Patent Granted for Anti-inflammatory Drug Lumiracoxib

Novartis has received an Indian Patent No. 208639 for anti-inflammatory drug Lumiracoxib against the mail-box application no. 1927/MAS/1998 filed on August 27, 1998 claiming early priority from US provisional application dated August 28, 1997. In November 2006, Lumiracoxib, marketed as Prexige received marketing approval from all European Union countries through a common procedure called MRP, but later on December 13, 2007 the European Medicines Agency recommended the withdrawal for Prexige from all EU market. Earlier, on September 27, 2007, the US Food and Drug Administration issued a not approvable letter for Lumiracoxib, requiring additional safety data. Lumiracoxib, a COX-2 selective inhibitor is broadly covered within the markush compound structure described in the US Patent No. 6,291,523. The corresponding European Patent EP 1 007 505 already been granted Supplementary Protection Certificate in most of the contracting states, running exclusivity till September 2018. The drug is also recalled in Australia, New Zealand, Philippines, and Canada. In January 2006, Novartis received Drug Controller General of India (DCGI) approval to import and market Prexige, but later announced to drop marketing plans for Lumiracoxib in India due to the growing concerns about its adverse side effects.