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Novo settles US patent challenges with four generic makers

Novo Nordisk settled patent fights with four generic drugmakers in October 2024, locking in US semaglutide exclusivity into the early 2030s even as generics roll out abroad starting in 2026.

By the Semaglutides news desk·

In October 2024, Novo Nordisk settled patent disputes with four generic drugmakers—Mylan Pharmaceuticals (a subsidiary of Viatris), Dr Reddy's, Apotex, and Sun Pharma—over US patent number 10,335,462, which covers specific dosages of semaglutide used to treat type 2 diabetes [1]. The settlements resolved challenges to that patent's validity and, according to industry tracking, preserved Novo Nordisk's exclusive US rights to semaglutide products well into the 2030s [1].

The deal did not close off the rest of the world. In July 2025, Dr Reddy's chief executive Erez Israeli told Reuters, as reported by Pearce IP, that his company plans to launch a generic version of Wegovy in 87 countries in 2026, starting with Canada, India, Brazil, Turkey, and other emerging markets, once patents expire in those regions [1]. Israeli said the United States and Europe will open up later, with "all the other Western markets" becoming available for generic competition "between 2029 to 2033" [1]. He added that Dr Reddy's expects its generic semaglutide to bring in "hundreds of millions of dollars" in sales once it launches broadly [1].

Dr Reddy's is not alone. Other Indian drugmakers, including Cipla, Lupin, Biocon, and Sun Pharma, are also preparing to launch generic weight-loss drugs, following the commercial success of Novo Nordisk's Wegovy and Eli Lilly's Mounjaro (tirzepatide) [1]. Sun Pharma, notably, is both one of the companies that settled with Novo Nordisk over the US patent and one of the companies reportedly eyeing generic versions of GLP-1 obesity drugs for other markets [1].

Why it matters for patients

For people in the United States who take Ozempic, Wegovy, or Rybelsus, this settlement means no lower-cost generic semaglutide is expected in the near term. The patent settlement effectively pushes back the earliest possible date for US generic competition into the 2030s, according to the reporting on patent number 10,335,462 [1]. That means US patients relying on brand-name semaglutide will likely continue facing current list prices and insurance coverage rules for years to come, with no domestic generic pathway confirmed before that window opens [1].

The picture looks different for patients outside the US. If Dr Reddy's and other manufacturers follow through on stated plans, people in countries such as Canada, India, Brazil, and Turkey could see generic semaglutide options as soon as 2026, which may affect pricing and availability for patients in those markets [1]. This creates a gap: emerging markets and some other countries may get lower-cost alternatives years before US patients do, based on the patent timelines described here [1].

It's not yet known exactly how the staggered timeline will affect list prices, insurance coverage, or supply in the United States specifically, since the sources describe patent settlement dates and international launch plans but do not detail US pricing outcomes [1]. Patients should not assume any near-term change in US semaglutide costs or availability based on this settlement alone.

What happens next

Dr Reddy's has said it plans generic launches in 87 countries starting in 2026, with Canada, India, Brazil, and Turkey among the first markets [1]. The company's CEO has stated that US and European markets are expected to open to generic competition sometime between 2029 and 2033, following the terms of the October 2024 patent settlements [1]. No specific US launch date for generic semaglutide has been confirmed in the sources reviewed here.

Sources

  1. https://www.pearceip.law/2025/07/24/dr-reddys-plans-to-launch-generic-semaglutide-in-87-countries-in-2026

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