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Plavix Facing Generic Challenge

Apotex is being sued for patent infringement by Sanofi-Aventis and Bristol-Myers Squibb.

The Food and Drug Administration on Tuesday said a Canadian company could sell a generic version of the anticoagulant Plavix, the biggest-selling drug for

Bristol-Myers Squibb

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However, it's unclear how fast the generic drug, made by


, would reach the U.S. market. Apotex is being sued for patent infringement by


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, the developer of Plavix and the marketing partner of Bristol-Myers Squibb.

The U.S. patent trial is scheduled to start April 3. Apotex could initiate a launch of generic Plavix, but if it loses the case, the penalties would be extensive. Earlier Tuesday, Sanofi-Aventis issued a brief press release, saying Plavix "continues to be protected by a valid patent."

The FDA made no formal announcement. Instead, the agency simply placed on its Web site, among all medication listings, the drug's generic name, clopidogrel bisulfate, the dosage strength and the generic-drug maker's name.

A courtroom defeat would hurt both Sanofi-Aventis and Bristol-Myers Squibb, who say the U.S. Plavix patent is valid until 2011. For the first nine months of 2005, Plavix produced $2.76 billion in sales for Bristol-Myers, or 19.5% of its revenue.

Plavix continues growing at a healthy rate, with sales attributable to Bristol-Myers up 17% for the first nine months of 2005 vs. the same period in 2004. The drug is designed to prevent blood platelets from clotting, thus reducing the risk of heart attack or stroke.

Last week, the companies asked the FDA to approve Plavix for acute ST-segment elevation myocardial infarction, a type of heart attack in which an artery is blocked long enough to damage the heart muscle. The companies also are seeking European Union approval for this expanded use.

Plavix is Sanofi-Aventis' second-biggest drug, recording sales of $1.85 billion, or 7.4% of its revenue, for the first nine months of 2005. For Sanofi-Aventis, Plavix revenue rose 21% from the same period in 2004.

Shares of Bristol Myers-Squibb, which will release its fourth-quarter and full-year financial report Wednesday, closed at $21.33, down 77 cents, or 3.5%. Sanofi-Aventis ended at $44.26, down $1.63, or 3.6%.