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Shares of Lupin surged on Wednesday after the company's Abbreviated New Drug Application (ANDA) of Brivaracetam Tablets got an approval from the United States Food and Drug Administration (USFDA).

The regulator has approved Lupin’s ANDA for Brivaracetam Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, the company said in a press release.

The Brivaracetam Tablets is a generic equivalent of UCB’s Briviact Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg. Lupin’s product will be manufactured at the company’s facility in Nagpur, Maharashtra.

As per IQVIA MAT data for September 2022, the Brivaracetam Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg garnered an estimated annual sales of $420 million in the US.

Earlier this month, Lupin launched an authorised generic version of PENNSAID (Diclofenac Sodium Topical Solution) 2 percent w/w of Horizon Pharma Therapeutics in the United States, used for the treatment of inflammatory diseases like gout and osteoarthritis to relieve pain in the knee and other joints.

Further, Lupin announced the launch of Rufinamide Tablets USP, 200 mg and 400 mg in the US for marketing a generic equivalent of the Banzel Tablets, 200 mg, and 400 mg, used in the treatment of seizures associated with Lennox-Gastaut Syndrome.

Shares of Lupin are currently trading 3.5 percent higher at Rs 751.60.