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Lupin Launches Topiramate Extended-Release Capsules in the United States

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MUMBAI, India & NAPLES, Fla., Feb. 4, 2026 /PRNewswire/ -- Global pharma major Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced the launch of Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg, and 200 mg, in the United States, following the approval for its Abbreviated New Drug Application (ANDA) from the U.S. FDA. 

 

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Topiramate Extended-Release Capsules are bioequivalent to the reference listed drug (RLD), Trokendi XR® Extended-Release Capsules of Supernus Pharmaceuticals, Inc. (Supernus). It is indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older, as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older, and for the preventive treatment of migraine in patients 12 years of age and older.

Topiramate Extended-Release Capsules has an estimated annual sale of USD 164 million in the U.S. (IQVIA MAT Dec 2025).

About Lupin 
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position 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 has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 24,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries - Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions. 

To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin

*Safe Harbor Statement 

Trokendi XR® is a registered trademark of Supernus Pharmaceuticals, Inc.

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SOURCE Lupin Inc.


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