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Diflucan generics approved

Executive Summary

Diflucan generics enter market July 29 following expiration of Pfizer's pediatric exclusivity. FDA approved 22 ANDAs for tablet, oral suspension and injection forms of fluconazole. Pfizer is marketing its own generic tablet and oral suspension through its Greenstone subsidiary. Because Pfizer's only "Orange Book" listed patent has expired, none of the ANDA filers will enjoy 180 days of marketing exclusivity. Ranbaxy's attempt to enter the market earlier was rebuffed by FDA and the courts (1"The Pink Sheet" May 10, 2004, In Brief)...

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Ranbaxy's ANDAs for Diflucan may not be approved until Pfizer's pediatric exclusivity expires in July, a federal appeals court ruled April 26. Ranbaxy sued FDA in January, seeking approval of its fluconazole ANDAs upon the original Jan. 29 expiration of Pfizer's patent. FDA asserted Ranbaxy's ANDAs could not be approved until Pfizer's six-month pediatric exclusivity extension expires July 29; a federal district court ruled in favor of FDA in March (1"The Pink Sheet" March 15, 2004, p. 29)...

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