Granules India gets USFDA tentative nod for generic ADHD tablets

Granules India Ltd on Thursday said its US subsidiary, Granules Pharmaceuticals, Inc, has received tentative approval from the US Food and Drug Administration for its generic amphetamine extended-release tablets indicated for the treatment of attention deficit hyperactivity disorder (ADHD), with eligibility for 180-day exclusivity.

The tentative approval is for the abbreviated new drug application (ANDA) for amphetamine extended-release tablets in strengths of 5 mg, 10 mg, 15 mg and 20 mg, the company said in a regulatory filing.

These tablets are the generic equivalent of DYANAVEL XR, it added.

“The Granules ANDA has been determined to be eligible for 180-day exclusivity by the FDA, reinforcing its growing capabilities in developing and commercialising complex and differentiated generic products for the US market,” the company said.

The product is indicated for the treatment of ADHD and has an estimated market size of $41 million, it added.

Commenting on the development, Krishna Prasad Chigurupati, Chairman and Managing Director of 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 US generics market.”

Granules India said it had earlier received tentative approval on December 22, 2025, for amphetamine extended-release orally disintegrating tablets in strengths of 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg and 18.8 mg, which are also used for the treatment of ADHD.