Zydus Lifesciences’ arm gets USFDA’s final approval to market Brexpiprazole Tablets

12 Jan 2023 Evaluate

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.

Zydus Lifesciences Share Price

890.60 14.25 (1.63%)
20-Mar-2026 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1777.45
Dr. Reddys Lab 1298.95
Cipla 1255.85
Zydus Lifesciences 890.60
Lupin 2322.45
View more..
Register Now to get our Free Newsletter & much more!

© 2026 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.

×