The Delhi High Court has directed Sun Pharma to seek court approval before launching its oral semaglutide tablets. This follows a lawsuit from Novo Nordisk, which alleges that the company’s formulation infringes on its patent for a key absorption enhancer.
The Delhi High Court has issued an interim order that restricts Sun Pharmaceutical Industries from launching its semaglutide tablets in India without first obtaining judicial clearance. This development creates a significant legal hurdle for the pharmaceutical company as it attempts to expand its presence in the high-growth diabetes and weight-loss medication market.
The court's decision follows a patent infringement lawsuit filed by the Danish pharmaceutical firm Novo Nordisk. Novo Nordisk, which owns the intellectual property for widely known semaglutide drugs like Ozempic and Wegovy, claims that Sun Pharma's proposed oral version of the drug uses a specific ingredient that violates its patent. This ingredient is known as Salcaprozate sodium, or SNAC, which acts as an absorption enhancer, allowing the drug to be taken orally rather than via injection.
Under the court's directive, Sun Pharma is required to file an application with the court once it receives a commercial manufacturing license for the product. Only after this step will the court decide whether the company can proceed with its market launch. This legal safeguard is intended to protect the interests of the innovator while the patent dispute undergoes a formal review.
For investors, the primary monitorable is how this litigation affects Sun Pharma's product pipeline in the chronic care segment. The diabetes and obesity treatment space has seen rising competition, with various domestic players attempting to introduce generic versions of semaglutide. Novo Nordisk is aggressively defending its intellectual property rights and has initiated similar legal actions against other manufacturers, including Torrent Pharmaceuticals.
While Sun Pharma has received preliminary approval from the Subject Expert Committee of the Central Drugs Standard Control Organisation, the legal challenge introduces uncertainty regarding the timing and viability of the product launch. The dispute highlights the challenges generic manufacturers face when developing complex oral formulations that rely on specialized absorption technologies.
The next steps in this matter will center on upcoming court hearings where the validity of the SNAC patent claims will be examined. Investors should keep track of whether the company secures its final manufacturing license and how the court responds to the subsequent application to launch, as these updates will determine if and when the product can reach the Indian market.