Phenol

New Delhi: What innovation's greatest risks and rewards look like is precisely what the Semaglutide story represents today, a blockbuster GLP-1 molecule that redefined diabetes, obesity care across geographies, and labelled as the bedrock for Novo Nordisk , and a crown jewel of Denmark’s economy. From climbing to the top of Wall Street to witnessing a $90 billion drop within a week, Novo Nordisk Semaglutide stint has been full of swings and swirls—now bracing to pass the baton to its generic offsprings. However as the molecule nears the end of its patent protection in India , a series of legal twists are peeling back nuances in Semaglutide’s complex patent web. Speaking to ETPharma Apoorva Murali, Partner, Shardul Amarchand Mangaldas & Co, said that, "the core composition patent of Semaglutide will expire on March 20, 2026. However, recent pharmaceutical patent disputes have demonstrated that a drug may be covered by both genus and species patents which creates a complex legal scenario regarding patent exclusivity.” In the case of Semaglutide, the genus patent (which covers the broad group of related compounds) expired in September 2024, and the formulation protection (species patent)— targeted by the generic drugmakers -- will expire next year. Confirming the proposed timeline a Novo Nordisk spokesperson in an email response to ETPharma queries said that, “the core composition patent for Semaglutide expires in the first half of 2026, with additional formulation and device patents following different timelines.” However Murali also suggest that, the patentee (Novo Nordisk) appears to have a PCT application pending decision before the Indian Patent Office , for a liquid composition of Semaglutide and is also appears to have become a subject matter of dispute in the ongoing litigation before the Delhi High Court. While refraining from commenting on the litigation, the company spokesperson said, “we believe that the strong trust, familiarity with our high-quality products, combined with the significant investments in scaling our manufacturing capacity and supply of Semaglutide, will allow us to treat more patients in the coming years.” A Patent Cooperation Treaty administered by the World Intellectual Property Organization (WIPO), allows innovators to seek patent protection for their inventions in multiple countries through a single application. According to details available on the Indian Patent Office website accessed by ETPharma, Novo Nordisk has filed PCT application under no. ‘202047010224’ seeking a patent for a “liquid composition of Semaglutide containing no more than 0.01 per cent phenol with water (w/w)” Phenol is a common stabilizing agent across several medicines which are administered via injection. It helps to improve the stability and tolerance of medicines but may lead to irritation especially among sensitive patients. According to a prescription document submitted by the drugmaker to the US FDA , “1 ml of Ozempic solution (a type-2 diabetes brand of Semaglutide) contains 5.5 mg phenol and water for injections.” However the pending application does not debar the entry of generics which are primarily targeting the formulations with a higher phenol concentration. Besides the formulations the Danish drugmaker also holds a specific patent for its delivery device designed to enable self-administration of metered doses. Novo Nordisk branded formulations are marketed with a single-patient-use prefilled pen which contains four fixed doses, administered once weekly and this exclusivity is also expected to complete its lifecycle by early next year. Commenting on the device, the company spokesperson said that replicating Novo Nordisk’s pen device technology would be a significant challenge for generic players, given the expertise, regulatory standards, and patient-centric design involved. Notably, the drug has also secured an expanded approval for an additional indication called metabolic-associated steatohepatitis (MASH) in the US. While drugmakers in India are vying for the obesity and weight-loss market, the FDA approval gives Novo Nordisk room to seek expanded approval in India — and potentially, market exclusivity as well. “We are engaging with regulators worldwide, including in India, to evaluate potential pathways to ensure people living with MASH have access to this medication,” the company spokesperson said. Meanwhile, on extending exclusivity Murali noted that going with the past evidence it is possible for patentees to attempt to extend market exclusivity by seeking patent protection for new formulations, provided they justify the “novelty, inventiveness and enhanced efficacy” of the claimed subject matter. Global Outlook Alongside India, generic aspirants are gearing to explore the LOE window opening in several other key markets, including Canada and Brazil, as they seek to expand their opportunities. For Canada Murali highlighted, “the patentee’s (Novo Nordisk) main Semaglutide patent lapsed in 2020 due to non-payment of a maintenance fee, years before its scheduled expiry in March 2026 and at present, there are no reported pending litigations. In Brazil she noted that, “the requests for patent term extensions were rejected by a regional court and thereby the formulation will lose its exclusivity as scheduled in 2026.” Expected green light for generics As several drugmakers are looking to leverage the LOE (loss of exclusivity) window in the first wave, IP experts suggest that the ongoing disputes are unlikely to hinder the launches, given that India’s regulatory and patent frameworks function separately, unlike the patent linkage systems in other regulated markets. “Regulatory approval by the CDSCO is independent of patent status, and obtaining a marketing license does not eliminate the possibility of a patent infringement claim,” Murali said Meanwhile the Bolar exemption under the Patents Act allows the use of a patented invention without the patentee's consent for research purposes. Having failed to capitalize on its innovative success with first movers advantage in India’s GLP-1 injectable space— left with a multi-layered protection, and further pending approvals Novo Nordisk seems unwilling to cede an easy victory to generics over a molecule that forms the backbone of its balance sheets. By Abhijeet Singh ,