Mumbai, Jan. 8 -- The company said the ANDA has been determined by the US Food and Drug Administration (USFDA) to be eligible for 180-day exclusivity. The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and has an estimated market size of around $41 million. The exclusivity status strengthens Granules' position in developing and commercializing complex and differentiated generic products for the US market.

Earlier, on 22 December 2025, Granules Pharmaceuticals received tentative approval for Amphetamine Extended-Release Orally Disintegrating Tablets in multiple strengths, the generic equivalent of ADZENYS XR-ODT, also used for the treatment of ADHD. This product currently has only one approved ge...