On June 19, 2007, the U.S. District Court for the Southern District of New York upheld the validity and enforceability of the U.S. patent covering clopidogrel bisulfate, the active ingredient of Plavix(R), and issued a permanent injunction enjoining Apotex from marketing its generic clopidogrel bisulfate in the United States prior to the expiration of the patent. Apotex had launched a generic clopidogrel bisulfate in August 2006, following which the U.S. District Court for the Southern District of New York awarded sanofi- aventis a temporary injunction on August 31, 2006 ordering Apotex to halt further sales of its generic clopidogrel bisulfate, without however ordering a recall of products already shipped. The main patent protection for this product has now been maintained in the United States until November 2011.
In the United States, sales of Plavix(R) (consolidated by BMS) reached $1,180 million in the fourth quarter, compared with $348 million in the fourth quarter of 2006 when the product was affected by the availability of a generic version. Full-year sales of Plavix(R) totaled $4,072 million, compared with $2,672 in 2006.
In Europe, fourth-quarter net sales of Plavix(R) were 5.0% higher at euro 458 million, though sales are still affected by parallel imports in Germany.
In the "Other Countries" region, sales growth is accelerating, reaching 27.8% in the fourth quarter (to euro 225 million), driven by the product's success in Japan where the pace of sales growth was boosted in May by the decision of the authorities to lift the two-week limit on prescriptions. Fourth quarter sales in Japan were euro 27 million, against euro 4 million in the comparable period of 2006. Over the full year, Plavix(R) recorded Japanese sales of euro 61 million, compared with euro 11 million in 2006.
(1) See Appendix 1 for a definition of financial indicators, and
Appendix 6 for a description of selecte
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