Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has filed an ANDA with the FDA seeking approval to market Mesalamine delayed-release tablets, 1.2g, a generic version of Shire’s Lialda.
The lawsuit was filed under the provisions of the Hatch-Waxman Act.
The suit results 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.