Biovail Confirms FTC Settlement; Reaffirms Position of Proper Patent Listing.

Business Editors, Health & Medical Writers

TORONTO--(BW HealthWire)--April 23, 2002

Biovail Corporation (NYSE:BVF)(TSE:BVF) announces that it has entered into a formal settlement with the Federal Trade Commission ("FTC") with respect to FTC's investigation into the propriety of Biovail's actions relating to the listing of U.S. Patent No. 6,162,463 (the "'463 Patent") in the Food and Drug Administration's (FDA) Approved Drug Products With Therapeutic Equivalence Evaluations (commonly referred to as the "Orange Book") with respect to which Biovail had acquired exclusive rights.

The settlement with the FTC is evidenced by a Consent Agreement and proposed Consent Order which have been accepted by the Commission. The Settlement does not involve any payment by Biovail and therefore no negative financial consequences to the Company.

Biovail has maintained, and continues to maintain, that the acquisition of the exclusive rights to the patent in question and its subsequent listing in the Orange Book were and are proper and were made in accordance with the Hatch-Waxman Amendments. In particular, Biovail's position has always been that its listing of the patent in the Orange Book was not the reason for Andrx Group's ("Andrx") (NASDAQ:ADRX) failure to commercialize its generic version of Tiazac(R). Confirming this position, even following Biovail's termination of its patent infringement suit against Andrx and thereby eliminating any suggested regulatory or legal impediments, Andrx issued a press release on April 11, 2002 stating "The removal of the `463 Patent will not result in the immediate approval of the Andrx product as FDA has raised certain issues concerning Andrx's version of Tiazac(R)". Andrx has not indicated with any precision whether, or even if, its product will ever receive FDA approval.

As a result, the Consent Agreement with the FTC expressly provides that the amicable resolution of these issues is for "settlement purposes only" and that none of the FTC's allegations constitutes an admission by Biovail that it ever violated the law as alleged or at all.

The settlement further provides for a divestiture of Biovail's exclusive patent rights to the `463 Patent and also provides for the termination of its patent infringement suit against Andrx. "Biovail has terminated the legal action against Andrx but, contrary to FTC's suggestion that such would allow entry of generic Tiazac into the market, the dismissal of that suit has not resulted in the approval of Andrx's product. As Andrx has itself stated, Andrx must overcome serious issues raised by the FDA during the approval process before its product can be approved", stated Mr. Eugene Melnyk, Chairman and Chief Executive Officer.

The settlement also provides for an acceptable notification procedure to be followed with respect to Biovail's future acquisitions of patents for listing in the Orange Book for ANDAs which had already received prior approval.

"The settlement is particularly beneficial to Biovail because it ends the continued expenditure of legal expenses and adds certainty to Biovail's present legal positions without any undue erosion of Biovail's continued regulatory and patent strategies", commented Mr. Melnyk.

Biovail Corporation is a full-service pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, sale and promotion of pharmaceutical products utilizing advanced drug delivery technologies.

"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995.

To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission.