Resources for Food and Drug Administration (FDA)

FDA: Don’t Do As We Say or You’re Out of Luck

www.patentbaristas.com

What happens when a brand name drug company asserts that a patent covers its drug and then pulls it out from the Orange Book? You fight to get it back in, that’s what.

In August, Teva Pharmaceuticals USA submitted a Citizen Petition pursuant to section 505 of the Food, Drug, and Cosmetic Act (FDCA) asking the FDA to do just that.

The FDA’s official Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book“) listed two patents as claiming Risperdal® tablets: U.S. Patent No. 4,804,663, which was set to expire on December 29, 2007, and U.S. Patent No. 5,158,952 (”the ‘952 patent”), which will expire on October 27, 2009. Risperidone is an antipsychotic medication sold by Janssen Pharmaceutica (a subsidiary of Johnson & Johnson) under the trade-name Risperdal®.

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