Celecoxib first Generic Approval to Teva and Mylan from FDA

On May 30, 2014, the U.S. Food and Drug Administration approved the first generic versions of Celebrex (celecoxib) capsules. Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 milligram, 100 mg, 200 mg, and 400 mg strengths, and has 180-day exclusivity on the 100 mg, 200 mg, and 400 mg strength products. Mylan Pharmaceuticals, Inc. received approval to market 50 mg celecoxib capsules.

Celebrex is a Pfizer’s blockbuster anti-inflammatory drug. Global sales of Celebrex exceeded USD2.1 billion, in the first nine months of 2013 which was a 13 percent increase on the same period the previous year.

Patent protection from US16059493A originally expiring in November 2013 in the US, paediatric extensions have extended the expiry of the molecule and composition patents, US 5,466,823 (‘823) and US 5,563,165 (‘165), a further six months, until May 2014. This was the primary hurdle for the companies wishing to develop generic equivalents.

Celecoxib is a selective COX-2 sulphonamide non-steroidal anti-inflammatory drug (NSAID), marketed by Pfizer, Pharmacia and G.D. Searle (both subsidiaries of Pfizer) under brand name Celebrex, Celebra for arthritis and Onsenal for polyps. It is indicated for use in the treatment of osteoarthritis, rheumatoid arthritis in patients 2 years or older, ankylosing spondylitis, acute pain and primary dysmenorrheal.