Granules Pharmaceuticals Inc., a wholly owned subsidiary of Granules India Limited, has received Tentative Approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Amphetamine Extended-Release Orally Disintegrating Tablets. The approval covers strengths of 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg, which are the generic equivalents of ADZENYS XR-ODT®.
The product will be manufactured at Granules’ US-based facility in Chantilly, Virginia. It is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), a condition that requires long-term, patient-friendly treatment options, particularly in pediatric and adolescent populations.
According to IQVIA (IMS Health), the reference product has an estimated market size of approximately USD 172 million in the United States. At present, the market has only one approved generic and one authorised generic, which places Granules in a favourable position once final approval is granted and the product is launched.
The Tentative Approval indicates that Granules’ ANDA has met all regulatory requirements except for any remaining patent or exclusivity considerations. Upon resolution of these factors, the company would be eligible for final approval and commercialisation in the US market.