Well, that's not going to work. Teva's latest move to try to fend off Copaxone copies, a lawsuit against the FDA, got tossed Wednesday by a federal judge in Washington just 10 days before the med's patent expiration date.
After nearly a year of fighting to protect the patent on its blockbuster leukemia drug Gleevec, Novartis has made peace with Indian drugmaker Sun Pharma, reaching a settlement that will keep Sun's generic version off the U.S. market until February 2016, Reuters reports. Novartis' U.S. patent expires in July 2015.
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.
After a botched launch for obesity drug Qsymia, a bitter proxy war, a mass exodus of its directors and management and a continued sales struggle, the last thing Vivus needs is a generic threat. But thanks to Actavis, that's exactly what it's getting.
Generic drugs underpin the U.S. prescription drug market, making up 80% of the prescriptions written in the country and saving payers billions of dollars annually. But there have always been questions about whether some generics are as effective as the drugs they copy, and the FDA last year kicked off a program to find out.
Teva wants generics makers to hold off on launching their copies of multiple sclerosis drug Copaxone until the Supreme Court hears its appeal in a patent fight over the drug. And unsurprisingly, those generics companies are not that into the idea.
The inability of Ranbaxy Laboratories to get its generic of heart drug Diovan to market for 18 months has been a boon for Novartis. Not so much for consumers.
On Monday, Teva asked Supreme Court Chief Justice John Roberts to consider a plea to block generic competition to Copaxone until SCOTUS has weighed its appeal. And now, he wants to know what generics makers think about it.
Just four months after closing its $1.75 billion acquisition of Agila Specialties, generic drug maker Mylan is eyeing another takeover candidate--Sweden's Meda AB. Pennsylvania-based Mylan is talking with advisers about a takeover bid that could be made at a "significant premium" to Meda's $4.5 billion market value, according to sources quoted by the Financial Times.
The FDA says it wants to level the playing field by having generic drugmakers independently update drug labels when there are known risks to the products. The industry feels as if it is being nudged off a cliff.