Biovail Confirms Tiazac Patent Listing in FDA Orange Book.

Business Editors, Health/Medical Writers

TORONTO--(BW HealthWire)--Jan. 30, 2001

Biovail Corporation (NYSE:BVF)(TSE:BVF.) today confirmed that a newly issued patent (U.S. Patent Number 6,162,463) that covers the Company's existing branded Tiazac formulation has been listed in the Food and Drug Administration's (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.

Biovail's Tiazac product, a once daily diltiazem medication prescribed for the treatment of hypertension and angina, is marketed by Forest Laboratories Inc. (NYSE:FRX) in the United States.

The effect of Biovail's listing of this Patent in the Orange Book is that the FDA will require every filer of an ANDA for a generic version of Tiazac to also submit a Notice of Certification to Biovail on this Patent. As a result, Biovail will consider whether such ANDA formulation infringes on its listed Patent and will have the legal right to commence a lawsuit against the owner of such ANDA. If Biovail determines to commence such suit within 45 days from receipt of the Notice of Certification, the Hatch Waxman provisions of the Food Drug and Cosmetic Act will be triggered and the ANDA owner will not be able to obtain final FDA approval for up to 30 months.

Biovail Corporation is an international 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.