Granules Secures FDA Nod for Generic Amphetamine With 180-Day Exclusivity

Granules Pharmaceuticals Inc., based in Chantilly, Virginia and wholly owned by Granules India Ltd, announced a significant milestone with the U.S. Food and Drug Administration granting tentative approval for its Abbreviated New Drug Application (ANDA) for Amphetamine Extended-Release Orally Disintegrating Tablets. This product is the generic equivalent of ADZENYS XR-ODT®, used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The approval covers multiple dosage strengths ranging from 3.1 mg to 18.8 mg. Importantly, Granules has secured 180-day exclusivity, a competitive advantage that allows the company to be the sole generic supplier for six months once final approval is granted.

Key Highlights

• FDA tentative approval for generic Amphetamine ER ODT tablets.
• Dosage strengths: 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg.
• Product to be manufactured at Granules’ U.S. facility in Chantilly, Virginia.
• Indicated for ADHD treatment, targeting a USD 172 million market (IQVIA data).
• 180-day exclusivity provides strong first-mover advantage in the U.S. market.

This development underscores Granules’ growing presence in the U.S. generics market and highlights its strategic focus on complex formulations with exclusivity benefits.

Sources: Granules India Press Release, Business Upturn, Indian Pharma Post