A federal judge has ordered the manufacturer of generic clopidogrel to stop selling the product but not to recall the stock that remains in pharmacies, which, according to the ruling, had been used to fill almost 80% of clopidogrel prescriptions.
On Aug. 31, the U.S. District Court for the Southern District of New York granted the motion filed by Sanofi-Aventis requesting a preliminary injunction that prohibits the Canadian generic manufacturer, Apotex Inc., from selling its generic formulation of clopidogrel, until a patent infringement case filed against Apotex is resolved. The court, however, did not order Apotex to recall the generic clopidogrel product that has already been distributed.
In early August, Apotex launched its generic clopidogrel amid patent litigation with marketers of clopidogrel (Plavix), Bristol-Myers Squibb Co. (BMS) and Sanofi-Aventis, and a federal investigation of the latter companies.
The generic clopidogrel was used to fill most prescriptions. BMS and Sanofi-Aventis moved for a preliminary injunction in U.S. District Court for the Southern District of New York ordering Apotex to halt sales and recall existing inventory, and a hearing was held on Aug. 18.
The court's opinion stated that Sanofi had “adequately demonstrated” that questions Apotex raised about the validity and enforceability of the clopidogrel patent were “without substantial merit” based on the evidence to date, and that Sanofi had “demonstrated a likelihood of success on the merits at trial.” The Court also ordered Sanofi and BMS to post a $400 million bond, as security for Apotex in case the final ruling favored the generic company. A trial date has been set for Jan. 22, 2007.
At the time of the hearing, one generic clopidogrel pill cost $1.10 less than the price of one Plavix pill before Apotex launched the generic, and 78.4% of all clopidogrel prescriptions were being filled with the generic product, according to the opinion. The document refers to testimony made at the hearing that there were 48 million people who used clopidogrel daily.