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Andrx Granted Final Judgment for Naprelan.


Business Editors/Legal, Health & Medical Writers

FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--March 15, 2002

ANDRX CORPORATION -- Andrx Group (Nasdaq:ADRX ADRX Andrx Corporation (stock symbol) ) today announced that Judge Adelberto Jordan of the United States District Court for the Southern District of Florida The United States District Court for the Southern District of Florida (S.D.Fl.) is the federal district court covering the southern part of the state of Florida. The court's jurisdiction comprises the following counties: Broward, Dade, Highlands, Indian River, Martin, Monroe,  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 (1) See IP Multimedia Subsystem.

(2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS.
 data, Naprelan generated 2001 brand sales of approximately $30 million.

Andrx filed an abbreviated new drug application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar  (ANDA ANDA
abbr.
abbreviated new drug application
) for its bioequivalent bi·o·e·quiv·a·lent
n.
A value indicating the rate at which a substance enters the bloodstream and becomes available to the body.
 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 An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called 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 FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 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.

Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. For this purpose, any statements contained in this report that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative or other variations thereof or comparable terminology is intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risks and uncertainties, including those risks and uncertainties detailed in the Company's filings with the Securities and Exchange Commission.

This release and additional information about Andrx Corporation are also available on the Internet at: http://www.andrx.com
COPYRIGHT 2002 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Mar 15, 2002
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