Boston, MA 06/05/2014 (wallstreetpr) – Mylan Inc (NASDAQ:MYL) settles the patent litigation with Pfizer relating to the generic version of Celebrex. The Company filed the Abbreviated New Drug Application (ANDA) with the FDA for Celebrex capsules. The product primarily uses for the treatment of arthritis and pain management in adults.
Celebrex’s patent will expire by May 30, 2014 and several generic drug makers filed for ANDA with the FDA. Pfizer entered into settlement agreements with few companies including Mylan Inc (NASDAQ:MYL) and grant the licenses to sell the generic Celebrex in the U.S.
As per the settlement agreement, Mylan will sell generic Celebrex at the earliest, but not before December 2014. The Federal Trade Commission (FTC) and Department of Justice needs to review the agreement.
Mylan Inc (NASDAQ:MYL) also appealed for a decision in the U.S. district court for denying the Company’s request for a ban in its suit against the FDA. The Company believes that the FDA can’t give the exclusive authority of 180 days to one party on Celebrex and will continue with the legal action till to get a complete settlement.
Why Celebrex So Important For Pfizer
According to the IMS Health, Celebrex had sales of ~$2.34 billion in last 12 months ended March 31, 2014. But, Celebrex’s sales started falling with the advent of patent expiry and the U.S. sales were down by 5% to $402 million compared to prior year period and represented 10% of total biopharmaceutical revenue of the U.S. Pfizer expects to report lower sales in the coming quarters.
Mylan’s Gain Over Generic Celebrex
Mylan Inc (NASDAQ:MYL) has a wide range of low-cost products with more than 1,300 generics and branded medicines and has a strong presence and operates in more than 140 countries. So the availability of generic Celebrex will serve a large population suffering from arthritis and pain at an affordable cost.