Granules Pharmaceuticals Receives FDA Tentative Approval with 180-Day Exclusivity for Generic gDYANAVEL XR Tablets
Mumbai: Granules Pharmaceuticals, Inc., a wholly owned subsidiary of Granules India Limited, has received Tentative Approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Amphetamine Extended-Release Tablets, the generic equivalent of DYANAVEL XR®.
The tentative approval covers tablet strengths of 5 mg, 10 mg, 15 mg, and 20 mg. The FDA has determined the ANDA to be eligible for 180-day exclusivity, underscoring Granules’ expanding capabilities in developing and commercialising complex and differentiated generic products for the U.S. market.
The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and has an estimated market size of approximately USD 41 million.
Granules Pharmaceuticals, Inc. had earlier received tentative approval on December 22, 2025, for Amphetamine Extended-Release Orally Disintegrating Tablets, the generic equivalent of ADZENYS XR-ODT®, in multiple strengths. That product currently has one approved generic and one authorised generic, with an addressable market size of approximately USD 172 million.
The latest approval marks the second consecutive FDA tentative approval for Granules Pharmaceuticals, Inc. within a few weeks, strengthening its position in the central nervous system (CNS) therapeutic segment.
Commenting on the development, Dr. Krishna Prasad Chigurupati, Chairman and Managing Director, Granules India Limited, said, “Eligibility for 180-day exclusivity strongly validates our long-term strategy of building a differentiated portfolio of complex generics. It reinforces our commitment to expanding our presence in the CNS therapeutic space while enhancing value creation in the U.S. generics market.”
The development highlights Granules’ growing strengths in complex formulation development and regulatory execution, reinforcing its ability to identify and advance technically challenging products with meaningful differentiation.
