Natco Pharma cleared to launch generic Risdiplam in India

Natco Pharma Limited announced on October 9, 2025, that the Commercial Appellate Division of the Delhi High Court dismissed an appeal filed by F. Hoffmann-La Roche AG. This decision upholds an earlier judgment from March 24, 2025, which had denied Roche's injunction plea, thereby clearing the way for Natco to launch its generic version of Risdiplam.

Risdiplam is a crucial drug for treating Spinal Muscular Atrophy (SMA), a severe neurological disease. The court emphasized public interest, noting that Roche's pricing made the drug inaccessible and unaffordable for many Indian patients. Natco Pharma plans to launch the product immediately at an MRP of INR 15,900 and will also offer discounts through a patient access program.

The company, headquartered in Hyderabad, India, develops, manufactures, and distributes generic and branded pharmaceuticals. Natco Pharma operates nine manufacturing sites and two R&D facilities in India, with facilities approved by global regulatory authorities including the US FDA and Health Canada.