In a significant boost to its U.S. generics portfolio, global pharmaceutical company Lupin has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Oxcarbazepine Extended-Release (ER) Tablets. The approval covers 150 mg, 300 mg, and 600 mg dosage strengths.
These tablets are the generic equivalent of Oxtellar XR ER Tablets, originally developed by Supernus Pharmaceuticals, Inc., and are used in the treatment of partial-onset seizures in patients aged six years and above.
Lupin plans to manufacture the approved product at its advanced formulation facility located in Nagpur, India.
As per IQVIA MAT data for April 2025, the U.S. market for Oxcarbazepine ER Tablets (Oxtellar XR) is valued at approximately USD 206 million annually, highlighting the substantial revenue potential this approval unlocks for Lupin in the neurology segment.
The tentative approval indicates that Lupin’s product has met all required safety and efficacy standards but cannot be marketed until certain patent or exclusivity issues are resolved.
This development marks another strategic step in Lupin’s efforts to expand its footprint in the U.S. generics market, particularly in complex therapies such as central nervous system disorders.