India Pharma Outlook Team | Friday, 10 October 2025
In a significant relief for Natco Pharma, a bench of the Delhi High Court presided by Justice Hari Shankar has vacated its previous order restraining the company from launching the generic version of Risdiplam.
Risdiplam an oral drug for the treatment of spinal muscular atrophy (SMA) in patients aged two months and older.
The order in March stemmed from an appeal by Roche, a Swiss drugmaker and patent holder of a “species patent” for Risdiplam — the pharmaceutical active ingredient in its branded medicine Evrysdi, which is marketed in India at roughly ?6 lakh per bottle.
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In the wake of the latest verdict, Natco Pharma of Hyderabad announced the launch of its locally manufactured generic Risdiplam at ?15,900 per bottle, immediately — approximately 80–90% below the price of Roche’s version. The company added that additional discounts would be extended to ensure affordability for deserving patients through its patient access programme.
The spokesperson for Roche Pharma India expressed disappointment with the ruling and noted the company is examining its legal options under Indian law. Roche added, “Intellectual property protection for pharmaceutical innovation and access to new medicines remains an important issue in India.”
Roche emphasized that since the 2021 launch of Evrysdi in India the company has partnered with authorities to provide access, and that it also established a Compassionate Use Program that provided free access to Evrysdi for 52 patients, and a total of about 300 patients. In March, Justice Mini Pushkarna denied Roche's request for interim relief, indicating that access to affordable treatment for a rare disease is an important public interest factor.
