Global pharmaceutical powerhouse Lupin Limited announced a significant expansion of its United States portfolio today with the official launch of Topiramate Extended-Release Capsules.
The move follows the receipt of approval for its Abbreviated New Drug Application (ANDA) from the U.S. FDA.
The newly launched product is available in strengths of 25 mg, 50 mg, 100 mg, and 200 mg. As a bioequivalent to Supernus Pharmaceuticals’ Trokendi XR®, Lupin’s offering enters a high-value therapeutic segment.
According to IQVIA MAT December 2025 data, Topiramate Extended-Release Capsules command an estimated annual sale of USD 164 million in the U.S. market.
This launch strengthens Lupin’s position in the Central Nervous System (CNS) therapy area. The medication is indicated for:
- Initial monotherapy or adjunctive therapy for partial-onset or primary generalized tonic-clonic seizures in patients aged 6 and older.
- Treatment of seizures associated with Lennox-Gastaut syndrome.
- Preventive treatment of migraine in patients 12 years of age and older.
Headquartered in Mumbai, Lupin continues to leverage its extensive R&D and manufacturing capabilities—comprising 15 global sites and 7 research centers—to maintain its “strong position” in the U.S. and India.
This latest launch aligns with the company’s commitment to delivering complex generics and improving patient health outcomes across its 100+ distribution markets.
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