Lupin announced FDA approval for its Abbreviated New Drug Application (ANDA) for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules on November 19, 2024. This approval allows Lupin to market a generic version of Adderall XR, a medication used in the treatment of attention deficit hyperactivity disorder (ADHD). The approval spans dosage strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg.
Manufacturing and Market Opportunity
The generic drug will be manufactured at Lupin’s Somerset facility in the United States. Adderall XR, marketed by Takeda Pharmaceuticals U.S.A., Inc., had estimated annual sales of USD 865 million in the United States, according to IQVIA MAT September 2024 data, highlighting the potential market for Lupin's generic alternative.
Indication and Patient Population
The extended-release capsules are indicated for the treatment of ADHD in adult and pediatric patients aged six years and older. This provides a therapeutic option for a wide range of patients affected by ADHD.
