Just how uncertain is the potential generic competition for Pfizer's megablockbuster Lipitor? Fortune says the prospects are so murky, Wall Street analysts keep complicated flow charts of the many possible scenarios. It all hinges on the actions of the FDA--and its negotiations with Ranbaxy Laboratories, which was first to file for a generic Lipitor approval--but also has serious unresolved regulatory problems.
Fortune's sources say Ranbaxy and the agency are working on a criminal and civil settlement that could involve fines and other payments of more than $1 billion. That would be an enormous deal, settling a host of manufacturing and quality-control violations. It would rival, in fact, several government settlements with Big Pharma. And with $1.9 billion in 2010 revenues, Ranbaxy is far from a Big Pharma company.
If that's the amount Ranbaxy ends up agreeing to pay, then it will need its Lipitor exclusivity more than ever. As Fortune points out, analysts expect Ranbaxy to rake in $600 million in profits--not sales, profits--in its six months of exclusive generic Lipitor sales. "For Ranbaxy, this is the fight of [its life]," one pharma lawyer told the magazine. "This is the biggest generic opportunity in history. None of us know where this is going to come out.
- read the Fortune story