Generic Plavix Hits the Shelves, Temporarily?

Author: Wendy K. Bodine, Assistant Editor

In what has been viewed as a classic David-vs-Goliath move, the Canadian generic drug maker Apotex Inc began shipping a cheaper form of Bristol-Myers Squibb Co (BMS) and sanofi-aventis' (SA) Plavix (clopidogrel bisulfate) in early August. Prices for the generic in the United States are about 30% lower than the $4-a-day regular retail price for Plavix.

The move by Apotex came after the US government's recent rejection of a proposed patent settlement by the 2 major pharmaceutical manufacturers that was meant to block generic competition for Plavix for years. As a result of the rejection, Apotex advised BMS and SA that it was terminating its obligation to pursue the settlement.

BMS and SA sought to block the introduction of generic Plavix after Apotex had received FDA approval to begin marketing a generic version of the $6-billiona- year blood-thinning drug earlier this year. The lawsuit alleged that Apotex's version violated BMS and SA's original patents for the drug. Before the case could go to trial, however, a settlement was reached under which Apotex reportedly received $40 million in return for an agreement not to begin marketing its generic Plavix until September 2011. Under the agreement, the major companies agreed to wait 5 days before requesting an injunction on the sales of clopidogrel by Apotex.

In the event that Apotex launched its generic version of Plavix "at risk," BMS and SA waived their rights to claim up to 3 times their lost sales in damages if they win the patent challenge against Apotex. Instead, their damages would be between 40% and 50% of Apotex's net sales from the drug.

BMS and SA filed an injunction with the US District Court to halt sales of generic Plavix and to have all alreadyshipped product recalled. On August 31, the court granted their request to stop further distribution of Apotex's product, but denied the request for a recall. Retailers and mail-order prescription companies have already purchased at least a 6-month's supply of generic Plavix; the ruling allows them to use it to fill prescriptions until the supply runs out.

Apotex has filed an emergency motion with the Court of Appeals for the Federal Circuit to stay the injunction, according to a spokesman for the company.The court's order is a preliminary injunction which will remain effective until the patent suit in New York state concludes or until Apotex wins an appeal. BMS and SA were ordered by the court to put up a $400 million bond in the event Apotex does win.

Apotex's founder and chief executive officer, Barry Sherman, predicted that its introduction of clopidogrel, the biggestselling drug ever to go generic, would mark the "largest and most successful launch" of a generic drug in history." He insisted that "the patent will be held invalid" and that the decision was "first and foremost a blow to consumers, patients, taxpayers, and businesses." He said he was convinced that the agreement BMS and SA had made was illegal, because it was in violation of a promise that BMS had made to the FTC in 2003, stating that it would not settle patent suits with generic firms by offering anything of value for 10 years.

Plavix, BMS' biggest product and SA's second biggest, is the world's second best-selling drug (after Pfizer's Lipitor [atorvastatin calcium]), with sales of about $5.9 billion in 2005. According to IMS Health, the typical loss expected when a generic version of a drug hits the market is 90% of the branded version's sales within the first 3 months.