|Image courtesy of Kaiser Permanente|
Branded drug: Lovenox
U.S. sales: $1.28 billion
This copycat of the Sanofi ($SNY) anticoagulant Lovenox came into the market in a big way two years ago. The first-quarter sales of the product were $292 million, setting it up to be the blockbuster that it has become. It was developed by Novartis' ($NVS) generics unit Sandoz, along with Momenta Pharmaceuticals. It caught Sanofi somewhat by surprise. The French drugmaker had not expected the FDA to approve a generic so soon, particularly of a complex biologic drug. Enoxaparin isn't a full-blown biotech drug, but it is more complicated to make than your small-molecule meds, and its approval was seen as something of an indicator about the FDA's future review process for biosimilars. Key to the generic enoxaparin's success is that the FDA made it substitutable for the branded version.
The injectable drug from Novartis and Momenta only recently met other generic competition. Amphastar and distribution partner Watson Pharmaceuticals ($WPI) pushed their way in with a copycat earlier this year and have been selling it even as they fight a court battle with Momenta over the legitimacy of their product. Sanofi had its own authorized generic but spiked it this year, apparently believing that it can do better with just the branded med. Last year, before the Amphastar version was available, Sanofi saw its U.S. sales of Lovenox drop 56% to €633 million ($810 million) from €1.4 billion ($1.8 billion) in 2010.
Watson, Amphastar launch Lovenox copy on court ruling
Sanofi spikes authorized Lovenox generic
Amphastar's Lovenox copy likely to shake market