NATCO Pharma Limited has announced a significant legal victory in its ongoing patent dispute with Roche, enabling the company to launch its generic version of Risdiplam, a drug used in the treatment of Spinal Muscular Atrophy (SMA), in India.
In a regulatory filing with the BSE dated October 9, 2025, NATCO informed that the Commercial Appellate Division of the Hon’ble Delhi High Court has dismissed Roche’s appeal against an earlier court order dated March 24, 2025, which had denied Roche’s plea for an injunction against NATCO. With this decision, NATCO is now legally permitted to market its version of Risdiplam in India.
The company stated that the Commercial Appellate Division upheld the previous ruling of the Delhi High Court, which had refused to restrain NATCO from launching the product. The earlier order had found no grounds to grant an interim injunction in favor of Roche. This dismissal of Roche’s appeal effectively allows NATCO to proceed with the commercial launch of its generic Risdiplam without legal restriction at this stage.
As per the filing, NATCO plans to launch the medicine at a Maximum Retail Price (MRP) of ₹15,900 in India. In addition, the company has announced a patient access programme to provide further discounts for eligible patients, thereby improving accessibility for those affected by Spinal Muscular Atrophy.
The company described the development as a landmark decision that promotes affordability and patient access to essential medicines in India.
Risdiplam is an oral therapy indicated for the treatment of Spinal Muscular Atrophy (SMA), a rare and progressive genetic disorder that affects muscle strength and motor function. The drug was originally developed and marketed globally by Roche under the brand name Evrysdi. SMA primarily affects infants and young children and, without treatment, can lead to severe disability or even death. The introduction of a lower-cost generic version is expected to significantly reduce the financial burden on patients and families in India.
NATCO Pharma has a history of engaging in patent litigation related to high-cost, life-saving medicines. The company has consistently focused on improving access to affordable medicines, with a strong presence in oncology and treatments for rare diseases.
This latest judgment further reinforces the role of Indian courts in balancing intellectual property rights with public health interests, especially in cases involving essential or rare-disease treatments.
