NATCO Pharma Wins Legal Battle Against Roche to Launch Affordable Risdiplam for Spinal Muscular Atrophy in India

NATCO Pharma Limited announced a major legal victory in its ongoing patent dispute with pharmaceutical giant Roche. The Commercial Appellate Division of the Hon’ble Delhi High Court dismissed an appeal filed by Roche, thereby upholding an earlier court order dated March 24, 2025, which had denied Roche’s request for an injunction against NATCO.

This decision grants NATCO the legal authority to proceed with the commercial launch of its generic version of Risdiplam in India without restriction at this stage.

Legal Background: The Appellate Division upheld the initial ruling, which found no sufficient grounds to restrain NATCO from entering the market, classifying the decision as a landmark step toward promoting patient access to essential medicines.

Significant Price Reduction and Patient Access

The introduction of NATCO’s generic Risdiplam is expected to drastically reduce the financial burden on patients and families dealing with Spinal Muscular Atrophy (SMA).

Maximum Retail Price (MRP): NATCO plans to launch the medicine in India at an MRP of ₹15,900.
Patient Access Programme: In addition to the low MRP, the company has announced a patient access programme to provide further discounts for eligible patients, aiming to improve accessibility to the high-cost, life-saving therapy.

About Risdiplam and Spinal Muscular Atrophy (SMA)

Risdiplam is an oral therapy originally developed and marketed globally by Roche under the brand name Evrysdi.

Condition: It treats Spinal Muscular Atrophy (SMA), a rare, progressive genetic disorder that severely affects muscle strength and motor function.
Impact: SMA primarily affects infants and young children and, if left untreated, often leads to severe disability or death. The availability of an affordable, generic oral treatment is seen as a critical development in Indian healthcare.

This move aligns with NATCO Pharma’s historical focus on engaging in patent litigation to improve access to affordable, high-cost, life-saving medicines, particularly in the oncology and rare diseases segments.