Andrx Relinquishes Exclusivity Rights to 150mg Generic Wellbutrin SR.Business Editors/Health/Medical Writers FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--March 22, 2004 Andrx Corporation (Nasdaq:ADRX ADRX Andrx Corporation (stock symbol) ) ("Andrx" or the "Company") announced today that it has relinquished its right to a 180-day period of marketing exclusivity for the 150mg strength of Wellbutrin SR(R) (bupropion hydrochloride bu·pro·pi·on hydrochloride n. A drug used to treat depression and nicotine dependence. bupropion hydrochloride Budeprion SR, Budeprion XL, Wellbutrin, Wellbutrin SR, Wellbutrin XL, Zyban ). As a result of this relinquishment, other companies who have submitted Abbreviated New Drug Applications 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 ("ANDAs") for this strength can receive 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 to market their products. Impax Corporation's ("Impax") ANDA ANDA abbr. abbreviated new drug application for this strength has now been approved, and Teva Pharmaceutical Industries Teva Pharmaceutical Industries Ltd. (Hebrew: טבע תעשיות פרמצבטיות בע"מ), NASDAQ: TEVA is an international pharmaceutical company headquartered in Ltd. ("Teva") has begun shipping this product. Under the Company's previously announced Exclusivity Transfer Agreement with Impax and a subsidiary of Teva, Andrx is entitled to a share of the profits derived from Teva's sale of this product for a 180-day period. The Company has not relinquished the 180-day period of marketing exclusivity pertaining to its ANDA for a 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 Zyban(R) (also bupropion hydrochloride). About Andrx Corporation Andrx Corporation is a pharmaceutical company that: develops and commercializes generic versions of controlled-release brand name pharmaceuticals, using the Company's proprietary controlled-release drug delivery technologies, and generic versions of niche and immediate-release pharmaceutical products, including oral contraceptives Oral Contraceptives Definition Oral contraceptives are medicines taken by mouth to help prevent pregnancy. They are also known as the Pill, OCs, or birth control pills. ; distributes pharmaceuticals, primarily generics, manufactured by others as well as manufactured by the Company, primarily to independent pharmacies, pharmacy chains, pharmacy buying groups and physicians' offices; and commercializes brand pharmaceuticals, in some instances using the Company's proprietary controlled-release drug delivery technologies. 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 herein or which are otherwise made by or on behalf 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," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative 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, including but not limited to the Company's dependence on a relatively small number of products; licensing revenues; the timing and outcome of patent, antitrust and other 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. ; the timing and commercial success of future generic product launches; whether the Company will be awarded any market exclusivity period and, if so, the precise dates thereof; government regulation generally; competition; manufacturing capacities, output and quality processes; the Company's ability to develop and successfully commercialize new products; the loss of revenues from existing products; development and marketing expenses that may not result in commercially successful products; the Company's inability to obtain, or the high cost of obtaining, licenses for third party technologies; commercial obstacles to the successful introduction of brand products generally, including Fortamet and Cardura XL; the success of the Company's joint ventures; the impact of returns, allowances and chargebacks; product liability claims; and the absence of certainty regarding the receipt of required regulatory approvals or the timing or terms of such approvals. Andrx Corporation is also subject to other risks detailed herein or detailed from time to time in its filings with the U.S. Securities and Exchange Commission. Andrx disclaims any responsibility to update the statements contained herein. This release and additional information about Andrx Corporation is also available on the Internet at: http://www.andrx.com. |
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