Global pharmaceutical leader Lupin Limited (Lupin) has announced the approval of its Abbreviated New Drug Application by the United States Food and Drug Administration (U.S. FDA) for Topiramate Extended-Release Capsules. This approval covers dosages of 25 mg, 50 mg, 100 mg, and 200 mg, allowing Lupin to market a generic equivalent of Trokendi® XR Extended-Release Capsules, produced by Supernus Pharmaceuticals, Inc. The product will be manufactured at Lupin’s Pithampur facility in India.
Topiramate Extended-Release Capsules are prescribed as initial monotherapy for treating partial-onset or primary generalized tonic-clonic seizures in patients aged six and older.
The reference drug, Trokendi® XR, had an estimated annual sale of USD 253 million in the U.S. as of May 2024, according to IQVIA MAT data.
Lupin is a pioneering transnational pharmaceutical company headquartered in Mumbai, India. The company develops and commercializes a broad range of branded and generic formulations, biotechnology products, and APIs across more than 100 markets, including the U.S., India, South Africa, the Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East.
Lupin holds leadership positions in the cardiovascular, anti-diabetic, and respiratory segments and maintains a significant presence in the anti-infective, gastrointestinal (GI), central nervous system (CNS), and women’s health areas. It ranks as the third-largest pharmaceutical company in the U.S. by prescriptions. In FY24, Lupin invested 7.8% of its revenue in research and development.
The company operates 15 manufacturing sites, 7 research centers, and employs more than 20,000 professionals globally. Lupin has consistently been recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.
