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Lupin (LUPIN) announced U.S. launch of Topiramate Extended-Release Capsules in 25 mg, 50 mg, 100 mg and 200 mg strengths following U.S. FDA approval of its ANDA. The product is bioequivalent to the reference listed drug Trokendi XR and carries an estimated U.S. annual market of USD 164 million (IQVIA MAT Dec 2025).
The approval covers indications for seizure treatment in patients aged 6 years and older and migraine prevention in patients 12 years and older.