Zydus Life arm gets USFDA final approval to market Brexpiprazole in US

Zydus Worldwide DMCC , subsidiary of Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to market Brexpiprazole tablets and 180 days shared exclusivity for Brexpiprazole Tablets.

Zydus was one of the first abbreviated new drug applications (ANDA) applicants to submit a substantially complete ANDA with a paragraph IV certification for Brexpiprazole tablets and therefore it is eligible for 180 days of shared generic drug exclusivity for 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.

Brexpiprazole tablet is a reference listed drug of Rexulti tablets.

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

According to IQVIA MAT September 2022, Brexpiprazole tablets had annual sales of $1,548 million in the United States.

As of 30 September 2022, the group has 340 approvals and has so far filed over 431 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 slumped 82.6% to Rs 522.50 crore despite of a 10% increase in total revenue from operations to Rs 4,134.7 crore in Q2 FY23 over Q2 FY22.

Shares of Zydus Lifesciences were up 0.24% to Rs 452.95 on the BSE.

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