Lupin Receives Tentative Approval from US FDA for Extended-Release Oxcarbazepine Tablets

Lupin Receives Tentative Approval from US FDA for Extended-Release Oxcarbazepine Tablets
On Saturday (June 7), drug manufacturer Lupin Ltd announced that it has secured tentative approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) concerning Oxcarbazepine Extended-Release (ER) Tablets in 150 mg, 300 mg, and 600 mg dosages.

This medication is the generic equivalent of Supernus Pharmaceuticals’ Oxtellar XR and is prescribed for treating partial-onset seizures in patients aged six and older. Production will take place at Lupin’s facility in Nagpur, India. According to IQVIA MAT data from April 2025, Oxcarbazepine ER Tablets (RLD Oxtellar XR®) achieved annual sales of about $206 million in the U.S.

Fourth Quarter
Revenue for the quarter rose by 12.2% compared to the same quarter last year, reaching ₹5,567.1 crore. However, it represented a 3.5% decline from the December quarter. A poll by CNBC-TV18 had estimated revenue at ₹5,537.7 crore.Also Read: US court permits Lupin, Zydus Life to broaden Myrbetriq patent argument scope

Lupin’s Earnings Before Interest, Tax, Depreciation, and Amortisation (EBITDA) increased by 22.5% year-on-year to ₹996.85 crore, although this figure fell short of the CNBC-TV18 estimate of ₹1,209.16 crore. The company’s margin expanded to 21.9% in the fourth quarter, up from 20.1% the previous year, but contracted from 23.5% in the last quarter.

Lupin reported a profit of ₹794.86 crore, exceeding expectations of ₹717.3 crore. This figure marks a 121.1% increase from ₹359.43 crore the year prior and is 7.9% higher than the previous quarter’s ₹736.59 crore. Growth was primarily driven by the North American market, where sales reached ₹2,261.8 crore, up from ₹1,900.6 crore in the last year. This also reflects a sequential increase of 6.6% from ₹2,121.3 crore.

In the fourth quarter, U.S. sales amounted to $245 million, compared to $209 million in the previous year and $235 million in the previous quarter. Sales in the growth market surged by 30% compared to the same quarter last year, standing at ₹691.5 crore, while Indian markets saw a 7% increase to ₹1,711.3 crore.

Also Read: Lupin anticipates U.S. revenue stabilizing at $250 million quarterly

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

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