Building on an increase in its earnings per share in 2009, Sanofi-Aventis has taken late April the precaution to indicate that the forecast agreed "barring major adverse events." The threat could not be limited to changes in foreign exchange, but come from a generic of Plavix. Sold in partnership with the American Bristol - Myers Squibb (BMS), this antithrombotic is the second best-selling world pharmacy, with a turnover of only $ 8.6 billion.
Sales that stir up the covetous of the manufacturers of generic drugs. "A dozen of records for copies of the product certification are currently in circulation at European level" indicates a good connoisseur of the sector. With objective to obtain an authorization for placing on the market this fall, or before the date of expiry of the patent of Plavix. Currently, the responses provided by the generics to questions from the European authorities (for example on the stability of the products, the bio-equivalence, etc.) are in training.

Association with another salt
In theory, Plavix is protected until November 2011 to 2013 in Europe and the United States and the Japan. But, on the old Continent, the active principle (the clopidogrel molecule) could be launched in association with another salt used by Sanofi-Aventis (hydrogen sulphate), to circumvent the problem of the patent. Thus, the Israeli Teva, world number one of generics, filed in July 2008 a folder in which the clopidogrel is associated with the hydrobromure. The group however withdrew its request last month for "strategic" reasons, believing that the data provided would not allowed him to obtain a positive opinion of the European authorities. Teva reserves the possibility of providing additional data. French Biogaran, subsidiary of the non-rated group Servier is also on the ranks, with a folder in which the clopidogrel is associated with the besylates.
Ranbaxy is not at rest. "Our record is under evaluation in some areas of Europe," confirms Anne Baille, the President of the French subsidiary of the group. Mylan generics in France leader, could launch its version of Plavix in 2010. Even more optimistic, Acino evokes a European approval for the third quarter of 2009. The Swiss group already sells its clopidogrel (associated with the besylates) in Germany since August. At end of March, he had picked up 24 of the German of Plavix market valued at EUR 400 million, according to his boss, Luzi Andreas von Bidder.
When questioned, Sanofi-Aventis considers that clopidogrel associated with the besylate is not wholly substitutable for the Plavix and its indication is more limited. "The indication Clopidogrel besylate in Germany represents less than half of the sales of plavix in this country," said a spokesman for the group. But the laboratory also acknowledges that "patents owned or licensed by the Group provide not always effective protection against a generic version of a competitor".
In the United States, Sanofi has already struggled against the Canadian manufacturer of generic drug company Apotex. Alongside of BMS, the French group won his trial on appeal in December. In this country, the issues are more important since the sales of plavix (consolidated by BMS) grew year last by 21 to 3.3 billion. In Europe, if the sword of Damocles by the end of the year, it will threaten four years of future sales.