Lupin gains on USFDA nod for Brivaracetam tablets

Lupin rallied 3.50% to Rs 750.55 after the drug maker said that it has received an approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Brivaracetam tablets.

The approved ANDA is a generic equivalent of Briviact tablets of UCB Inc. Brivaracetam is used alone and in combination with other medications to control partial onset seizures (seizures that involve only one part of the brain) in adults, children, and infants 1 month of age and older. Brivaracetam is in a class of medications called anticonvulsants.

The pharmaceutical company said that the product will be manufactured at its facility in Nagpur, India.

According to IQVIA MAT September 2022 data, Brivaracetam tablets (RLD Briviact) had estimated annual sales of $420 million in the US.

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

On consolidated basis the company reported net profit of Rs 129.73 crore in Q2 FY23 as against net loss of Rs 2,098.04 crore in Q2 FY22. Revenue from operations rose 2.2% to Rs 4,091.16 crore in Q2 FY23 as compared to Rs 4,003.42 crore in Q2 FY22.

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