Natco Pharma’s attempt to launch an affordable generic of the rare-disease drug Risdiplam shakes up India’s pharma landscape—only to hit a legal wall.

Natco Pharma has announced plans to introduce a generic version of Risdiplam, a drug used to treat spinal muscular atrophy (SMA), at Rs 15,900 per bottle. However, the product launch has been delayed due to an ongoing legal case.

According to an official statement from the NATCO Pharma website, the company received several enquiries from investors and patients regarding the drug’s availability and pricing. Risdiplam, sold under the brand Evrysdi by Roche, currently costs around Rs 6.2 lakh per bottle. Natco’s version, if launched, would reduce the cost to approximately Rs 30,000 per month, as each bottle lasts about 12 days.

The legal issue began when Natco challenged Roche’s patent on Risdiplam in India. In March 2025, the Delhi High Court’s single-judge bench denied Roche’s request to stop Natco from launching the product. However, Roche later appealed the decision. The Appellate Bench of the Delhi High Court has now directed both parties to maintain the status quo, which has put the product launch on hold.

Due to the ongoing court proceedings, Natco has decided not to comment further. The company stated that it would only move forward with the launch if the Appellate Bench ruled in its favour. In line with its earlier stand in court, Natco also said it plans to offer discounts to eligible patients through a patient access programme once the product is available.

The case is being closely watched in the pharmaceutical industry because it could affect pricing and access to treatment for rare diseases in India.