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Sanofi fined for slamming Plavix generics

Faces €40.6m penalty for telling doctors generic copies were not suitable substitutes for blockbuster antiplatelet drug

Sanofi reception

France's antitrust authority has fined Sanofi €40.6m ($53m) for telling doctors that generic copies of its blockbuster antiplatelet drug Plavix (clopidogrel) were not suitable substitutes for its own brand.

The penalty comes after an investigation into Sanofi's conduct by France's l'Autorité de la Concurrence, which in turn was prompted by a complaint by generic rival Teva. Sanofi has said it is already preparing an appeal of the ruling.

In a statement, the competition authority says that Sanofi embarked on a "strategy of denigration" against generic clopidogrel in a bid to limit their entry into the market and favour Plavix and its own-brand generic Clopidogrel Winthrop.

The first generic competitors to Plavix appeared on the French market in October 2009, and it is alleged that Sanofi immediately tried to influence doctors to write on prescriptions for Plavix that they were "not suitable for substitution" by a generic.

The pharma company also targeted pharmacies dispensing the drugs, encouraging them to substitute Plavix for Clopidogrel Winthrop in favour of competing generics, it says.

The generic companies launched products using a different salt to Plavix, which is based on clopidogrel bisulfate and was under patent protection in France until February of this year.

Company representatives used this difference to suggest that generics based on clopidogrel hydrochloride or clopidogrel besylate were not equivalent to the original product and – in some cases – imply that healthcare practitioners may open themselves up to liability claims if they were prescribed, claims the competition regulator.

In 2008, France's national health system spent €625m on the drug, more than any other pharmaceutical product, according to the statement.

However, the expected saving to the healthcare system from the arrival of generics in 2009 did not occur, coming in around €38m lower than expected because Plavix sales did not erode so quickly.

Clopidogrel Winthrop enjoyed "exceptional penetration", capturing a 34 per cent market share.

15th May 2013

From: Sales, Regulatory

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