Ranbaxy Laboratories Limited (Ranbaxy) clarified the status of issues relating to the 180-day exclusivities for two of the largest cholesterol-lowering agents marketed in the US healthcare market.
In respect to pravastatin 10, 20 and 40mg tablets held by Teva Pharmaceuticals (Teva), as a result of an October 21, 2005 court decision, the FDA will likely reverse its decision that the 180-day exclusivity was triggered and had expired, (assuming affirmance on appeal).
As a consequence of this decision, it appears that Teva will have exclusivity for 10, 20 and 40mg tablet strengths that will allow for commercialisation at the time that the basic patent expires on April 20, 2006. Irrespective of said decision and independent thereof, Ranbaxy ' s position is that it was the first to file a Paragraph IV certification for pravastatin 80 mg. and is thus entitled to exclusivity for this particular tablet strength when the product is launched by Ranbaxy, claims a company release.
As anticipated, on October 24, 2005 the US FDA denied Ranbaxy ' s citizen petition requesting the relisting of two patents that had been delisted for simvastatin tablets, or that it maintain its 180 day exclusivity until after it has commercially launched the 80mg tablet strength. Ranbaxy's position is that it believes it is the first company to file an ANDA containing a Paragraph IV certification against the 80mg strength tablet, and is thus entitled to market exclusivity for this particular strength. Prior to the US FDA response, Ranbaxy had brought suit against the FDA in Washington, DC on September 11, 2005 to resolve the exclusivity question. A hearing is expected in January 2006.
Jay Deshmukh, vice president, Global Intellectual Property for Ranbaxy said, " We are delighted with the situation relating to pravastatin 80mg tablets, and will now make our case regarding simvastatin. "
Ranbaxy Laboratories Limited, headquartered in India, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies.