Teva joins Amphastar in going for generic version of Aventis' Lovenox

Israeli drugmaker Teva has joined the US pharmaceutical firm Amphastar in applying to produce a generic copy of Aventis' blockbuster antithrombotic Lovenox/Clexane (enoxaparin) in the USA. Both companies have filed applications with the Food and Drug Administration, with Teva's coming on June 27, just a day after that of the US firm.

French drug industry analysts say the Teva application is by far the greater threat to Aventis, given the former's leading role in the world generics market. Lovenox posted sales of 1.56 billion euros ($1.79 billion) in 2002 and, for the first quarter of this year, saw turnover rise 10.6% to 389 million euros (Marketletter May 5).

The main patent on the antithrombotic drug expires in December 2004, after which it can be copied by generics firms but, until now, no company had applied because the molecule is extremely complex and difficult to produce. This situation may have changed radically, say observers, although Aventis has said that a generic copy of Lovenox is "neither imminent or certain."