Schering-Plough Files Patent Infringement Lawsuit Against GeoPharma Inc Over Generic Version of Clarinex(R)
On June 21, 2006, Belcher submitted its Abbreviated New Drug Application (ANDA) filing with the U.S. Food and Drug Administration, and included a "Paragraph IV" certification under the Hatch-Waxman Act, certifying that Belcher believes its proposed generic version of Clarinex tablets do not infringe Schering's patents listed in the FDA's "Orange Book" or that the listed patents are invalid or unenforceable.
The Hatch-Waxman Act provides for a 180 day period of exclusivity to one or more proposed generic manufacturers that are the first to file an ANDA with a Paragraph IV certification, and prevail in the litigation.
Source: GeoPharma
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