Lupin receives FDA approval for generic version of Adderall XR

On 19 November 2024, Lupin announced that it had received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules. The approval covers dosage strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg, which are the generic equivalent of Adderall XR Extended-Release Capsules marketed by Takeda Pharmaceuticals U.S.A., Inc.

The product will be manufactured at Lupin’s Somerset facility in the United States. The extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and in paediatric patients aged six years and older.

According to IQVIA MAT September 2024 data, the reference product (Adderall XR) recorded estimated annual sales of USD 865 million in the United States.