Fourth Circuit Rejects Another Authorized Generics Challenge

Law360, New York (July 19, 2006, 12:00 AM EDT) -- Following the lead of the Court of Appeals for the D.C. Circuit, the Fourth Circuit Court of Appeals has rejected the latest court challenge to the practice of authorized generics, in which a brand pharmaceutical company, after the first generic version of its brand-name product hits the market, licenses a second company to market a generic version of the brand product.

In its July 5, 2006 decision, the Fourth Circuit upheld the Food & Drug Administration’s July 2004 decision in which FDA determined that it lacks...
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