Mylan Confirms Favorable Ruling In Generic Celebrex Patent Suit - Quick Facts

(RTTNews) - Mylan Inc. (MYL) confirmed that the United States District Court for the Eastern District of Virginia has ruled invalid a patent, United States Patent No. RE44,048, related to Pfizer's (PFE) Celebrex (celecoxib) 50 mg, 100 mg, 200 mg and 400 mg capsules.

Mylan was sued by G.D. Searle LLC and Pfizer Asia Pacific PTE, Ltd. for alleged infringement of this patent in connection with Mylan's Abbreviated New Drug Application or ANDA for its generic version of Celebrex.

Mylan said it expects to launch its generic version of Celebrex in May 2014, pending final approval of its ANDA by the U.S. Food and Drug Administration (FDA). Based on available information, Mylan believes it may be entitled to 180 days of shared generic market exclusivity on the 100 mg, 200 mg and 400 mg strengths, subject to the FDA's determination that the product qualifies for an award of exclusivity under the provisions of the Hatch-Waxman Act.

Celebrex is indicated for the treatment of osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute pain and primary dysmenorrhea. For the 12 months ended December 31, 2013, Celebrex had total U.S. sales of approximately $2.2 billion.