MDCO believes that most companies will find it difficult to make bivalirudin in necessary ton quantity. Perhaps the facts that Hatch-Waxman exclusivity expired Nov 2008 and no paragraph IV filings have occurred, imply that generics might have a high manufacturing hurdle.
I do not get your point—why would the lack of a P-IV challenge imply that Angiomax manufacturing is difficult? The simpler explanation is that the Angiomax patent is solid and hence the prospective vendors of generic Angiomax are content to wait until patent expiration in 2010.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”