Apr 26 2014
Mylan Inc. (Nasdaq: MYL) today announced that it has filed suit against the U.S. Food and Drug Administration (FDA), challenging the agency's decision regarding generic drug marketing exclusivity on Celecoxib Capsules, the generic version of Pfizer's Celebrex®.
FDA issued a decision holding that eligibility for 180 days of exclusivity is only available to an applicant who first filed a PIV certification to an original patent and who then also made a timely PIV certification to a reissued patent, despite an earlier appellate court decision that held the original patent invalid, and a subsequent decision holding the reissued patent invalid.
Mylan believes that the FDA has seriously erred in its decision in this case, and maintains that it is in a position to receive final approval on May 30, upon expiration of Celebrex's remaining patents. Other companies, including Teva, have settled for a December 2014 launch date, and will be unable to launch on May 30.
Mylan CEO Heather Bresch commented: "We believe the FDA has made an unprecedented error in this case which clearly caught all industry participants off guard, as evidenced by some who have already settled with Pfizer for December 2014 launch dates, which is post patent expiry. Mylan seeks an order compelling FDA to grant final approval of Mylan's ANDA on May 30, 2014."