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Lupin Gains USFDA Approval for Generic Adderall XR for ADHD Treatment

• Lupin has received USFDA approval for its generic version of Adderall XR extended-release capsules, a mixed salts amphetamine product. • The approved drug, Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules, treats ADHD in adults and children. • This generic equivalent aims to provide a more accessible treatment option for patients with attention deficit hyperactivity disorder. • The annual sales for Adderall XR reached approximately $865 million in the U.S. as of September 2024, per IQVIA data.

Global pharmaceutical company Lupin Limited has secured approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) concerning Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules. This medication is a generic equivalent to Takeda Pharmaceuticals USA's Adderall XR Extended-Release Capsules and will be manufactured at Lupin’s Somerset facility in the US.
The approval marks a significant step in providing a more accessible treatment option for attention deficit hyperactivity disorder (ADHD) patients. The drug is indicated for both adult and pediatric patients, specifically those 6 years and older, who have been diagnosed with ADHD.

Clinical Application and Market Impact

The approved medication contains mixed salts of a single-entity amphetamine product, designed to address the symptoms of ADHD through a controlled-release mechanism. This allows for a once-daily dosage, providing extended symptom control throughout the day.
According to IQVIA data from September 2024, the annual sales for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules (RLD Adderall XR) reached approximately $865 million in the U.S. This indicates a substantial market demand for ADHD medications, which Lupin's generic version is now positioned to address.
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Reference News

[1]
Lupin receives USFDA approval for mixed salts of a single-entity amphetamine ER capsules
indianpharmapost.com · Nov 20, 2024

Lupin receives USFDA approval for mixed salts of a single-entity amphetamine ER capsules, to be manufactured at its Some...

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