Generic Plavix Hits the Shelves, Temporarily?

Pharmacy Times
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In what has been viewed as a classicDavid-vs-Goliath move, theCanadian generic drug makerApotex Inc began shipping a cheaperform of Bristol-Myers Squibb Co (BMS)and sanofi-aventis' (SA) Plavix (clopidogrelbisulfate) in early August. Pricesfor the generic in the United States areabout 30% lower than the $4-a-dayregular retail price for Plavix.

The move by Apotex came after the USgovernment's recent rejection of a proposedpatent settlement by the 2 majorpharmaceutical manufacturers that wasmeant to block generic competition forPlavix for years. As a result of the rejection,Apotex advised BMS and SA that itwas terminating its obligation to pursuethe settlement.

BMS and SA sought to block the introductionof generic Plavix after Apotexhad received FDA approval to begin marketinga generic version of the $6-billiona-year blood-thinning drug earlier thisyear. The lawsuit alleged that Apotex'sversion violated BMS and SA's originalpatents for the drug. Before the casecould go to trial, however, a settlementwas reached under which Apotex reportedlyreceived $40 million in return for anagreement not to begin marketing itsgeneric Plavix until September 2011.Under the agreement, the major companiesagreed to wait 5 days beforerequesting an injunction on the sales ofclopidogrel by Apotex.

In the event that Apotex launched itsgeneric version of Plavix "at risk," BMSand SA waived their rights to claim up to3 times their lost sales in damages if theywin the patent challenge against Apotex.Instead, their damages would bebetween 40% and 50% of Apotex's netsales from the drug.

BMS and SA filed an injunction withthe US District Court to halt sales ofgeneric Plavix and to have all alreadyshippedproduct recalled. On August 31,the court granted their request to stopfurther distribution of Apotex's product,but denied the request for a recall.Retailers and mail-order prescriptioncompanies have already purchased atleast a 6-month's supply of genericPlavix; the ruling allows them to use it tofill prescriptions until the supply runs out.

Apotex has filed an emergency motionwith the Court of Appeals for the FederalCircuit to stay the injunction, according toa spokesman for the company.The court'sorder is a preliminary injunction which willremain effective until the patent suit inNew York state concludes or until Apotexwins an appeal. BMS and SA wereordered by the court to put up a $400 millionbond in the event Apotex does win.

Apotex's founder and chief executiveofficer, Barry Sherman, predicted that itsintroduction of clopidogrel, the biggestsellingdrug ever to go generic, wouldmark the "largest and most successfullaunch" of a generic drug in history." Heinsisted that "the patent will be heldinvalid" and that the decision was "firstand foremost a blow to consumers,patients, taxpayers, and businesses." Hesaid he was convinced that the agreementBMS and SA had made was illegal,because it was in violation of a promisethat BMS had made to the FTC in 2003,stating that it would not settle patentsuits with generic firms by offering anythingof value for 10 years.

Plavix, BMS' biggest product and SA'ssecond biggest, is the world's secondbest-selling drug (after Pfizer's Lipitor[atorvastatin calcium]), with sales ofabout $5.9 billion in 2005. According toIMS Health, the typical loss expectedwhen a generic version of a drug hits themarket is 90% of the branded version'ssales within the first 3 months.

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