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News Story
Biovail settles Wellbutrin patent-litigation case with four companies
By Krystle Chow, Ottawa Business Journal Staff
Mon, Mar 5, 2007 10:00 AM EST

Biovail Corp. has reached a comprehensive settlement with four pharmaceutical companies in a patent-litigation case involving its flagship antidepressant drug Wellbutrin XL.

The Mississauga-based company, whose chairman is Ottawa Senators' owner Eugene Melnyk, said the settlement was with Anchen Pharmaceuticals LLP, Impax Laboratories Inc., Watson Pharmaceuticals Inc. and Teva Pharmaceutical Industries Ltd.

The company said in a statement that it had launched the suit when "certain parties had filed abbreviated new drug applications seeking approval to launch generic formulations of Wellbutrin XL, prior to the expiry of its patents."

Biovail said its case against Impax and Watson would be dismissed, while Teva, Anchen and Impax would be granted an exclusive licence under Biovail's patent to market a generic version of the 300-mg strength of Wellbutrin XL from Dec. 13, 2006 until June 13 of this year, when the licence would become non-exclusive.

The company also granted Teva, Anchen and Impax an exclusive licence to market a generic version of the 150-mg strength Wellbutrin XL for a period of 180 days following market entry.

However, Biovail specified that outside of these exceptions, none of the four companies would be allowed to market their generic versions of the 150-mg strength of the drug until 2008.

Sales of Wellbutrin XL made up nearly half of Biovail's revenues in 2005. The company is expected to lose U.S. patent protection for the product sometime this year.

The company noted that its legal action against Abrika Pharmaceuticals LLP has not been affected by this settlement.

The company stated that it would be reassessing its financial guidance for 2007 and updating its forecast if necessary, "as the settlement will have a positive effect on Biovail's 2007 revenues for the Wellbutrin XL product line."

The updated guidance is scheduled to be released with Biovail's fourth-quarter and full-year 2006 earnings on March 15.


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