Cadila Healthcare settles patent litigation with Warner Chilcott

12 Dec 2013 Evaluate

Cadila Healthcare and Zydus Pharmaceuticals (USA) Inc. have entered into an agreement in principle with Warner Chilcott Company LLC to settle all outstanding patent litigation related to Asacol HD (mesalamine) delayed-release tablets. The agreement remains subject to preparation and execution of definitive documentation.

Under the terms of the agreement in principle, Warner Chilcott Company will grant Cadila and Zydus a royalty-bearing license to market a generic version of its patented drug Asacol HD beginning on November 15, 2015 or earlier under certain circumstances, following receipt by Zydus of final approval from the US Food and Drug Administration (USFDA) of its Abbreviated New Drug Application (ANDA) for generic version of Asacol HD.

Alternatively, if Zydus does not receive USFDA approval of its generic version of Asacol HD by July 1, 2016, Zydus will be permitted to launch an authorized generic version of Asacol HD beginning on July 1, 2016.

Zydus Lifesciences Share Price

931.45 -3.75 (-0.40%)
05-Dec-2025 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1804.95
Dr. Reddys Lab 1275.05
Cipla 1520.55
Zydus Lifesciences 931.45
Lupin 2097.65
View more..
Register Now to get our Free Newsletter & much more!

© 2025 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.

×