Lupin announced the launch of Topiramate Extended-Release Capsules (25 mg, 50 mg, 100 mg, and 200 mg) in the United States, following FDA approval. These capsules, bioequivalent to Trokendi XR®, are indicated for treating partial-onset or primary generalized tonic-clonic seizures, and preventing migraine. The US market for these capsules has an estimated annual sale of $164 million.
Topiramate Capsules Launched
Global pharmaceutical major Lupin Limited (Lupin) has launched Topiramate Extended-Release Capsules in the United States. The capsules are available in strengths of 25 mg, 50 mg, 100 mg, and 200 mg. This launch follows the approval of Lupin’s Abbreviated New Drug Application (ANDA) by the U.S. FDA.
Therapeutic Use
Topiramate Extended-Release Capsules are bioequivalent to Trokendi XR® Extended-Release Capsules. The capsules are indicated as initial monotherapy for treating partial-onset or primary generalized tonic-clonic seizures in patients 6 years and older. They are also used as adjunctive therapy for similar seizure types and seizures associated with Lennox-Gastaut syndrome in the same age group. Additionally, they serve for preventive treatment of migraine in patients 12 years of age and older.
Market Overview
The estimated annual sale for Topiramate Extended-Release Capsules in the U.S. is USD 164 million (IQVIA MAT Dec 2025). This launch will allow Lupin to expand its portfolio in the US market.
Company Commitment
Lupin remains committed to improving patient health outcomes through its subsidiaries, including Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions. The company distributes products in over 100 markets and has a strong position in India and the U.S. across various therapy areas.
Source: BSE
