Lupin Receives FDA Approval for Generic Adderall XR Capsules

Key Insights

• Lupin has secured FDA approval for its generic version of Adderall XR extended-release capsules, addressing attention deficit hyperactivity disorder (ADHD).
• The approved ANDA covers multiple dosages (5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg) of the mixed salts amphetamine product.
• This generic equivalent aims to compete in a market with estimated annual sales of $865 million in the U.S.

Lupin Limited has 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, a generic equivalent of Takeda Pharmaceuticals USA, Inc.’s Adderall XR. The approval spans dosages of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg.

The approved capsules are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in both adult and pediatric patients aged six years and older. ADHD is a neurodevelopmental disorder affecting millions, characterized by inattention, hyperactivity, and impulsivity.

Market and Manufacturing

The market for dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules (RLD Adderall XR) had estimated annual sales of USD 865 million in the US, according to IQVIA MAT September 2024 data. Lupin plans to manufacture the product at its Somerset facility in the US.

Lupin Limited, headquartered in Mumbai, India, distributes its pharmaceutical products across over 100 markets globally. The company specializes in a range of pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.