Andrx Announces Court Ruling in Its Favor; Authorizes Earlier FDA Approval of Andrx's Generic Tiazac.

Business Editors/Health & Medical Writers

FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Sept. 21, 2001

Andrx Corporation -- Andrx Group (Nasdaq:ADRX) announced today that Judge William P. Dimitrouleas of the United States District Court for the Southern District of Florida has entered an order authorizing the FDA to approve the Andrx abbreviated new drug application (ANDA) for its bioequivalent version of Tiazac(R), an extended-release diltiazem manufactured by Biovail Corporation.

The Court found that, having lost its initial patent infringement case against Andrx both in the lower court and on appeal, Biovail's actions with regard to changing the formulation of its own approved drug to come within a newly obtained patent "were done to impede or delay" generic competition for Tiazac, and that accepting Biovail's arguments "would lead to a potentially endless listing of patents to prolong FDA approval of a generic competitor." The Court therefore shortened to September 27, 2001, any statutory basis for the FDA's prior refusal to approve Andrx's generic product.

The Court also established a June 3, 2002, trial date for Andrx's federal antitrust claims with respect to Biovail's actions as well as any patent issues remaining to be tried. The Court did not make any decision on Andrx's other statutory-based arguments concerning the Hatch-Waxman Act or on the invalidity and non-infringement of the new patent, which Andrx believes is both invalid and not infringed by its product. As Biovail has already indicated that it will seek to appeal the Court's decision, Andrx may again raise those arguments, which the Court stated have some merit, during any appeal Biovail is permitted to pursue.

Andrx President, Elliot F. Hahn, Ph.D., commented, "We are pleased that the Court saw through Biovail's delay tactics and authorized the FDA to approve our product later this month. While we continue to believe that Biovail's patent is invalid and not infringed by our product, we intend to carefully evaluate how Andrx should proceed once final FDA approval is obtained."

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. This release and additional information about Andrx Corporation are also available on the Internet at: http://www.andrx.com

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 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.