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.
