Andrx Granted Final Judgment for Naprelan
FORT LAUDERDALE, Fla., Mar 15, 2002 (BUSINESS WIRE) -- ANDRX CORPORATION -- Andrx Group (Nasdaq: ADRX chart, msgs) today announced that Judge Adelberto Jordan of the United States District Court for the Southern District of Florida has issued an order of final judgment in favor of Andrx that the patent which covers Elan Corporation's Naprelan(R) product (U.S. Patent No. 5,637,320) is invalid. Naprelan is a controlled release naproxen sodium product marketed for the treatment of pain caused by arthritis, osteoporosis and other inflammatory conditions. According to IMS data, Naprelan generated 2001 brand sales of approximately $30 million.
Andrx filed an abbreviated new drug application (ANDA) for its bioequivalent version of the 500-mg strength of Naprelan in July 1998 and its ANDA for the 375-mg strength in May 2000. Elan commenced patent infringement litigation against Andrx in 1998, within the 45-day period following Elan's receipt of Andrx's notice that its ANDA product did not infringe the '320 patent or that the patent was invalid. Andrx received tentative FDA approval for its Naprelan ANDAs in July 2001. Final marketing approval is subject to the resolution of certain legal issues involving the exclusivity rights, if any, of a Naprelan ANDA, which was filed earlier by Brightstone Pharma, Inc. Andrx maintains that Brightstone's exclusivity rights ended with Brightstone's consent judgment that its ANDA infringes the patent rights of Elan. Accordingly, FDA presently has the authority to approve the Andrx Naprelan ANDAs. FDA has not yet made a final determination with respect to this issue.
Commenting on the news, Elliot F. Hahn, Ph.D., Chief Executive Officer and President of Andrx, stated: "Having fought and yet again prevailed in the courtroom, we hope that, with the help of FDA, we soon will be able to market these more affordable versions of Naprelan to consumers."
Andrx Corporation is a specialty pharmaceutical company engaged in the formulation and commercialization of oral controlled-release generic and brand pharmaceuticals utilizing its proprietary drug delivery technologies. |
