PRINCETON, N.J., Oct. 31 /PRNewswire/ -- Ranbaxy Laboratories Limited (Ranbaxy) announced today the status of issues relating to the 180-day exclusivities for two of the largest cholesterol-lowering agents marketed in the U.S. healthcare market.
Pravastatin 80 mg
In respect to exclusivity on Pravastatin 10, 20 and 40 mg tablets held by Teva Pharmaceuticals (Teva), as a result of an October 21, 2005 court decision, we expect that the U.S. FDA will likely reverse its decision that the 180-day exclusivity was triggered and had expired (assuming affirmance on appeal). As a consequence of such expected decision, it appears that Teva will have exclusivity for 10, 20 and 40 mg tablet strengths that will allow for commercialization at the time that the basic patent expires on April 20, 2006. Irrespective of the expected 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.
Simvastatin Matter
As anticipated, on October 24, 2005 the U.S. FDA denied Ranbaxy’s citizens 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 80 mg 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 80 mg strength tablet, and is thus entitled to market exclusivity for this particular strength. Prior to the U.S. FDA response, Ranbaxy had brought suit against the U.S. FDA on September 11, 2005 to resolve the exclusivity question. A hearing is expected in January, 2006.
According to Jay Deshmukh, Vice President, Global Intellectual Property for Ranbaxy, “We are delighted with the likely exclusivity relating to Pravastatin 80 mg 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. Ranbaxy’s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company’s foray into Novel Drug Delivery Systems has led to proprietary “platform technologies,” resulting in a number of products under development. The Company is serving its customers in over 100 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 46 countries and manufacturing operations in 7 countries.
Ranbaxy Laboratories Limited
CONTACT: Charles M. Caprariello, Vice President, Corporate Communications,of Ranbaxy Pharmaceuticals Inc., +1-609-720-5615; or Edwige Buteau,+1-212-994-7517, or Caroline Mozingo, +1-212-994-7560, both of RF BinderPartners Inc., for Ranbaxy Laboratories Limited
Web site: http://www.ranbaxy.com/
