Biovail Confirms Docket Posting of New Tiazac Patent in Orange Book.

Business Editors and Health/Medical Writers

TORONTO--(BW HealthWire)--Feb. 14, 2001

Available at http://www.fda.gov/cder/orange/docket.pdf

Comments on Tiazac(R) and Cardizem(R) Proceedings

Biovail Corporation (NYSE:BVF) (TSE:BVF) today confirmed that the docket listing of a newly issued patent (US Patent Number 6,162,463) which covers the Company's branded Tiazac(R) formulation has been posted on the Food and Drug Administration's website of Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. This listing may be viewed at www.fda.gov/cder/orange/docket.pdf. Biovail also provided the following comments with respect to various proceedings related to Tiazac(R) and its recently acquired Cardizem(R) franchise.

TIAZAC(R)

Biovail is the licensee of two patents relating to Tiazac(R), namely US Patent Number 5,529,791 ("the 791 patent") and US Patent Number 6,162,463 ("the 463 patent"). Both patents were listed with the FDA as required by the Waxman-Hatch Amendments to the Federal Food, Drug, and Cosmetic Act. The statute is straightforward and has protected the intellectual property rights of innovators during the generic drug approval process since 1984. In October 1998, Biovail and Andrx Group (Nasdaq:ADRX) engaged in patent litigation whereby Andrx asserted that the 791 patent was invalid and Biovail alleged that Andrx' product infringed. On March 6, 2000 the US District Court for the Southern District of Florida confirmed the validity of the 791 patent, however, it also found no infringement on the part of Andrx. Biovail appealed the Court's infringement decision and on February 13, 2001, the decision was affirmed.

On December 19, 2000, the new 463 patent was issued and licensed by Biovail. This patent was listed in the FDA Orange Book within the 30 day prescribed time period. 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(R) to also submit a Notice of Certification to Biovail on this patent. As a result, Biovail will consider whether such ANDA formulation infringes the 463 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 Waxman-Hatch provisions will be triggered and the ANDA owner will not be able to obtain final FDA approval for up to 30 months.

CARDIZEM(R) CD

On January 2, 2001 Biovail announced that it had entered into definitive agreements with Aventis Pharmaceuticals Inc. (Aventis) whereby Biovail had acquired for $409.5 million North American rights and benefits from the Cardizem(R) family of products. These rights and benefits included related intellectual property, patents, and made Biovail the legal beneficiary of all of the obligations of Andrx contained in the Stipulation and Agreement with Aventis. Specifically, that agreement contains obligations on the part of Andrx with respect to Cartia XT, Andrx' generic version of Cardizem(R) CD. As a result of preliminary testing to date, Biovail has given notice to Andrx that its Cartia XT product may be infringing the agreed upon dissolution specifications contained in the Stipulation and Agreement, and that Biovail will be vigilant in asserting its rights under that Agreement.

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.