Zydus gets USFDA nod, 180 days shared exclusivity for Brivaracetam

Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.

Zydus Lifesciences said that its US subsidiary Zydus Pharmaceuticals (USA) Inc. received final approval from the United States Food and Drug Administration (USFDA) to market Brivaracetam tablets USP 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg. (USRLD: Briviact).

Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Brivaracetam tablets. It is therefore eligible for 180 days of shared generic drug exclusivity for Brivaracetam tablets.

The drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India.

Brivaracetam tablets USP 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg had annual sales of $412 million in the United States according to IQVIA data (IQVIA MAT August 2022).

The group now has 326 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The company's consolidated net profit fell 11.7% to Rs 518.3 crore on a 1.8% increase in total income from operations to Rs 4,072.7 crore in Q1 FY23 over Q1 FY22.

Shares of Zydus Life rose 2.61% to Rs 420 on Tuesday, 4 October 2022.

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