- Sun Pharma must get court approval before launching its semaglutide tablets in India
- Delhi High Court order follows patent suit by Novo Nordisk against Sun Pharma
- Court seeks detailed info on SNAC content in Sun Pharma’s proposed semaglutide tablets
Sun Pharmaceutical Industries has suffered a legal setback in its plans to introduce an oral diabetes and weight-management drug, with the Delhi High Court directing the company to seek explicit court approval before launching its semaglutide tablets.
The judicial directive stems from a patent infringement suit filed by Danish drugmaker Novo Nordisk, which alleges that Sun Pharma's proposed generic tablets violate its existing patents. The ongoing legal dispute specifically revolves around Sun Pharma's planned 3 mg, 7 mg, and 14 mg semaglutide oral tablets.
During the proceedings, the High Court flagged ambiguity regarding the precise composition of Sun Pharma's proposed tablets. To properly evaluate Novo Nordisk's patent claims, the court has sought detailed information regarding the SNAC content in the generic drug. SNAC is a critical agent that helps semaglutide tablets get absorbed through the stomach.
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The court emphasised on thoroughly examining the product details before permitting any commercial rollout.
Defending the company's position, Sun Pharma's counsel argued that the potential oral product does not violate Novo Nordisk's patent rights. The counsel also informed the court that Sun Pharma has not yet secured a commercial manufacturing license for the semaglutide tablets in question.
Until the product details are reviewed and legal clearance is granted, the pharma major remains strictly bound to obtain the High Court's permission prior to any commercial launch.
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