Lupin Launches Topiramate Capsules in U.S. Market
Filing Summary
Lupin Limited has launched Topiramate Extended-Release Capsules in the United States. The product is available in 25 mg, 50 mg, 100 mg, and 200 mg dosages. This follows the approval of its Abbreviated New Drug Application by the U.S. FDA. The capsules are bioequivalent to Trokendi XR® by Supernus Pharmaceuticals. The product is indicated for various seizure treatments and migraine prevention. The estimated annual sales for this product in the U.S. are USD 164 million, according to IQVIA MAT Dec 2025 data.
Lupin Limited has announced the launch of Topiramate Extended-Release Capsules in the United States. The product is available in 25 mg, 50 mg, 100 mg, and 200 mg dosages. This launch follows the approval of its Abbreviated New Drug Application (ANDA) by the U.S. FDA.
The capsules are bioequivalent to the reference listed drug, Trokendi XR® Extended-Release Capsules, developed by Supernus Pharmaceuticals, Inc. The product is indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients aged six years and older. It is also indicated as adjunctive therapy for partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients six years and older. Additionally, it is used for the preventive treatment of migraine in patients aged 12 years and older.
The estimated annual sales for Topiramate Extended-Release Capsules in the U.S. market are USD 164 million, based on IQVIA MAT data from December 2025.
Lupin Limited is a global pharmaceutical leader specializing in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company operates in over 100 markets and maintains a strong presence in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin is committed to improving patient health outcomes through its subsidiaries, including Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.