Zydus Lifesciences’ subsidiary -- Zydus Worldwide DMCC (Zydus) has received final approval from the United States Food and Drug Administration (USFDA) to market Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg (USRLD: REXULTI tablets).
Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg and therefore is eligible for 180 days of shared generic drug exclusivity for Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg.
Brexpiprazole tablets had annual sales of $1,548 million in the United States according to IQVIA data (IQVIA MAT Sept. 2022). The group now has 340 approvals and has so far filed over 431 ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.
