In a landmark decision with far-reaching consequences for India's pharmaceutical sector, the Delhi High Court has granted Dr Reddy's Laboratories permission to manufacture and export its generic version of the weight-loss drug semaglutide. The ruling, delivered on Tuesday, allows exports to countries where the original patent holder, Danish firm Novo Nordisk, does not hold patent protection.
A Legal Victory for Generic Drugmakers
Justice Manmeet Singh Arora's single-judge bench found prima facie merit in Dr Reddy's petition challenging the validity of Novo Nordisk's secondary patent on semaglutide's formulation. This patent, covering delivery mechanisms for improved stability, is valid until March 2026. Lawyers familiar with the case, who spoke on condition of anonymity, confirmed that the court's recognition of this merit formed the basis for denying interim relief to Novo Nordisk.
The court's order, the detailed written version of which was awaited at press time, explicitly permits Dr Reddy's to produce semaglutide domestically and ship it to non-patent markets. However, a crucial restriction remains: the company cannot export to countries where Novo's patent expires in March 2026 until that month arrives. Similarly, the ban on domestic sales in India, where the patent also lapses in March 2026, stays in effect.
The Patent Battle and Market Implications
The legal tussle centers on Novo Nordisk's patent strategy for semaglutide, the active compound behind its blockbuster drugs Ozempic and Wegovy. While the primary composition patent expired in September 2024, the company holds a secondary formulation patent. Dr Reddy's has challenged this under Section 64 of the Patents Act, labeling it an attempt at "evergreening" to extend monopoly control.
This development is a significant signal for India's generic pharmaceutical industry, which is eager to capitalize on the rapidly expanding global market for anti-obesity medications. Following the patent's expiry, several major Indian drugmakers, including Sun Pharma, Mankind Pharma, and Natco Pharma, alongside Dr Reddy's, plan to launch more affordable generic versions.
Novo Nordisk, anticipating the competitive landscape, has already partnered with Pune-based Emcure Pharmaceuticals to distribute its drug under the brand Poviztra in India, aiming to expand its reach beyond metropolitan areas.
Background of the Legal Dispute
The conflict escalated when Dr Reddy's, after securing regulatory approval in December 2024 to manufacture semaglutide solely for export, invoked India's Bolar exemption (Section 107A). This provision allows the export of patented drugs to countries where patents have expired. Novo Nordisk countered, citing Section 48, which grants patent holders exclusive rights.
The legal timeline saw Dr Reddy's challenge the patent's validity in May, followed swiftly by a patent infringement suit from Novo. An interim order in late May barred domestic sales but allowed export. After appeals and clarifications, the matter was sent back to a single bench, leading to Tuesday's ruling that upholds the export allowance until March.
In a related development, Natco Pharma filed a separate non-infringement suit in August, claiming its version does not violate Novo's patents. That matter is currently under mediation.
The Semaglutide Phenomenon and Indian Market Dynamics
Semaglutide, a GLP-1 receptor agonist, mimics a hormone that signals fullness to the brain. Originally for type-2 diabetes, its efficacy in weight management—showing 15-23% body weight reduction—has made it a global phenomenon.
The Indian anti-obesity drug market has witnessed explosive growth, skyrocketing from ₹133 crore in March 2021 to ₹576 crore in March 2025, with semaglutide alone contributing approximately ₹397 crore, as per PharmaTrac data.
The market is currently dominated by Novo's semaglutide range and Eli Lilly's tirzepatide (Mounjaro). In a telling shift, Mounjaro overtook Wegovy in October 2024, recording monthly sales of ₹100 crore—nearly ten times Wegovy's revenue, according to Pharmarack. In response to this intense competition, Novo Nordisk slashed Wegovy's price by 37% in November, reducing the entry-level dose cost to ₹10,850 per month.
The Delhi High Court's decision thus sets the stage for a transformative phase in India's pharmaceutical exports, potentially positioning the country as a key supplier of affordable anti-obesity treatments to the world.
