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USFDA Grants Tentative Approval with Exclusivity
Granules India Ltd.'s U.S. subsidiary has received tentative approval from the U.S. Food and Drug Administration (USFDA) for a generic treatment for attention deficit hyperactivity disorder (ADHD). The approval comes with a significant 180-day period of market exclusivity, a key advantage for the pharmaceutical company.
Strategic Win for Complex Generics
The approval is for Granules Pharmaceuticals Inc.'s abbreviated new drug application for generic Amphetamine Extended-Release Tablets in 5mg, 10mg, 15mg, and 20mg strengths. This product is the generic equivalent of DYANAVEL XR and targets an estimated market size of approximately $41 million. Separately, the company had received tentative approval on December 22 for generic Amphetamine Extended-Release Orally Disintegrating Tablets, the equivalent of ADZENYS XR-ODT, addressing a market of $172 million with only one other approved generic and one authorized generic.
Market Reaction and Company Outlook
Despite the positive regulatory development, shares of Granules India traded little changed at ₹611.9 on Thursday, January 8. The stock has remained flat over the past 12 months. Chairman and Managing Director Krishna Prasad Chigurupati highlighted that securing a product eligible for 180-day exclusivity validates the company's strategy in building a complex generics portfolio.