The U.S. Food and Drug Administration granted Cadila Healthcare Ltd. approval to market mesalamine delayed release tablets USP, 1.2 grams.
The drug is the first approved generic version of Shire PLC's Lialda, a treatment for mild to moderate ulcerative colitis, a type of chronic inflammatory bowel disease.
Estimated brand sales for mesalamine delayed-release tablets USP 1.2 g is $1.15 billion, per the IMS Health moving annual total as of April.
The generic will be manufactured at Cadila's Moraiya facility in Ahmedabad, India.
In May, the U.S. Court of Appeals for the Federal Circuit ruled that Zydus Pharmaceuticals (USA) Inc.'s generic version of Lialda does not infringe on Shire's patent.