Mylan today announced that its Indian subsidiary Matrix Lab has challenged Pfizer Inc.'s patents for its Vfend Tablets (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, with the filing of its Abbreviated New Drug Application (ANDA). 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. Consequently, Matrix's ANDA will be eligible for final approval as soon as regulatory review by USFDA is complete.
US5116844 (Expiry: Aug 11, 2009): Link (Covers composition)
US5364938 (Expiry: Nov 15, 2011): Link (Covers Voriconazole generically)
US5567817 (Expiry: May 24, 2016): Link (Covers Voriconazole specifically)
US5773443 (Expiry: Jan 25, 2011): Link (Covers Voriconazole generically)
Matrix submitted its ANDA on April 14, 2008, and believes it is the first company to submit a substantially complete ANDA containing a Paragraph IV certification, and will be entitled for 180 days generic exclusivity.
Vfend Tablets, a triazole antifungal agent was approved by USFDA on May 24, 2002, had annual U.S. sales of approximately $157 million for the 12 months ending June 30, 2008, for the noted strengths, according to IMS Health.
Currently, Mylan has 112 ANDAs pending FDA approval, 23 of which are potential first-to-file opportunities.
Ippharmadoc believes that Mylan will now file Declaratory Judgment (DJ) against the listed patents. (Biomedicine news Link)
US5116844 (Expiry: Aug 11, 2009): Link (Covers composition)
US5364938 (Expiry: Nov 15, 2011): Link (Covers Voriconazole generically)
US5567817 (Expiry: May 24, 2016): Link (Covers Voriconazole specifically)
US5773443 (Expiry: Jan 25, 2011): Link (Covers Voriconazole generically)
Matrix submitted its ANDA on April 14, 2008, and believes it is the first company to submit a substantially complete ANDA containing a Paragraph IV certification, and will be entitled for 180 days generic exclusivity.
Vfend Tablets, a triazole antifungal agent was approved by USFDA on May 24, 2002, had annual U.S. sales of approximately $157 million for the 12 months ending June 30, 2008, for the noted strengths, according to IMS Health.
Currently, Mylan has 112 ANDAs pending FDA approval, 23 of which are potential first-to-file opportunities.
Ippharmadoc believes that Mylan will now file Declaratory Judgment (DJ) against the listed patents. (Biomedicine news Link)
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