USFDA Grants Tentative Approval, 180-Day Exclusivity to Granules' Generic Amphetamine XR
Hyderabad: Granules Pharmaceuticals, Inc., a wholly owned subsidiary of Granules India Limited, has received tentative approval (TA) from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for generic Amphetamine Extended-Release Tablets, the company said in a regulatory filing on Thursday.
The approval covers tablet strengths of 5 mg, 10 mg, 15 mg, and 20 mg, which are the generic equivalent of DYANAVEL XR®, a medication indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Notably, the ANDA has been deemed eligible for 180-day exclusivity by the US FDA.
According to the company, the product has an estimated market size of approximately USD 41 million in the United States, underscoring its commercial potential once final approval and launch timelines are achieved.
Granules highlighted that this development strengthens its capabilities in developing and commercialising complex and differentiated generic products for the U.S. market. The tentative approval for generic gDYANAVEL XR tablets marks the second consecutive tentative approval received by Granules Pharmaceuticals, Inc. within a span of a few weeks.
Earlier, on December 22, 2025, the company had received tentative approval for Amphetamine Extended-Release Orally Disintegrating Tablets, the generic equivalent of ADZENYS XR-ODT®, in multiple strengths ranging from 3.1 mg to 18.8 mg. That product currently faces limited competition, with only one approved generic and one authorised generic, and carries an addressable market opportunity of around USD 172 million, the company said.
Commenting on the latest development, Dr Krishna Prasad Chigurupati, Chairman and Managing Director, Granules India Limited, said,
“Having a product that is eligible for 180-day exclusivity strongly validates our long-term strategy of building a differentiated portfolio of complex generics. It also reinforces our commitment to strengthening our presence in the central nervous system (CNS) therapeutic space while enhancing value creation in the U.S. generics market.”
Granules said the milestone reflects its expanding capabilities in complex formulation development and regulatory execution, and its ability to identify and advance technically challenging products that offer meaningful differentiation and long-term value.
Granules India Limited is a vertically integrated pharmaceutical company with operations spanning active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), finished dosages, and peptide CDMO services. The company operates 11 manufacturing facilities across India, the United States, and Switzerland, and supplies products to more than 80 countries worldwide.
