The global pharmaceutical landscape is currently captivated by a high-stakes legal and commercial battle over semaglutide, the blockbuster GLP-1 receptor agonist marketed by Danish giant Novo Nordisk under brand names like Wegovy for weight loss and Ozempic for type 2 diabetes. At the heart of this unfolding drama is a recent patent revocation petition filed by Hyderabad-based Natco Pharma Ltd against Novo Nordisk before the Delhi High Court, challenging the fundamental validity of the innovator’s patent. This legal maneuver is not merely an isolated incident but a pivotal development in a broader struggle that pits multinational pharmaceutical powerhouses against India’s formidable generic drug manufacturers, poised to redefine access and affordability in a rapidly expanding therapeutic area.
On January 6, the Delhi High Court’s single bench, presided over by Justice Jyoti Singh, issued notice to Novo Nordisk, demanding a response within two weeks, signaling the commencement of formal proceedings in this significant intellectual property dispute. A patent revocation petition represents a direct legal assault on an existing patent, arguing for its cancellation on grounds of invalidity, such as lack of novelty, obviousness, or insufficient disclosure at the time of its grant. Should Natco succeed, Novo Nordisk would forfeit its exclusive manufacturing and sales rights for semaglutide in India, opening the floodgates for generic competition well before its scheduled patent expiry in March 2026. This potential outcome carries profound implications, not only for the profitability of a drug projected to generate tens of billions in annual sales globally but also for the future trajectory of healthcare access worldwide.
The current challenge from Natco Pharma is an escalation in a series of legal skirmishes surrounding semaglutide in India. Novo Nordisk has proactively sought to restrain several Indian manufacturers, including industry heavyweights like Sun Pharmaceutical Industries Ltd and Dr Reddy’s Laboratories Ltd, from producing and exporting semaglutide, asserting that such activities constitute an infringement of its patent rights. Prior to this, in August 2025, Natco had initiated its own lawsuit, seeking a declaration that its version of semaglutide did not infringe Novo Nordisk’s device- or process-related patent technology, a matter currently undergoing court-ordered pre-litigation mediation. The complexity of these overlapping legal actions underscores the immense commercial value attached to semaglutide, often hailed as a "wonder drug" for its transformative impact on chronic conditions.
A crucial turning point in this protracted legal saga emerged from a series of rulings by Justice Manmeet Pritam Singh Arora of the Delhi High Court in late 2025, which have significantly bolstered the position of Indian generic manufacturers, particularly concerning export activities. In a landmark decision on December 2, 2025, related to Dr Reddy’s patent revocation case filed in May 2025, the court decisively rejected Novo Nordisk’s plea for an interim injunction against exports. The court reasoned that Novo Nordisk had failed to establish a strong prima facie case for infringement in the context of international sales. This ruling permitted Dr Reddy’s to continue manufacturing and exporting semaglutide to jurisdictions where Novo Nordisk does not hold patent protection, while maintaining a restraint on domestic sales until the patent’s expiry in 2026.
This judicial precedent was swiftly applied on December 10, extending the same principle to Sun Pharmaceutical Industries. Justice Arora’s consistent stance has effectively created a pathway for Indian generic firms to leverage their manufacturing capabilities for global markets even before the complete expiration of innovator patents within India. While Novo Nordisk has since challenged these rulings before a division bench of the Delhi High Court, with appeals slated for hearing later in January, the initial decisions have already ignited optimism within India’s generic industry. The outcome of these appeals will not only determine the immediate export prospects for Dr Reddy’s and Sun Pharma but will also profoundly shape the strategic planning of other Indian companies, including Natco, Cipla Ltd, and Emcure Pharmaceuticals Ltd, as they gear up for generic semaglutide launches post-March 2026.
The litigation unfolds against the backdrop of a burgeoning global market for GLP-1 receptor agonists, driven by the escalating prevalence of type 2 diabetes and obesity worldwide. According to data from Pharmarack, India’s GLP-1 market alone has witnessed an astounding growth trajectory, surging from ₹186 crore in November 2022 to ₹1,047 crore in November 2025—a nearly six-fold increase in just three years. Globally, the GLP-1 market is projected to reach over $100 billion by the end of the decade, with some estimates pushing it towards $200 billion, reflecting the immense patient need and clinical efficacy of these medications. The sheer scale of this market makes the patent landscape a fiercely contested arena, as even a slight shift in market share translates into billions in revenue.
Within the Indian market, the competitive dynamics are intense. Eli Lilly’s tirzepatide, marketed as Mounjaro, launched in March 2025, has rapidly established a dominant position. By October 2025, Mounjaro had already crossed ₹100 crore in monthly sales, capturing approximately 86% of the GLP-1 market by doses. Novo Nordisk’s Wegovy accounts for the majority of the remaining share, illustrating the duopoly currently at play. In response to this aggressive competition and the looming threat of generics, Novo Nordisk has strategically adjusted its pricing for Wegovy in India, a move that has reportedly helped the drug gain approximately five percentage points in absolute doses. Furthermore, Novo Nordisk launched its highly anticipated blockbuster brand Ozempic, specifically indicated for type 2 diabetes, in December, seeking to maximize its monopoly period before the patent exclusivity for semaglutide is fully eroded.
The strategic maneuvers by innovator companies are being met with equally aggressive preparations by Indian generic manufacturers. Firms like Sun Pharma, Dr Reddy’s, and Natco are accelerating their development and regulatory pathways for generic semaglutide versions, aiming for market entry immediately after March 2026. Other Indian pharmaceutical players, such as Cipla Ltd and Emcure Pharmaceuticals Ltd, have opted for alternative strategies, forging distribution partnerships with innovator companies, perhaps to gain a foothold in the GLP-1 segment and learn from existing market players before launching their own products or to diversify their portfolio with branded generics. These diverse approaches highlight the multi-faceted strategies employed to capitalize on a market segment with such explosive growth potential.
The global economic impact of this patent battle extends far beyond corporate balance sheets. Semaglutide and tirzepatide represent significant advancements in addressing chronic diseases that impose a substantial burden on global healthcare systems. Obesity alone affects over a billion people worldwide, contributing to a cascade of comorbidities including diabetes, heart disease, and certain cancers, costing trillions in direct and indirect healthcare expenses annually. The introduction of affordable generic versions of these drugs could revolutionize patient access in developing economies, drastically reducing treatment costs and improving public health outcomes. However, this must be balanced against the need to incentivize innovation, as robust patent protection is often cited as a cornerstone for pharmaceutical research and development. The current legal skirmishes in India, therefore, serve as a microcosm of the global tension between intellectual property rights, public health imperatives, and market competition.
As the Delhi High Court prepares for further hearings, the pharmaceutical world watches intently. The eventual outcome of Natco’s patent revocation petition, combined with the appeals against the export rulings, will not only dictate the immediate fate of semaglutide in India but will also set important precedents for future patent challenges involving high-value drugs. India, often referred to as the "pharmacy of the world," with its robust generic manufacturing capabilities, plays a crucial role in shaping global access to medicines. This legal and commercial frontier for semaglutide will undoubtedly influence how innovation is rewarded, how healthcare costs are managed, and ultimately, how millions of patients around the globe gain access to life-changing therapies.
