Ten generic versions of the anti-clotting drug clopidogrel (Plavix) were approved en masse by the FDA on Thursday, coinciding with the expiration of a key patent on the drug.
Two dosage forms for the generics were approved: 300 mg, produced by Gate, Mylan, and Teva; and 75 mg, manufactured by Apotex, Aurobindo, Mylan, Roxane, Sun Pharma, Teva, and Torrent.
Clopidogrel is approved for secondary prevention of heart attacks and stroke in patients who have recently suffered such events, and for patients with peripheral artery disease.
The drug was the focus of a bungled "pay-for-delay" deal involving Apotex and the brand-name drug's maker, Bristol-Myers Squibb.
BMS and its European partner, Sanofi, made a secret deal with Apotex in 2006 to delay launching a generic form of clopidogrel. U.S. authorities determined that the agreement was illegal and BMS ended up paying some $3 million in fines.
Apotex suffered as well -- when the deal unraveled later in 2006, it immediately began shipping its generic clopidogrel, only to be found guilty of patent infringement. Earlier this year, it was forced to pay $445 million to BMS and Sanofi.
Apotex also forfeited the 6-month marketing exclusivity period normally granted to the first generic version of a branded drug to be approved (the FDA had initially approved it in January 2006 despite uncertainty over its patent status).
As a result, there is no exclusivity period for generic clopidogrel -- hence the simultaneous approvals given to the eight firms.
Bristol-Myers Squibb has set up a program that will keep patients' out-of-pocket cost of brand-name Plavix down to $37 per month through the end of this year.
After that, however, the firm will make little effort to protect the Plavix brand. According to Bristol's annual report for 2011, "We expect a rapid, precipitous and material decline in Plavix net sales" after generic products reach the market.