Zydus receives USFDA final approval for Brexpiprazole Tablets

Zydus Lifesciences Limited’s (formerly known as Cadila Healthcare Limited) subsidiary, Zydus Worldwide DMCC received final approval from the United States Food and Drug Administration (USFDA) to market Brexpiprazole Tablets, as per an exchange filing by the company.

The company got approval for Brexpiprazole tablets in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg dosages (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 the Brexpiprazole tablets.

Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults.

It is also indicated for the treatment of schizophrenia in adults and pediatric patients ages 13 years and older.

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

Brexpiprazole tablets had annual sales of USD 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.