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Drug partners sue maker of generic

NEW YORK -- Bristol-Myers Squibb Co. and Sanofi-Aventis SA said yesterday they filed an injunction against Apotex Corp. to stop the Canadian drug maker from selling a less expensive generic version of the blood thinner Plavix. They also said they have begun discounting Plavix to stem the loss of the drug's market share.

A hearing on the motion is set for Friday in the US District Court for the Southern District of New York, where the injunction was filed and a patent case on Plavix is pending.

In the filing, the two brand-name makers cited four reasons the injunction should be issued, including the likelihood that they will prevail in the patent case and that Apotex's launch last week is causing them irreparable harm.

Apotex launched the drug a week ago after a settlement agreement to end the years-old patent litigation fell apart. The generic drug retails for around $124 for 30 tablets, compared with about $148 for the branded version. However, in the filing the companies said they had initiated a program to give large rebates to companies that continue to purchase Plavix. The documents didn't outline the size of the rebates.

In late July, the Justice Department launched a criminal investigation into an out-of-court settlement among Apotex, Bristol-Myers, and Sanofi-Aventis where the two brand-name makers had agreed to pay Apotex a minimum of $40 million to keep its version of the drug off the market until 2011. Plavix's patent expires in 2011, but under the agreement the two brand-name makers would allow Apotex to launch its drug several months early.

FBI agents with a search warrant confiscated documents at Bristol-Myers' New York headquarters, and both companies received grand jury subpoenas to determine if the agreement broke antitrust laws. The deal between the drug companies was rejected by state attorneys general, who must approve arrangements between Bristol-Myers and generic drug makers as a result of earlier litigation.

Sales of Plavix, the world's second-best selling drug behind Pfizer Inc.'s cholesterol drug Lipitor, totaled about $5.9 billion last year.

Representatives at privately held Apotex were not available for immediate comment.

Plavix is a Sanofi-Aventis medicine, but under an agreement Bristol-Myers sells it in the United States, Canada, and several other countries. The medicine is Bristol-Myers' best selling product, and is considered crucial for the company to maintain its dividend and earnings outlook.

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