Teva Says Gets Favorable Court Decision On Generic Celebrex Capsules

(RTTNews) - Israel-based generic drugmaker Teva Pharmaceutical Industries Ltd. (TEVA) said Friday that it has received a favorable court decision regarding its generic version of pharmaceutical giant Pfizer Inc.'s (PFE) blockbuster arthritis drug Celebrex. The company noted that it should now receive sole exclusivity for generic Celebrex capsules, or celecoxib.

According to Teva, the U.S. District Court for the Northern District of West Virginia denied a motion filed by another generic drug maker, Mylan Inc. (MYL). The court issued an opinion and order affirming a decision by the U.S. Food and Drug Administration or FDA under which Teva should receive sole 180-day "first-to-file" exclusivity for generic Celebrex 100, 200 and 400 mg capsules.

Mylan said in late April that it filed a lawsuit against the FDA, challenging the agency's decision regarding generic drug marketing exclusivity on Celecoxib capsules, the generic version of Pfizer's Celebrex.

The FDA had issued a decision holding that eligibility for 180 days of exclusivity was 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. This was despite an earlier appellate court decision that held the original patent invalid, and a subsequent decision holding the reissued patent invalid.

Mylan believed that the FDA seriously erred in its decision in this case, and maintained that it was in a position to receive final approval on May 30, upon expiration of Celebrex's remaining patents. Teva had settled for a December 2014 launch date and would thus be unable to launch on May 30.

In mid-April, Teva entered into a settlement agreement with Pfizer related to its generic version of Celebrex 50, 100, 200 and 400 mg capsules in the U.S. Under the terms of that settlement, Teva may launch its generic versions in December 2014, or earlier under certain circumstances. The company received tentative approval from the FDA for all strengths of Celebrex.

Teva's deal with Pfizer came after a federal court had in March invalidated a patent that would have offered Pfizer an additional eighteen months of exclusivity and monopoly sales for Celebrex. The U.S. District Court for the Eastern District of Virginia ruled invalid a patent, U.S. Patent No. RE44048, related to Pfizer's Celebrex.

Celebrex is indicated for the treatment of osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute pain and primary dysmenorrhea. According to IMS data as of December 2013, Celebrex sales in the U.S. amounted to $2.2 billion.

TEVA is trading at $50.62, down $0.04 or 0.08 percent on a volume of 1.18 million shares.