Will Lipitor's patent expire without an independent generic version ready to fight for sales? That's the question Mylan has been asking. With Ranbaxy Laboratories lacking FDA approval for its copycat pill--which has first-to-file status--Mylan sued the agency to force the issue. Considering that manufacturing problems are still plaguing two Ranbaxy plants, Mylan claimed that it and other generics firms should be allowed to jump into the market themselves.
But a federal judge has tossed that lawsuit, saying Mylan has no right to sue over pending applications. Instead, the company can wait until the FDA makes its decision on Ranbaxy's approval app (filed through its Matrix Laboratories subsidiary). "Nothing prevents Mylan from seeking judicial recourse if and when FDA renders a final exclusivity decision that is not to Mylan's liking," Judge James Boasberg said in the ruling.
However, as Forbes points out, the whole point of Mylan's suit was to force FDA to make a decision already. If Ranbaxy's 180-day exclusivity claim is no longer valid, then other companies need to know ASAP, the company said in its suit.
The FDA disputes the notion that it has been dragging its feet on Ranbaxy's application. The agency says resolving the exclusivity rights isn't a straightforward matter, the Economic Times reports, and it will decide "as soon as practicable." In the meantime, the only companies sure to be selling Lipitor in November are Pfizer and Watson Laboratories, which has the rights to make an authorized generic version of the drug.