NATCO Pharma Limited today announced a significant legal victory, confirming its ability to immediately launch a generic version of the critical drug Risdiplam in the Indian market.
In a landmark decision, the Commercial Appellate Division of the Hon’ble Delhi High Court dismissed an appeal filed by the Swiss Pharmaceutical Company F. Hoffmann-La Roche AG (Roche).
This ruling removes the final hurdle preventing NATCO from launching an affordable, life-saving version of the medication.
The drug, Risdiplam, is used to treat Spinal Muscular Atrophy (SMA). SMA is a debilitating disease and is one of the leading causes of death in infants, stemming from the degeneration of neurons.
Currently, curative treatment options for SMA are limited and often financially inaccessible to the majority of Indian patients.
The legal battle centered on NATCO’s ability to launch its generic version. Earlier this year, on 24 March 2025, a Single Judge of the Hon’ble Delhi High Court had paved the way for NATCO, denying Roche’s plea for an injunction against the company.
The Single Judge emphasized the public interest involved, noting that Roche’s original pricing had rendered the drug unaffordable and inaccessible to most patients. The court also factored in the challenge to the invalidity of Roche’s patent.
Roche subsequently filed an appeal, but the appellate Bench of the Delhi High Court announced today, 9 October 2025, that the appeal was refused.
The Division Bench’s decision to dismiss the appeal is considered a “first of its kind” ruling in allowing a life-saving drug like Risdiplam to be made accessible at an affordable price. The status quo has consequently been removed.
Following the ruling, NATCO has decided to launch the product with immediate effect. The company confirmed it will price the generic version at INR 15,900 MRP, consistent with the stand it took before the court.
Furthermore, NATCO intends to offer certain discounts to deserving patients through its patient access programme.
NATCO Pharma Limited, headquartered in Hyderabad, India, develops, manufactures, and distributes generic and branded pharmaceuticals, focusing on R&D and specializing as a leading oncology player in the domestic market.
This intimation was signed by Ch. Venkat Ramesh, Company Secretary & Compliance Officer.
The disclosure was made under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
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जो व्यक्ति सुख-दुःख की परिस्थितियों में भी समान भाव रखता है, वही सच्चा ज्ञानी है। उसकी शांति और धैर्य उसे मोक्ष की ओर ले जाते हैं।
Those who remain balanced in happiness and distress, unaffected by dualities, are true seekers of wisdom. Their calmness and patience lead them toward liberation.
