Innovator Pfizer announced (in a press release Here) that it has entered into an agreement with generic player Mylan relating to a generic version of antifungal formulation Vfend (Voriconazole: (2R,3S)-2-(2,4-difluorophenyl)-3- (5-fluoropyrimidin-4-yl)-1- (1H-1,2,4-triazol-1-yl) butan-2- ol) 50 mg and 200 mg tablets. The agreement is limited to the tablet form of Voriconazole and does not cover Pfizer’s Voriconazole products for intravenous use or oral suspension.
The following patents are listed in Orange Book:
US5116844 (Expiry: Aug 11, 2009): which covers composition
US5364938 (Expiry: Nov 15, 2011): Covers Voriconazole generically
US5567817 (Expiry: May 24, 2016): Covers Voriconazole specifically
US5773443 (Expiry: Jan 25, 2011): Covers Voriconazole generically
Earlier, first Para IV filer, Matrix submitted its ANDA on April 14, 2008, as reported earlier by IP Pharma Doc Here. Importantly, Pfizer did not file a lawsuit against Matrix within the 45-day time period provided by the Hatch-Waxman Act to initiate an automatic stay of regulatory approval.
Voriconazole 50 mg and 200 mgTablets (Vfend) was approved by USFDA on May 24, 2002.
Pursuant to the agreement, Mylan will have the right to market voriconazole tablets in the United States in the first quarter of 2011. Additional details of the agreement with Mylan remain confidential. The agreement is subject to review by the U.S. Department of Justice and the Federal Trade Commission.
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