Natco Pharma has achieved a significant legal triumph, enabling the launch of a generic version of Risdiplam, a critical treatment for spinal muscular atrophy (SMA), in India.
The Delhi High Court dismissed an appeal by Swiss pharmaceutical company Roche, clearing the final legal hurdle for Natco’s market entry.
The court’s decision upholds a March 2025 ruling by a single-judge bench, which had denied Roche’s request for an injunction against Natco’s sale of the drug.
The bench emphasized public interest, noting that SMA is a rare and severe genetic disorder with limited treatment options in India.
The ruling highlighted the need for affordable access to life-saving therapies, considering the high cost of Roche’s branded version, Evrysdi.
Following the court’s decision, Natco Pharma announced the immediate launch of its generic Risdiplam at a maximum retail price (MRP) of ₹15,900 per bottle, a significant reduction from the approximately ₹6.2 lakh charged for Roche’s branded product.
The company also plans to offer additional discounts to eligible patients through its patient access program.
This development has been welcomed by patient advocacy groups, who view it as a step toward improving access to essential medicines for rare diseases in India.
The Working Group on Access to Medicines and Treatment commended the court’s decision, emphasizing the importance of prioritizing public health over patent rights in cases involving life-saving treatments.
Natco Pharma’s stock experienced a notable increase following the court’s ruling, reflecting investor confidence in the company’s prospects.
The launch of the affordable generic Risdiplam is expected to have a positive impact on Natco’s market position and contribute to broader efforts to enhance access to healthcare in India.