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 generic and one authorized generic, with an addressable market of about $172 million.
The company said the tentative approval for generic DYANAVEL XR tablets marks the second consecutive approval for Granules Pharmaceuticals within a few weeks, highlighting its growing capabilities in complex formulation development and regulatory execution.
Dr. Krishna Prasad Chigurupati, chairman & managing director, Granules India, said, “Having a product that is eligible for 180-day exclusivity, Granules 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 India is primarily involved in the manufacturing and sale of active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs).
The company’s consolidated net profit declined 16.3% to Rs 112.64 crore, while net sales increased 3.4% to Rs 1,208.79 crore in Q2 FY26 compared with Q2 FY25.