The order from the US Court of Appeals for the Federal Circuit does not represent a final decision with respect to the pending appeal or the underlying litigation, however the companies can sell their biosimilar version of sanofi-aventis’ blockbuster blood-thinner, Lovenox, until the court makes its final decision. The companies stated that they planned to launch their generic enoxaparin sodium injection product immediately and product details are already posted on Amphastar’s website.

Amphastar and Watson have a distribution agreement under which Amphastar supplies enoxaparin to Watson, which then markets, sells and distributes the product to retail pharmacies in the US [1].

Lovenox (enoxaparin) is a low molecular weight heparin used in the treatment and prevention of deep vein thrombosis which can lead to blood clots in the lungs. Enoxaparin is also indicated for prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction.

Amphastar received FDA approval of its abbreviated new drug application for enoxaparin back in September 2011, but has been blocked from selling its version due to a patent-infringement suit filed by Momenta [1].

US-based Momenta Pharmaceuticals and Sandoz, Novartis’ generics unit, have been selling their version of enoxaparin since July 2010 [2]. Momenta owns two patents for Lovenox and gets a share of the profit earned from biosimilar enoxaparin sold by partner Sandoz.

For the 12-month period ending 30 July 2011, Lovenox and its biosimilar equivalents had total US sales of approximately US$2.6 billion, according to IMS Health [1].

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References

1.  GaBI Online - Generics and Biosimilars Initiative. Amphastar’s biosimilar enoxaparin approved by FDA – Momenta launches lawsuit [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 3]. Available from: www.gabionline.net/Biosimilars/News/Amphastar-s-biosimilar-enoxaparin-approved-by-FDA-Momenta-launches-lawsuit

2.  GaBI Online - Generics and Biosimilars Initiative. FDA approves first biosimilar enoxaparin sodium [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 3]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-first-biosimilar-enoxaparin-sodium