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09/10/2025 18:26

NATCO Pharma cleared to Launch Generic Risdiplam in India Following Landmark Delhi HC Ruling

NATCO Pharma Limited announced a major legal victory enabling the launch of its generic version of Risdiplam, a drug used to treat Spinal Muscular Atrophy (SMA), a debilitating and often fatal disease in infants.

The decision follows the dismissal of an appeal by F. Hoffmann-La Roche AG by the Commercial Appellate Division of the Delhi High Court on October 9, 2025. Earlier, a Single Judge of the Delhi High Court, in a landmark judgment dated March 24, 2025, had denied Roche’s plea for an injunction against NATCO, considering the patent’s invalidity and emphasizing public interest, given the high pricing of the drug by Roche that made it largely inaccessible in India.

With the Division Bench now refusing Roche’s appeal, the final legal hurdle has been removed, allowing NATCO to make the lifesaving drug available at an affordable price of INR 15,900 MRP. The company also plans to extend additional discounts through its patient access program for deserving patients.

This development marks a significant step in improving accessibility to critical treatment for SMA patients in India, offering hope to countless families affected by the disease.