Apotex clopidogrel at-risk launch costs US$442 million

Generics/News | Posted 02/03/2012 post-comment0 Post your comment

Sanofi and Bristol-Myers Squibb (BMS) announced on 8 February 2012 that generic drugmaker Apotex had paid a whopping US$442 million in damages in the Plavix (clopidogrel bisulfate) patent infringement case against Apotex.


The payment, which follows the decision of the US Court of Appeals for the Federal Circuit in October 2011 upholding the payment of damages to sanofi and BMS by Apotex, represents the final phase of the Plavix patent litigation between the companies and Apotex which was initiated on 21 March 2002.

Sanofi and BMS were also awarded US$1.3 million in post-judgment interest and US$900,000 in costs in addition to the damages award.

Apotex launched its generic version of the blood thinner on 8 August 2006, following approval of its abbreviated new drug application in January 2006 by FDA. However, the Canada-based company was ordered to stop sales on 31 August 2012. Annual sales for clopidogrel 75 mg tablets in the US at that time were estimated at approximately US$3.3 billion.

The settlement represented half of Apotex’s net sales of generic clopidogrel, which totalled more than US$884 million, during the three-week period that its generic version was on the US market [1].

Sanofi and BMS announced that they were pleased that their intellectual property rights had been upheld and that Apotex has made reparation for the harm caused by the at-risk launch of a generic version of clopidogrel bisulfate in 2006.

Apotex CEO Dr Barry Sherman said at the time that the company had ‘launched this product at-risk because Apotex always strives to make quality, affordable generic medicines accessible to those who need them at the earliest possible time’.

Plavix’s US patent is set to expire on 17 May 2012, so Apotex may yet have time to recoup some of its losses, especially if its 180-day exclusivity from being the first to file with FDA still holds.

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1.  GaBI Online - Generics and Biosimilars Initiative. Apotex loses fight over Plavix patents [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Mar 2]. Available from: www.gabionline.net/Generics/News/Apotex-loses-fight-over-Plavix-patents

Source: Apotex, Sanofi

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