Hi-Tech files for decision on drug exclusivity
By
Associated Press
August 28, 2008
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Generic drug developer and nutritional products company Hi-Tech Pharmacal Co. said Thursday it asked a district court to rule that it is eligible for 180 days of market exclusivity for a generic version of Merck's glaucoma treatment Cosopt.
The company filed a complaint with the U.S. District Court for the District of Columbia against the Food and Drug Administration requesting a declaratory judgment related to its application for generic Cosopt. Specifically, the company wants confirmation that it was the first to ask for approval of a generic version, entitling it to 180 days of market exclusivity. The company also wants an injunction against the sale of other generic versions during that exclusivity period.
Hi-Tech shares added 2 cents to $9.40 in afternoon trading. Shares of Whitehouse Station, N.J.-based Merck rose 57 cents to $36.30.