I'm sure this will become business as usual as each new blockbuster hits its patent expiration date and generic competitors vie to be first to market and gain 180 day exclusivity in the process.
In this case, Mylan is suing to force the FDA to block Ranbaxy's application to sell generic Lipitor first and to deny Ranbaxy 180 day exclusivity in the process. Mylan says Ranbaxy should be denied as the FDA accused it of submitting false data in previous drug applications to the agency in 2009.
Ranbaxy wants to go to market in November. Mylan is also seeking approval of its generic version of Lipitor and wants to go to market in June when certain Lipitor patents expire on June 28th. Mylan has asked the court to force the FDA's hand in making a decision - NOW.
The FDA says it is still considering both applications and won't make any exclusivity decisions until it makes (or gets ready to make) and approval -- and that may or may not come prior to June 28th. Mylan says this uncertainty around Ranbaxy will cost it market share and is revising its share estimates down from 40% to 20%.
Meanwhile, Watson Pharmaceuticals in a deal with Pfizer will be launching the only "authorized generic" form of Lipitor (what marketing!) and is also targetting a November launch. I think we can all look forward to more of the same with other blockbuster "generics" in the future. See the WSJ.
Posted by Bruce Lehr April 7th 2011.