Granules Pharmaceuticals, Inc., the wholly owned US subsidiary of Granules India Limited, has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for generic Amphetamine Extended-Release Tablets. The approval covers strengths of 5 mg, 10 mg, 15 mg, and 20 mg and represents the generic version of DYANAVEL XR.
According to the company, the ANDA has been determined by the FDA to be eligible for 180-day exclusivity. This is a key milestone, as exclusivity allows the first approved generic manufacturer to enjoy a limited competition window in the US market. The development further strengthens Granules’ position in complex and differentiated generic formulations aimed at regulated markets such as the United States.
The generic Amphetamine Extended-Release Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The product has an estimated market size of around USD 41 million, offering Granules a meaningful commercial opportunity once final approval and launch timelines are achieved.
This tentative approval follows another recent regulatory success for the company. On December 22, 2025, Granules Pharmaceuticals, Inc. received tentative approval for Amphetamine Extended-Release Orally Disintegrating Tablets, the generic equivalent of ADZENYS XR-ODT. That product is available in multiple strengths ranging from 3.1 mg to 18.8 mg and is also used for the treatment of ADHD.
The ADZENYS XR-ODT generic market currently has only one approved generic and one authorised generic, with an addressable market size of approximately USD 172 million. This limited competition positions Granules favourably to expand access to the therapy and capture market share upon launch.
