Novo Nordisk settles US semaglutide patent disputes with four generic makers
The settlements keep generic semaglutide out of the US for now, while generic versions head to dozens of other countries starting in 2026.
Novo Nordisk settled US patent disputes with four generic drugmakers in October 2024 over a patent that covers specific doses of semaglutide used to treat type 2 diabetes, an agreement that leaves the US market closed to those generics while much of the rest of the world opens up [1].
The four companies were Mylan Pharmaceuticals, a subsidiary of Viatris, Dr Reddy's, Apotex and Sun Pharma. Each settled with Novo Nordisk in October 2024, ending a dispute over the validity of US patent no. 10,335,462, which covers specific dosages of semaglutide used to treat type 2 diabetes [1]. Semaglutide is the active ingredient in Novo Nordisk's Wegovy [1]. The terms of the settlements have not been reported.
In late July 2025, Reuters reported that Dr Reddy's CEO Erez Israeli said his company plans to launch its generic version of Wegovy in 87 countries in 2026, beginning with Canada, India, Brazil, Turkey and other emerging markets, subject to patent expiry [1]. Israeli said the "U.S. and Europe will open later… (and) all the other Western markets will be open between 2029 to 2033," and that he expects the generic to generate "hundreds of millions of dollars" in sales [1].
Dr Reddy's is not alone. According to Reuters, other Indian drugmakers, including Cipla, Lupin, Biocon and Sun Pharma, also plan to launch generic weight-loss drugs [1]. Sun Pharma is one of the four companies that settled with Novo Nordisk in the US case [1].
Why it matters for patients
Where a person lives will shape when generic semaglutide reaches them. Based on the plans Israeli described, patients in Canada, India, Brazil and Turkey could see generic versions in 2026, while patients in the US would wait longer [1]. Israeli put other Western markets between 2029 and 2033, with the US and Europe opening later than that, though he did not give dates for those two markets [1].
The US picture depends partly on what the patent at issue actually covers. Patent no. 10,335,462 covers specific dosages of semaglutide used to treat type 2 diabetes, not every semaglutide product or use [1]. The settlements ended the challenges those four companies brought against that patent, so no US court ruling on its validity was issued [1].
Whether generic competition will change what US patients pay, or how supplies of branded semaglutide will be affected, has not been reported. Neither Novo Nordisk nor the settling companies disclosed financial terms, and no US launch dates for generic semaglutide have been announced [1].
What happens next
- 2026: Dr Reddy's plans to launch generic semaglutide in 87 countries, starting with Canada, India, Brazil and Turkey, subject to patent expiry [1].
- 2029 to 2033: Other Western markets are expected to open in that window, according to Israeli [1].
- US and Europe: Israeli said both "will open later." No specific dates for either market have been reported [1].
Sources
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