Amphastar Pharmaceuticals finally has the FDA's blessing. After a protracted battle marked by lawsuits against the agency and conflicts of interest allegations, the company got U.S. regulatory approval for its copycat version of Sanofi's ($SNY) Lovenox blood thinner. It will be the second to market with a Lovenox copy after Momenta Pharmaceuticals ($MNTA)--which won FDA approval last year--and beat out generics giant Teva Pharmaceutical Industries ($TEVA).
Momenta markets its version in concert with Novartis' ($NVS) generics unit Sandoz, and its ability to get the first FDA nod was seen as a big coup--albeit an unfair coup, according to some, as Pharmalot notes. Lovenox is a complex injectable drug, so it's more difficult to copy than the average pill. Plus, being first to market, Momenta and Sandoz could charge higher prices, at least as long as their version was competing only with Sanofi's branded drug. During a second-quarter earnings call, Momenta said its version of the drug had brought in more than $1 billion since last fall's launch, the Wall Street Journal points out.
Amphastar's FDA approval is likely to change that. Teaming up with Watson Pharmaceuticals ($WPI) to market the drug in the U.S., Amphastar will be jockeying for market share, which generally means price competition. Momenta's shares dropped by more than 30% on the news.
Meanwhile, Sanofi's branded drug has taken a major hit. Lovenox's global sales were $4.28 billion in 2010, but dropped to $1.5 billion during the first half of this year. With additional generic competition, that figure will no doubt continue to drop.