Biovail Confirms Receipt of Notification of ANDA Submission for Wellbutrin XL

Business Wire, Nov 17, 2004

TORONTO -- Biovail Corporation (NYSE:BVF)(TSX:BVF) today confirmed that it has received notification that an abbreviated new drug application (ANDA) has been submitted to the U.S. Food and Drug Administration (FDA) by Anchen Pharmaceuticals, Inc., seeking marketing approval for 150mg and 300mg generic formulations of Wellbutrin XL(R) (once-daily bupropion). At the present time, it is not known if the ANDA submission has been accepted for review by the FDA.

In accordance with the relevant regulations, Biovail has a 45-day period in which to analyze the submission and determine if the intellectual property protecting Wellbutrin XL(R) has been infringed. If a legal patent infringement suit is commenced within 45 days from receipt of the Notice of Non-Infringement, pursuant to the provisions of the Hatch-Waxman legislation, the FDA cannot approve the generic product for up to a period of 30 months or upon a Court decision of non-infringement -- whichever is earlier. In the event that the formulation is found to be infringing, a permanent injunction will be sought precluding the launch of the product permanently.

Wellbutrin XL(R) tablets incorporate Biovail's Smartcoat(TM) technology and have a two-layer coating designed to release drug slowly in the body. The patent estate protecting Wellbutrin XL(R) consists of two formulation patents (U.S. patent numbers 6,143,327 and 6,096,341) listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations database (commonly referred to as the Orange Book). These two formulation patents are valid until 2018. A third patent, which would further strengthen Wellbutrin XL's(R) intellectual property position, is currently under accelerated review by the U.S. Patent and Trademark Office. Biovail anticipates the issuance of this new patent by mid-2005.

"We are confident in the strength of our intellectual property rights as they relate to Wellbutrin XL(R), and will defend these vigorously," said Dr. Douglas Squires, Biovail's Chief Executive Officer.

Biovail continues to develop a new and improved formulation of Wellbutrin XL(R). Biovail is targeting the initiation of relevant studies in the first half of 2005, which could lead to a submission to the FDA by the second half of 2005.

About Wellbutrin XL(R)

Wellbutrin XL(R) is the first and only once-daily norepinephrine dopamine reuptake inhibitor (NDRI) for the treatment of depression in adults. The active ingredient in Wellbutrin XL(R) -- bupropion hydrochloride -- is believed to act upon norepinephrine and dopamine, two chemicals in the brain known to help regulate different aspects of mood, cognition, and behavior. Imbalances in these brain chemicals are associated with depressed mood and other symptoms of depression. Bupropion has no clinically significant impact on serotonin, a third brain chemical involved in mood regulation.

Biovail developed Wellbutrin XL(R) and licensed the product's worldwide (excluding Canada) sales and distribution rights to GlaxoSmithKline (GSK) in October 2001. Under the terms of the agreement, Biovail manufactures and supplies all of GSK's trade and sample supply requirements. Biovail's supply price is based on a percentage of the GSK's net sales of Wellbutrin XL(R), with the price escalating as certain annual net sales thresholds are met. Biovail is responsible for the costs to manufacture the product.

About Biovail Corporation

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. For more information about Biovail, visit the company's Web site at www.biovail.com

For further information, please contact Ken Howling at 905-286-3000 or send inquiries to ir@biovail.com.

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To the extent any statements made in this release contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements on our current expectations and projections about future events. Our actual results could differ materially from those discussed in, or implied by, these forward-looking statements. Forward-looking statements are identified by words such as "believe", "anticipate", "expect", "intend", "plan", "will", "may" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. Forward-looking statements include, but are not necessarily limited to, risks and uncertainties, including the difficulty of predicting U.S. Food and Drug Administration ("FDA") and Canadian Therapeutic Products Directorate ("TPD") 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 and finished products, third parties, 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 ("SEC") and the Ontario Securities Commission ("OSC"). Biovail Corporation undertakes no obligation to update or revise any forward-looking statement.