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Lupin gets US FDA nod for Brivaracetam oral solution, launches in US marketShares of Lupin Ltd ended at ₹2,248.90, up by ₹3.80, or 0.17%, on the BSE.By Jomy Jos Pullokaran  February 24, 2026, 7:37:15 PM IST (Published)2 Min ReadDrug firm Lupin Ltd on Tuesday (February 24) announced that it has received approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Brivaracetam Oral Solution 10 mg/mL.

Brivaracetam is bioequivalent to Briviact Oral Solution 10 mg/mL of UCB, Inc. and is indicated for the treatment of partial-onset seizures in patients aged 1 month and older. Following the approval, Lupin has initiated the launch of Brivaracetam Oral Solution in the United States.

The reference drug, Brivaracetam Oral Solution (RLD Briviact), had estimated annual sales of $135 million in the US, according to IQVIA MAT December 2025 data.

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Third Quarter Results

Lupin Ltd reported a consolidated net profit after tax of ₹1,175.6 crore in Q3 FY26, down sequentially from Q2 FY26 but up 37.5% compared to Q3 FY25. Consolidated revenue from operations stood at ₹7,167.5 crore, up 1.7% quarter-on-quarter and 24.3% year-on-year.

On a standalone basis, net profit after tax was ₹717.5 crore in Q3 FY26, down from ₹1,357.4 crore in Q2 FY26 and ₹1,114.7 crore in Q3 FY25. Standalone revenue from operations was ₹4,601.1 crore, up 12.5% sequentially and 9.3% year-on-year.

Exceptional items during the quarter included a provision of ₹449.4 crore for antitrust litigations and ₹134.8 crore toward a settlement with Astellas. The implementation of the New Labour Codes resulted in an incremental cost of ₹49.6 crore at the standalone level and ₹51.2 crore on a consolidated basis.

Also Read: Lupin shares may see up to 16% upside post Q3, analysts say — should you buy?

The company also recorded gains from the divestment of its OTC and API R&D businesses, amounting to ₹658.9 crore and ₹3.7 crore, respectively. Additionally, a provision of ₹70 crore was made toward the diminution in the value of investment in a subsidiary.

The company reported a gross profit of ₹5,222.4 crore in Q3 FY2026 compared to ₹3,897 crore in Q3 FY2025, with a gross margin of 73.5%. Personnel cost stood at ₹1,143.3 crore, accounting for 16.1% of sales, compared to ₹984.4 crore in the year-ago quarter.

Shares of Lupin Ltd ended at ₹2,248.90, up by ₹3.80, or 0.17%, on the BSE.Continue Reading(Edited by : Jomy Jos Pullokaran)TagsLupinshare market todayUS FDA