Desperate to ward off Copaxone copies, Teva sues FDA

Teva ($TEVA) has already tried unsuccessfully to get the Supreme Court to hold off generics of its multiple sclerosis drug Copaxone while it waits to get its appeal heard. So now, the Israeli company is trying something new: suing the FDA to block copycats' approval.

As Bloomberg reports, the generics giant claims that FDA officials improperly dismissed its calls to subject Copaxone knockoffs to extensive testing before they hit the U.S. market--which could be as soon as May 24, when the top seller is scheduled to lose patent protection.

"There is no question that the agency's actions violate Teva's statutory right to receive a decision on the merits of its petition within the law's statutory" deadline, Teva said in the complaint, as quoted by the news service.

Teva stands to lose a lot if it can't guarantee a delay to potential competition from generics teams led by Mylan ($MYL) and Novartis' ($NVS) Sandoz. Copaxone generates $3.2 billion in U.S. sales each year, making up more than half of Teva's profits. And while the company has shown success at switching patients over to a long-acting formulation approved earlier this year, the new version won't be putting up those kinds of numbers.

Of course, it's still unclear whether generics makers will actually go ahead with their copies later this month. If they do, they risk paying back damages if SCOTUS rules in Teva's favor after hearing its patent-infringement appeal. But even with the reparations, generic launches could cause Teva "irreparable harm," in the form of hundreds of millions of dollars, the company has said.

"Unless this court acts now, the FDA's gamesmanship will preclude Teva from obtaining meaningful judicial review before the FDA allows these putative generic products to overwhelm the market," Teva said in the complaint, as quoted by Bloomberg.

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