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Aventis sues generic rivals over Lovenox

Published on 29/10/03 at 10:21am

Aventis has gone to court in the US to prevent generic versions of its second-biggest drug, blockbuster anti-thrombotic treatment Lovenox, coming to market.

At the end of June Amphastar Pharmaceuticals and Teva Pharmaceuticals USA both submitted applications to the FDA to bring out separate generic versions of the drug.

The companies are seeking to show that one of Aventis' patents for Lovenox, not due to expire until 2012, is either invalid, unenforceable or would not be infringed by their proposed generic products.

Last month Amphastar filed an additional challenge on the same grounds to another of Lovenox's patents, which Aventis said was not due to expire until December 24, 2024.

Aventis said its view was that generic competition for Lovenox was "neither certain nor imminent."

Even if the pharma company were not challenging the productsapproval, generic applications of this kind take an average of 25 months to be cleared, according to an FTC report last year.

With Aventis heading for the courts, the company is entitled to an automatic 30-month block on FDA approval of the proposed products, that will only be cut short if it loses its courtroom battles with the generic companies.

Last year Lovenox, which is marketed in the UK as Clexane, increased its sales on the previous year by 13% to $1.7 billion.

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