#United States #Naples #Lupin Limited #Topiramate #Trokendi XR

Lupin Launches Topiramate Extended-Release Capsules in the United States

On February 4, 2026, Lupin Limited, a prominent global pharmaceutical company based in Mumbai, India, announced the introduction of Topiramate Extended-Release Capsules in the U.S. market. Available in dosages of 25 mg, 50 mg, 100 mg, and 200 mg, these capsules received approval from the U.S. FDA after the company submitted a successful Abbreviated New Drug Application (ANDA).

Topiramate Extended-Release Capsules are bioequivalent to Trokendi XR®, a product from Supernus Pharmaceuticals, meaning they deliver comparable therapeutic effects and safety profiles. This medication is primarily utilized as an initial treatment for patients aged 6 and older who experience partial-onset or primary generalized tonic-clonic seizures. Additionally, it serves as an adjunct therapy for these types of seizures in the same age group, as well as those associated with Lennox-Gastaut syndrome. Furthermore, Topiramate is also indicated for the preventive treatment of migraines in adolescents aged 12 and older.

The annual sales for Topiramate in the U.S. are estimated to be around USD 164 million, showcasing significant market potential for this well-established therapeutic option.

About Lupin Limited

Lupin Limited has a strong global presence, with operations spanning over 100 markets and specializing in various pharmaceutical products. Their offerings include both branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company is recognized for its commitment to improving health outcomes across a range of therapy areas, including respiratory health, cardiovascular care, anti-diabetic treatments, and women's health. Lupin operates 15 state-of-the-art manufacturing facilities along with seven dedicated research centers worldwide, supported by a workforce of over 24,000 professionals.

As a trusted name in healthcare, Lupin not only develops pharmaceutical products but also invests in subsidiaries focused on diagnostics, digital health, and manufacturing solutions. With a goal of enhancing patient health outcomes, Lupin continues to innovate and expand its range of therapeutic solutions.

For more information about its products and initiatives, visit Lupin's official website or follow them on LinkedIn. The launch of Topiramate Extended-Release Capsules marks an important step in Lupin's mission to provide comprehensive treatment options for patients with epilepsy and migraine disorders.