Lupin Limited has announced the launch of Topiramate Extended-Release Capsules in the United States, marking another key addition to its US generics portfolio. The launch follows approval of the company’s Abbreviated New Drug Application (ANDA) by the U.S. Food and Drug Administration.
The newly launched product is available in strengths of 25 mg, 50 mg, 100 mg, and 200 mg. Lupin stated that its Topiramate Extended-Release Capsules are bioequivalent to the reference listed drug Trokendi XR®, which is marketed by Supernus Pharmaceuticals, Inc..
Topiramate Extended-Release Capsules are indicated for a wide range of neurological conditions. These include use as initial monotherapy for the treatment of partial-onset seizures or primary generalized tonic-clonic seizures in patients aged 6 years and above. The drug is also approved as adjunctive therapy for partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in the same age group. In addition, the medication is indicated for the preventive treatment of migraine in patients aged 12 years and older.
According to market data from IQVIA, Topiramate Extended-Release Capsules have an estimated annual sales potential of USD 164 million in the US, based on MAT December 2025 figures. This highlights the commercial significance of the launch and underlines the opportunity for Lupin to strengthen its presence in the US central nervous system (CNS) therapy segment.
