Natco Pharma Files ANDA for Generic Risdiplam, Targeting SMA Treatment Market

Natco Pharma Limited, a Hyderabad-based pharmaceutical giant, announced the submission of an Abbreviated New Drug Application (ANDA) to the US FDA for Risdiplam Oral Solution, the generic version of EVRYSDI® (Risdiplam 0.75 mg/mL). This drug is indicated for treating spinal muscular atrophy (SMA) in both pediatric and adult patients.

Natco Pharma’s ANDA submission includes a Paragraph IV certification, signaling the company’s readiness to challenge the exclusivity of the branded drug in the market.

180-Day Marketing Exclusivity: A Competitive Edge

Natco is among the first two companies to submit a substantially complete ANDA for this product. If successful, this positions Natco for a 180-day shared marketing exclusivity in the US market. This exclusivity period could be a game-changer, as EVRYSDI® recorded sales of $571 million in the United States in 2023.

Legal Challenges on the Horizon

As part of the process, Natco has been named as a defendant in a lawsuit filed in the District Court of New Jersey by Genentech, Hoffmann-La Roche, and PTC Therapeutics. This legal hurdle is a common phase for Paragraph IV certifications, as branded manufacturers seek to protect their intellectual property.

About EVRYSDI® and Its Market Potential

EVRYSDI® is a revolutionary treatment for SMA, a genetic condition that affects motor function. The drug’s significant sales underscore the demand for effective therapies in this domain. By entering this market, Natco Pharma aims to cater to an unmet need while capitalizing on a high-revenue opportunity.

Natco Pharma: An Innovation-Driven Enterprise

Natco Pharma is a leading player in oncology and specialty pharmaceuticals, with a robust presence in the US and 50+ global markets. It operates nine manufacturing facilities and two R&D centers, which are certified by global regulatory authorities like the US FDA, Health Canada, and WHO. The company specializes in limited-competition molecules, underscoring its strategic focus on niche markets.

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