Lupin receives approval from U.S. FDA for Topiramate Extended-Release Capsules

Lupin recently announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg, and 200 mg, to market a generic equivalent of Trokendi XR Extended-Release Capsules, 25 mg, 50 mg, 100 mg, and 200 mg, of Supernus Pharmaceuticals. This product will be manufactured at Lupin’s Pithampur facility in India.

Topiramate Extended-Release Capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalised tonic-clonic seizures in patients six years of age and older.

Topiramate Extended-Release Capsules (RLD Trokendi XR) had an estimated annual sale of USD 253 million in the U.S. (IQVIA MAT May 2024).