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

Zydus Lifesciences Limited's (formerly known as Cadila Healthcare Limited) 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 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.

Shares of Cadila Healthcare Limited was last trading in BSE at Rs. 452.15 as compared to the previous close of Rs. 457.55. The total number of shares traded during the day was 104854 in over 4094 trades.

The stock hit an intraday high of Rs. 458.40 and intraday low of 447.40. The net turnover during the day was Rs. 47439540.00.

(*as of 30th September 2022)

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 ZydusWorldwideDMCC USFDA FinalApproval BrexpiprazoleTablets