Lupin Limited has announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Oxcarbazepine Extended-Release (ER) Tablets in 150 mg, 300 mg, and 600 mg strengths.
These tablets are the generic equivalent of Oxtellar XR® ER Tablets by Supernus Pharmaceuticals and are indicated for the treatment of partial-onset seizures in patients aged 6 years and above. Lupin’s version of the drug will be manufactured at its Nagpur facility in India.
According to IQVIA MAT April 2025 data, Oxcarbazepine ER Tablets (RLD Oxtellar XR®) recorded estimated annual sales of USD 206 million in the United States, underscoring the potential market opportunity for Lupin.
Headquartered in Mumbai, Lupin is a leading global pharmaceutical company with a strong footprint in the U.S. and India. The company focuses on a broad range of therapy areas including central nervous system disorders, respiratory, cardiovascular, anti-infective, and women’s health. It operates 15 manufacturing sites and 7 research centers globally, supported by over 23,000 employees.
Lupin continues to expand its U.S. portfolio of complex generics and remains committed to delivering high-quality, affordable medicines that improve health outcomes for patients around the world.
