Watson Pharmaceuticals, Inc. confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market Mesalamine delayed-release tablets, 1.2g. Watson's ANDA product is a generic version of Shire Development LLC's Lialda.
Shire Development LLC, Shire Pharmaceutical Development Inc., Cosmo Technologies Limited, and Guiliani International Limited filed suit against Watson on May 8, 2012, in the United States District Court for the Southern District of Florida seeking to prevent Watson from commercializing its ANDA product prior to the expiration of US Patent No. 6,773,720. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months from the date the plaintiffs received notice of Watson's ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
For the twelve months ending March 31, 2012, Lialda had total US sales of approximately $390 million according to IMS Health data.
Watson Pharmaceuticals, Inc. is an integrated global specialty pharmaceutical company. The company is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on urology and women's health.