In a significant legal move within the Indian pharmaceutical sector, Natco Pharma Ltd has approached the Delhi High Court seeking the revocation of Danish drugmaker Novo Nordisk's patent for semaglutide, a crucial medication used for managing Type-2 Diabetes. This action follows a similar suit filed earlier by Dr Reddy's Laboratories (DRL), intensifying the legal battle over the blockbuster drug in India.
Delhi High Court Takes Up the Case
Justice Jyoti Singh of the Delhi High Court issued a formal notice to Novo Nordisk on Tuesday, directing the company to respond to Natco Pharma's legal challenge. The court has scheduled the next hearing in this matter for February 5. Natco's legal counsel, Senior Advocate J Sai Deepak, argued that the company holds a stronger position than other Indian manufacturers because it approached the court before starting any production of the drug, a strategic pre-emptive move.
This lawsuit is the latest development in a series of patent disputes surrounding semaglutide in India. Last year, Dr Reddy's Laboratories initiated proceedings under the Patents Act and the Commercial Courts Act, seeking to invalidate the Indian patent numbered 'IN 262697' held by Novo Nordisk. In a pivotal December ruling, the Delhi High Court preliminarily found that DRL had presented a credible challenge to the validity of Novo Nordisk's patent.
The Semaglutide Patent Landscape in India
Novo Nordisk's semaglutide products, most notably the brand Ozempic, are protected by two primary Indian patents. The first, Indian Patent No. 275964, covered the core composition of semaglutide. This patent was filed in March 2006 and expired in September 2024, opening avenues for generic drug development.
The patent currently under challenge is Indian Patent No. 262697. It pertains to specific formulations and delivery devices designed to enhance the drug's stability and administration. Filed in March 2007, this patent is officially set to expire in March 2026. Novo Nordisk launched Ozempic in the Indian market in December of last year.
The legal landscape is crowded, with Novo Nordisk also pursuing patent infringement suits in the Delhi High Court against several other Indian pharmaceutical majors, including Alkem Laboratories, Sun Pharmaceuticals, and Zydus Lifesciences, alongside DRL.
Export Allowed, Domestic Sales Barred
In the ongoing case involving DRL, the court has adopted a nuanced position. While it has not explicitly prohibited Indian companies from manufacturing semaglutide, it has restrained them from selling the drug within India until the patent expires. This ruling leaves Indian manufacturers with the option to export their generic versions to countries where Novo Nordisk does not hold patent protection, such as Canada.
Meanwhile, DRL has escalated its legal offensive by formally requesting the court to revoke Novo Nordisk's patent entirely, a move now mirrored by Natco Pharma.
The timing of Natco's suit is critical, coinciding with the recent launch of Ozempic in India and the impending patent expiry. It signals a fierce race among domestic drugmakers to establish a foothold in the future generic market for semaglutide. Notably, in October 2025, Natco Pharma informed Indian stock exchanges that its partner, Mylan Pharmaceuticals Inc., had reached a confidential settlement with Novo Nordisk in US patent litigation over Ozempic, with both firms collaborating on generic development.
Beyond its primary use for Type-2 diabetes, semaglutide formulations have gained global popularity as weight-loss treatments and are now available in both injectable and pill forms in various international markets.
