Andrx Announces that AstraZeneca Claims to Have Listed Three Patents for Prilosec: More Orange Book Listing Abuses Seen.Business Editors/Health & Medical Writers FORT LAUDERDALE, Fla.--(BW HealthWire)--March 15, 2001 ANDRX CORPORATION (Nasdaq:ADRX ADRX Andrx Corporation (stock symbol) ) today announced that AstraZeneca (NYSE NYSE See: New York Stock Exchange :AZN AZN Asian ) claims to have listed in the United States Food and Drug Administration's (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. ) Orange Book three new patents as covering its Prilosec(R) product. Andrx has learned that the three "new" Prilosec(R) patents (Nos. 6,147,103, 6,166,213 and 6,150,380) were issued during the months of November and December 2000. Although the patents do not appear within the currently published Orange Book, AstraZeneca has stated that this non-listing resulted from a "mix-up" at FDA. Elliot Hahn, PhD., President of Andrx, said: "In the wake of numerous other newly issued patents relating to drugs which have been on the market for years, AstraZeneca's actions appear to be yet another attempt to abuse the Hatch-Waxman Act by delaying the advent of a cost effective generic alternative under the guise of protecting patent rights allegedly applicable to its product. By listing a newly issued patent in the Orange Book within 30 days of its issuance, brand companies claim they may delay final FDA approval of generic versions of their product for up to 30 additional months by initiating additional patent infringement patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver. 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. with respect to that patent. Andrx firmly believes that the listing of these patents should not be permitted to have that effect. It will undoubtedly be up to the courts or the regulators, and perhaps ultimately Congress, to remedy these abuses." Andrx believes that its generic version of Prilosec(R) does not infringe any of these new patents, and that these patents do not cover Prilosec(R), as currently being sold. Andrx has therefore notified federal regulators of this most recent listing abuse and intends vigorously to pursue its rights to enable FDA to approve the marketing of its generic version of Prilosec(R), as originally planned; following the expiration of the patent protection (April 5, 2001) and possible pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. exclusivity accorded omeprazole, the active ingredient of Prilosec(R). Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. 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 are intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risk and uncertainties. Andrx Group is a class of common stock of Andrx Corporation, therefore Andrx Corporation shareholders are subject to the risks and uncertainties described in Andrx Corporation's filings with the Securities and Exchange Commission, including Andrx Corporation's Annual Report on Form 10-K for the year ended December 31, 1999. This release and additional information about Andrx Corporation are also available at http://www.andrx.com. |
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