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Generic version of Plavix launched in US

Published on 10/08/06 at 12:09pm

A generic company has launched a version of blood-thinning blockbuster product Plavix in the US, threatening the $3.3 billion sales its co-marketers Sanofi-Aventis and Bristol-Myers Squibb earn there every year.

Plavix (clopidogrel) is a flagship brand for both companies, but a dispute over its US patent has now provided Canadian company Apotex with an opportunity to launch the first-ever generic version for a limited period.

Apotex's generic clopidogrel is likely to be removed from the market after just five days, but analysts say the launch of cheaper versions could ruin the market for Sanofi-Aventis and Bristol-Myers Squibb regardless of the final outcome.

The generic company could have further opportunities to sell clopidogrel as the legal wrangling is set to continue over the next few months.

In March, Sanofi-Aventis and Bristol-Myers Squibb struck a deal with Apotex to pay it not to market a rival version until 2011, but this arrangement was rejected by US regulators, giving Apotex the chance to launch an 'at risk' generic.

Peter Dolan, chief executive of BMS said it was considering its legal options with Sanofi-Aventis and pledged to fight the Apotex launch.

"This launch is called 'at risk' because it is occurring before the expiration of the patent on Plavix, and, as such, potentially subjects Apotex to pay damages should the court ultimately find that our patent is indeed valid and infringed," Dolan explained.

Dolan added that the marketing partners have contingency plans in place to mitigate the impact of the launch in a range of plausible scenarios but the company can only hope to limit the damage to its share of Plavix sales, which represent up to 30% of the company's profits.

Barbara Ryan, analyst at Deutsche Bank has told the Financial Times she believes the events could force BMS to slash its shareholder dividend in half this year, and could even leave it open to a takeover bid.

Plavix also represents 10-15% of Sanofi's earnings, and is facing generic competition against other drugs. The company is suing Sandoz (the generic arm of Novartis) to stop the launch of a generic version of anti-thrombosis drug Lovenox in the US.

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