Zydus receives final approval from USFDA and 180 days shared exclusivity for Brivaracetam Tablets

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

Zydus Lifesciences Limited’s (formerly known as Cadila Healthcare Limited) U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has 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 USP 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg. It is therefore eligible for 180 days of shared generic drug exclusivity for Brivaracetam Tablets USP 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg.

Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. 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 USD 412 mn 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.