Lupin gets US FDA tentative nod for oxcarbazepine ER tablets

Drug maker, Lupin Ltd, on Saturday (June 7) said it has received tentative approval from the U.S. 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.

The drug is the generic equivalent of Supernus Pharmaceuticals’ Oxtellar XR and is used to treat partial-onset seizures in patients aged six and above. The product will be manufactured at Lupin’s Nagpur facility in India. According to IQVIA MAT data from April 2025, Oxcarbazepine ER Tablets (RLD Oxtellar XR®) recorded annual US sales of approximately $206 million.

Fourth Quarter

Revenue for the quarter increased by 12.2% from the same quarter last year to ₹5,567.1 crore. However, when compared to the December quarter, the topline was lower by 3.5%. A CNBC-TV18 poll had pegged the revenue to be at ₹5,537.7 crore.

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Lupin's Earnings Before Interest, Tax, Depreciation and Amortisation (EBITDA) increased by 22.5% from last year to ₹996.85 crore. The EBITDA figure was lower than the CNBC-TV18 estimate of ₹1,209.16 crore. The company's margin expanded to 21.9% in the fourth quarter from 20.1% in the previous year. However, it contracted from the previous quarter's 23.5%.

Lupin's profit of ₹794.86 crore was higher than expectations of ₹717.3 crore. It was up 121.1% from ₹359.43 crore in the previous year. It was also 7.9% higher than the previous quarter's ₹736.59 crore. Lupin's growth was led by the North American market, where sales stood at ₹2,261.8 crore from ₹1,900.6 crore in the previous year. It was up 6.6% sequentially from ₹2,121.3 crore.

US sales for the fourth quarter were at $245 million compared to $209 million in the previous year and $235 million in the previous quarter. Sales in the growth market increased by 30% from the same quarter last year to ₹691.5 crore, while Indian markets grew by 7% from the previous year to ₹1,711.3 crore.

Also Read: Lupin sees US revenue stabilising at $250 million per quarter

On Friday (June 6), shares of Lupin Ltd ended at ₹1,994.00, down by ₹1.30, or 0.065%, on the BSE.