Battle rages over anti-thrombotic medicine

Biosimilars/News | Posted 10/11/2011 post-comment0 Post your comment

Sandoz/Momenta are ahead again in the fight for the lucrative anticoagulants market in the US. According to IMS Health data enoxaparin sodium injection is the best-selling hospital medicine in the US, and has been described as the ‘gold standard’ for anti-thrombotic treatments. Lovenox, sanofi-aventis’ reference product, recorded US sales of US$2.7 billion in 2009 and has been used to treat an estimated 200 million patients worldwide since it was launched.


Sandoz, the generics wing of Novartis, and its partner Momenta Pharmaceuticals won the race to market the first generic version of Lovenox in 2010. In a July press release Mr Jeff George, global head of Sandoz gloated ‘Sandoz is the first company to launch generic enoxaparin sodium in the US, delivering on our strategy of being first-to-market with key products, and underscoring our leadership in differentiated products’. The drug made US$1 billion in the first nine months it was on the US market.

After a protracted battle marked by lawsuits against the agency and conflict of interest allegations, Amphastar Pharmaceuticals got US regulatory approval for its generic blood thinner in September 2011. FDA has been accused of unfairness. Amphastar and partners Watson Pharmaceuticals beat generics giant Teva to second place in the generics market. But within weeks, Sandoz was back with another lawsuit against its rivals, alleging patent infringement.

Being first to market, Momenta and Sandoz can charge higher prices, at least as long as their version was competing only with Sanofi's branded drug. It is a big win for Sandoz. Now, thanks to the ruling, Amphastar and licensee Watson have to fight the patent suit before taking their version to market. Watson says it is considering an appeal. But as the only generics makers with a version of Lovenox to sell, Momenta and Sandoz temporarily hang onto their pricing power – and their 50% market share.

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Source: Sandoz, Watson

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