• Title: Natco Pharma Set to Offer Affordable Risdiplam for Spinal Muscular Atrophy at ₹15,900 Amid Ongoing Legal Challenges

• Content:

Natco Pharma, a notable player in the Indian pharmaceutical sector, has announced plans to launch a generic version of the drug Risdiplam, aimed at treating spinal muscular atrophy (SMA), at a highly competitive price of ₹15,900 per bottle. This pricing strategy represents a dramatic reduction from Roche's branded product, Evrysdi, which currently costs around ₹6.2 lakh per bottle. However, legal complications have temporarily stalled the launch, leaving patients and investors eagerly awaiting developments in this pivotal case.

Understanding Spinal Muscular Atrophy and Risdiplam

What is Spinal Muscular Atrophy?

Spinal muscular atrophy is a rare genetic disorder characterized by the degeneration of motor neurons in the spinal cord, leading to muscle wasting and weakness. The disease significantly impacts the quality of life of affected individuals, with the potential for severe complications. Risdiplam, initially marketed as Evrysdi by Roche, stands as one of the few treatment options available for this debilitating condition.

Risdiplam's Cost and Accessibility Issues

Currently, the exorbitant price of Roche's Evrysdi leaves many patients facing financial hardship, as the drug is not only crucial but also outside the reach of many families. The cost per month stands at approximately ₹30,000, as each bottle lasts approximately 12 days. Natco's promise to sell a generic equivalent at ₹15,900 is a significant development aimed at enhancing accessibility to treatment for SMA sufferers in India.

Legal Hurdles and Path Forward

Current Legal Situation

Natco has been embroiled in a legal battle with Roche concerning the patent rights for Risdiplam, which Roche claims to hold until May 2035. The Delhi High Court's initial ruling in March 2025 allowed Natco to proceed with manufacturing the drug, emphasizing public interest and the need for affordable treatment options. Justice Mini Pushkarna noted that the high cost of Roche’s drug was untenable, particularly given the government’s concerns about supporting rare disease treatments financially.

Despite this win for Natco, Roche appealed the decision, leading to the Appellate Bench of the Delhi High Court ordering both parties to maintain the status quo. This legal entanglement has delayed Natco's plans to bring the much-needed medication to market.

Implications for Patients and the Healthcare Landscape

The ongoing case is being closely monitored as it has far-reaching implications not only for SMA patients but also for the broader pharmaceutical industry landscape in India. A successful launch of Natco's generic Risdiplam could set a precedent for future generic drug introductions in the wake of expensive patented medications, potentially redefining how rare disease treatments are priced and accessed.

Natco's Commitment to Patient Access

Even amid legal uncertainties, Natco has pledged to implement a patient access program that will offer discounts to eligible patients once the drug becomes available. The company is aware of the critical nature of this medication for SMA patients, and aiding those in financial need has become a central tenet of its business strategy.

Key Features of Natco's Risdiplam Offering

• Price Point: ₹15,900 per bottle, significantly lower than Roche's ₹6.2 lakh.

• Treatment Duration: Each bottle lasts approximately 12 days, equating to a monthly treatment cost around ₹30,000.

• Patient Assistance Program: Discounts available for deserving patients to improve drug accessibility post-launch.

The Bigger Picture: Rare Disease Drug Accessibility in India

The case surrounding Risdiplam’s patent and pricing reflects a larger issue regarding the accessibility of rare disease treatments in India. As the healthcare landscape evolves, the need for affordable and effective treatment options for rare diseases has become increasingly apparent. The success of Natco's generic offering could pave the way for a shift in how rare diseases are treated in India, potentially increasing pressure on multinational pharmaceutical companies to reconsider pricing strategies.

Conclusion

The anticipated launch of Natco's generic Risdiplam encapsulates both a beacon of hope for SMA patients burdened by the high cost of treatment and a contested legal battleground that could reshape the Indian pharmaceutical market. As both Natco and Roche await the Delhi High Court's ruling, the future of affordable healthcare access for rare diseases hangs in the balance. For now, patients and families with SMA remain hopeful that a more accessible treatment option will soon become a reality.

As Natco Pharma navigates the complexities of patent law and seeks to deliver affordable healthcare solutions, the path forward remains fraught with challenges but also ripe with opportunity. The outcome of this legal tussle will be pivotal not just for Natco and Roche but for the thousands of individuals seeking effective treatments for rare diseases across India.

In summary, Natco's efforts to introduce Risdiplam at ₹15,900 could represent a transformative step in ensuring that effective treatments for debilitating conditions like SMA are within reach for all patients, establishing a new standard for drug pricing and accessibility in India.