Zydus Lifesciences gets FDA final approval for Brivaracetam generic
Zydus Lifesciences (previously Cadila Healthcare) said that its US subsidiary Zydus Pharmaceuticals (USA) has bagged final approval to market Brivaracetam Tablets USP 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg from the US Food and Drug Administration (FDA).
The product is a generic of Briviact, which has approval for the treatment of partial-onset seizures in patients aged four years of age and older. Zydus Lifesciences was given tentative approval for the seizures drug generic in June 2021.
Zydus Lifesciences said that it was among the first abbreviated new drug application (ANDA) applicants for filing a substantially complete ANDA with a paragraph IV certification for Brivaracetam Tablets USP 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg. As a result, the Indian pharma company has eligibility for 180 days of shared generic drug exclusivity for Brivaracetam Tablets USP 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg.
The seizures drug will be manufactured by Zydus Lifesciences at its formulation manufacturing plant in Ahmedabad SEZ.
As per IQVIA data (IQVIA MAT August 2022), the US annual sales of Brivaracetam Tablets USP 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg were $412 million.