Lupin Limited announced the launch of Topiramate Extended-Release Capsules in the United States after receiving approval for its Abbreviated New Drug Application from the U.S. Food and Drug Administration. The product is available in strengths of 25 mg, 50 mg, 100 mg and 200 mg and is bioequivalent to Trokendi XR® Extended-Release Capsules, the reference listed drug from Supernus Pharmaceuticals, Inc.
The medication is indicated for the treatment of partial-onset and primary generalized tonic-clonic seizures in patients aged six years and above, as well as for the preventive treatment of migraine in patients aged 12 years and older. According to IQVIA MAT data for December 2025, the product has estimated annual sales of approximately USD 164 million in the U.S. market.
Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with a strong presence across developed and emerging markets. Founded in 1968, the company has built a diversified portfolio spanning branded and generic formulations, complex generics, biotechnology products and active pharmaceutical ingredients. Lupin is widely recognised for its depth in research-driven manufacturing and its ability to scale high-quality, affordable medicines across geographies.
The company has a significant footprint in key markets including India, the United States, Europe, Japan, Latin America, Africa and the Asia-Pacific region, with products marketed in over 100 countries. In India and the U.S., Lupin holds leadership positions across multiple therapy areas such as respiratory, cardiovascular, anti-diabetic, central nervous system, gastrointestinal, anti-infective and women’s health.
Lupin operates 15 state-of-the-art manufacturing facilities and seven research and development centres globally, supporting innovation in complex generics, inhalation products and specialty formulations. Its integrated capabilities allow for end-to-end control across development, manufacturing and commercialisation.
Beyond pharmaceuticals, Lupin continues to expand its healthcare ecosystem through subsidiaries such as Lupin Diagnostics, Lupin Digital Health and Lupin Manufacturing Solutions. With a workforce of more than 24,000 professionals worldwide, the company remains focused on improving patient outcomes through science-led innovation, operational excellence and responsible growth.
