The US Food and Drug Administration has approved a generic version of Sanofi-Aventis and Bristol-Myers Squibb’s blockbuster drug Plavix made by Apotex, although the latter company has not yet decided whether it will launch the product.
Apotex said it was still discussing whether it would press ahead with a launch of Plavix (clopidogrel) in advance of the outcome of patent infringement litigation with B-MS and Sanofi-Aventis, which is due to come to trial in April.
The Canadian generics firm could reap huge rewards by launching early, but equally leave itself open to devastating damages if the patent case eventually goes in favour of B-MS and Sanofi-Aventis. A verdict in the court case might not be reached for up to a year.
Sales of Plavix reached $980 million for B-MS in the third quarter of 2005, while Sanofi-Aventis recorded revenues of 534 million euros ($656m) for the drug in the same period. Analysts estimate the product accounts for roughly 40% and 10% of the two companies’ profits, respectively. B-MS is due to report its fourth-quarter results later today.
Apotex maintains that it is free to launch the product because a patent issued for Plavix that would provide protection for the drug out to 2011 is invalid. Another patent on the drug expired in 2003 in the USA.