Watson seeks approval for generic ulcerative colitis drug

Shire, alleging patent infringement, files suit over generic Lialda

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals is hoping to be the first to market a generic version of a drug used to treat ulcerative colitis, the company said.

Watson announced that it had filed with the Food and Drug Administration through a subsidiary for melamine delayed-release tablets, a generic version of Shire Development's Lialda, in the 1.2-g strength. Watson's filing included a Paragraph IV certification, a legal assertion that Lialda's patent protection is invalid, unenforceable or won't be infringed.

In response, Shire and two other companies filed suit against Watson in the U.S. District Court for the Southern District of Florida seeking to prevent Watson from commercializing its drug, alleging that it infringes U.S. Patent No. 6,773,720, which expires in June 2020, according to the FDA. Under laws governing generic drugs, the lawsuit puts a stay of final FDA approval on Watson's drug for up to 30 months or until the companies settle.

Lialda had sales of about $390 million during the 12-month period ended in March, according to IMS Health.


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