificates (SPCs), extending protection until March 2031. In the United States, patent term extensions are expected to keep patent protection in place until at least 2032. Similar extensions apply in Japan, where protection is expected to last until approximately 2031.

In addition to these term extensions, Novo Nordisk has built an extensive secondary patent portfolio around semaglutide, including patents directed to manufacturing processes, methods of treatment, formulations, dosing regimens, injector pens and delivery device patents.

These secondary patents will expire later than Novo Nordisk’s foundational patent and have the potential to delay or complicate market entry by generic manufacturers.

Generic versions of Ozempic® and Wegovy® are already entering, and are expected to flood markets, such as India and China. However, whether those generic versions can obtain all necessary regulatory approvals and commercial scale‑up while being clinically comparable in efficacy, without infringing Novo Nordisk’s secondary patents, remains to be seen. 

Pharmaceutical IP Strategy
Ozempic® and Wegovy® illustrate that the notion of a single “patent cliff” is increasingly disconnected from commercial reality. Modern pharmaceutical exclusivity rarely hinges on a lone compound patent expiring on a given date. Instead, market protection is maintained through layered and interlocking rights that delay effective generic entry long after the core patent has fallen away.

From an IP strategy perspective, the Ozempic® and Wegovy® portfolios demonstrate the value of early and sustained follow-on patent filing to extend commercial exclusivity beyond the foundational patent. They also show the strategic importance of SPCs and equivalent term extensions in delaying loss of exclusivity in major markets.

For both patent owners and generic manufacturers, this underscores a critical shift. Market entry is no longer determined by a single expiry date, but by navigating a dense ecosystem of patents, regulatory protections and litigation risks. The coming years will provide a clear understanding of how generic entry of these weight‑management drugs affects global markets and the risks generic manufacturers must face.

Please get in touch if you would like to discuss this topic further.

We are a European firm and assist our clients to protect their IP rights in the UK, Europe and worldwide from our offices in the UK and The Netherlands and through our international network of trusted local attorneys.

¹ NDTV, India home to world’s second‑largest diabetes population in 2024: Study, NDTV Health

² For 250 million obese Indians, the weight is finally over, The Times (UK)

³ Reuters, Novo Nordisk patent expiry opens door to cheaper weight‑loss drugs in India, 19 March 2026

⁴ BBC News, Weight‑loss drug prices expected to fall sharply following patent expiry, 18 March 2026

⁵ Pharmacy.biz, Semaglutide patent expiry in India paves the way for generics

⁶ PharmaLive, Semaglutide patent cliff presents substantial opportunity for generics markets