Appellate Court Confirms That Andrx ANDA For Tiazac Does Not Infringe Patent; Timing of Generic Availability Depends on Review of Recent Biovail's Actions

Business Wire, Feb 14, 2001

Business Editors/Health & Medical Writers

FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Feb. 14, 2001

Andrx Corporation (Nasdaq:ADRX) today announced that the United States Court of Appeals for the Federal Circuit affirmed the district court's earlier determination that the product described in Andrx's abbreviated new drug application (ANDA) for Tiazac(R) does not infringe the patent claims of Biovail Corporation (NYSE:BVF) and its affiliates. However, and unfortunately for consumers, as a result of Biovail's delay tactics, Food and Drug Administration (FDA) approval of the marketing of this product has now been delayed by Biovail's listing of a recently issued patent that it contends "covers" Tiazac(R). Andrx believes that this listing is blatantly improper and is a clear abuse of the law intended to unlawfully extend patent protection over this product. Andrx has alerted both FDA and FTC authorities of this abuse and has commenced legal action to remedy the situation.

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 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 other variations thereof or comparable terminology are 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