Granules Pharmaceuticals, Inc., a wholly owned subsidiary of Granules India Limited, has received Tentative Approval (TA) from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Amphetamine Extended-Release Tablets. As per the press release, the approval covers strengths of 5 mg, 10 mg, 15 mg, and 20 mg, the generic equivalent of DYANAVEL XR®.
Eligibility for 180-Day Exclusivity Strengthens Market Position
Importantly, the FDA has determined that the Granules ANDA is eligible for 180-day exclusivity. As a result, this milestone underscores the company’s growing 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 addresses an estimated market opportunity of approximately USD 41 million.
Recent Momentum in ADHD Portfolio Expansion
Earlier, on December 22, 2025, Granules received tentative approval for Amphetamine Extended-Release Orally Disintegrating Tablets in strengths ranging from 3.1 mg to 18.8 mg. This product is the generic equivalent of ADZENYS XR-ODT® and is also indicated for ADHD. Currently, the market includes only one approved generic and one authorised generic, with an addressable market size of USD 172 million. Consequently, this positions Granules favourably to expand patient access to this critical therapy upon launch.
Second Consecutive FDA Tentative Approval in Weeks
Notably, the tentative approval for generic gDYANAVEL XR tablets marks the second consecutive approval for Granules Pharmaceuticals, Inc. within a span of just a few weeks, reflecting strong execution across development and regulatory pathways.
Leadership Perspective on Strategic Impact
Commenting on the development, Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India Limited, said that securing a product eligible for 180-day exclusivity strongly validates Granules’ long-term strategy of building a differentiated portfolio of complex generics. He further emphasised that the achievement reinforces the company’s commitment to strengthening its presence in the central nervous system (CNS) therapeutic space while enhancing value creation in the U.S. generics market.
Demonstrating Strength in Complex Formulation and Regulatory Execution
Overall, this achievement highlights Granules’ expanding capabilities in complex formulation development and regulatory execution. Moreover, it reinforces the company’s ability to identify, develop, and advance technically challenging products that deliver meaningful differentiation and long-term value.