Lupin Gets Approval from USFDA for Oxcarbazepine ER Tablets

• Lupin received USFDA approval for Oxcarbazepine ER tablets (150–600 mg)

• The drug is bioequivalent to Supernus's Oxtellar XR for partial seizures

• Manufacturing will take place at Lupin’s Nagpur facility in India

Lupin Limited has obtained approval from the USFDA for its 150 mg, 300 mg, and 600 mg strength Oxcarbazepine ER tablets. Lupin's ER tablets are substitutable with Supernus Pharmaceutical's Oxtellar XR, which is an RLD, for the treatment of partial-onset seizures in patients six years of age and older.

The product would be produced in Lupin's world-class facility at Nagpur, India. Oxcarbazepine ER tablets (RLD Oxtellar XR) had around US dollars 206 million in yearly U.S. sales, as per IQVIA MAT data as of April 2025, and represent a compelling opportunity in the market for Lupin.

Lupin also congeals itself as one of the world's leading drug companies. Based in Mumbai, India, the firm sells its products in more than 100 countries and operates in a diversified portfolio of branded and generic formulations, complex generics, biotech drugs, and active pharmaceutical ingredients (APIs).

The company reported strong financials recently, with close net profit growing 114.9 percent year on year to Rs. 772.52 crore in Q4 FY25 and net sales up 13.6 percent at Rs. 5,562.20 crore. Depending on investors' confidence, Lupin's stock gained 0.20 percent to close at Rs. 1,999.20 on the BSE.

Also Read: Lupin Licenses Biosimilar Ranibizumab for Latin American Markets

With this recent approval, Lupin is set to create its presence in the central nervous system (CNS) space of the U.S. market and establish itself as a strong player in the high-value generic segment.