Teva's been waiting a long time to get its Copaxone patent appeal before the Supreme Court. And now that the court has heard oral arguments, it seems to be divided on the issue.
After trying nearly everything in its power to protect lead product Copaxone from early generic competition, Teva just received some news it least wants to hear: Copycats are going after its new, long-acting version of the drug, too.
Teva's long-acting version of multiple sclerosis treatment Copaxone has surpassed most analysts' expectations. But as competition to the original looms, will Teva consider discontinuing off-patent Copaxone to push patients toward the protected version in a quest to maintain market share? The short answer: Yes, but not just yet.
Teva just won't give up on delaying generic Copaxone. Its latest tactic: filing a citizen petition with the FDA to once again push for full-scale, placebo-controlled clinical trials for all copies of its multiple sclerosis med.
Teva Pharmaceutical Industries CEO Erez Vigodman has been a busy man. So busy, in fact, it seems the company's press releases barely keep up with him. Today's announcement: Vigodman has overhauled Teva's management structure, winnowing out 6 executive jobs and creating two worldwide divisions. And he recruited a pharma-industry vet to take the helm of one of them.
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.
Teva has achieved the fastest market adoption of any MS therapy in the United States. That's no accident, John Hassler, VP of marketing for Teva's central nervous system division, told FiercePharmaMarketing. It's the result of more than 18 years of building brand loyalty--a job for which the company was recognized last week.
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.
Last week, generics makers asked the Supreme Court to let them launch their copies of Teva's Copaxone while it hears the Israeli company's appeal over the drug's patents. Now, they'll likely get that chance. Chief Justice John Roberts rejected Teva's bid to block competition until the court clash wraps, meaning generics could hit as soon as next month.
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.