ARTICLE | Company News

Teva, Actavis, Mylan, Pfizer gastrointestinal news

May 5, 2014 7:00 AM UTC

Mylan filed suit against FDA in the U.S. District Court for the Northern District of West Virginia challenging an April 24 decision by the agency on marketing exclusivity of a generic version of Celebrex celecoxib, a pain and autoimmune drug from Pfizer. In its suit, Mylan alleges it and other companies that submitted a Paragraph IV notification on March 7, 2013, are entitled to share the 180 days of marketing exclusivity with Teva, which was granted exclusivity of its generic version of the drug beginning May 30 - when pediatric exclusivity expires. Mylan asserts that it is entitled to share exclusivity because it submitted its Paragraph IV notification to Pfizer's reissued U.S. Patent No. RE44048 covering Celebrex on March 7, 2013 - the day the patent was listed in the Orange Book. In its April 24 decision, FDA interpreted the reissue patent and the original U.S. Patent No. 5,760,068 as a "bundle of rights" and treated as one and the same, according to Mylan's suit. Thus, Teva is eligible for 180 days of market exclusivity because it was the first filer of an ANDA for celecoxib on or about Nov. 11, 2003. Mylan is seeking an order compelling FDA to grant market exclusivity to Mylan and any other first-filers to the '048 reissue patent.

Separately, on April 24, Pfizer and Actavis settled all outstanding patent litigation regarding Celebrex. Pfizer granted Actavis rights to launch its generic version beginning in December or earlier under certain undisclosed circumstances. On April 28, Actavis filed suit against FDA in the U.S. District Court for the District of Columbia alleging the agency improperly awarded 180-day market exclusivity to Teva for its generic. ...