The U.S. Court of Appeals for the Federal Circuit has affirmed judgement in favor of Zydus Pharmaceuticals (USA) Inc., holding that its proposed generic version of Lialda does not infringe a U.S. Patent. Zydus is the first pharmaceutical company to file an abbreviated new drug application for a generic version of mesalamine in the U.S.
Zydus Cadila chairman and managing director Pankaj R. Patel said, “We welcome this decision which is a positive step and will help us further our mission of making available high-quality, affordable generic products to our customers and their patients.”

Shire Plc., a Jersey-registered, Irish-headquartered global specialty bio-pharmaceutical company reported an annual sales of $714 million for this product in 2016 in the United States, reports the Economic Times.
Last updated: December 26th, 2025
