August 28, 2014 | By Carly Helfand
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.
Thursday, both Mylan ($MYL) and a team comprising Momenta Pharmaceuticals ($MNTA) and Novartis’ ($NVS) Sandoz said the FDA had accepted their ANDAs for three-times-a-week generic Copaxone. Assuming Teva ($TEVA) sues for patent infringement, triggering an automatic 30-month stay, the multiple sclerosis knockoffs could be on the market as early as the first quarter of 2017.
Teva is already wrapped up in patent litigation over the original formulation of Copaxone, which recently saw its patent life truncated 16 months early. That court decision put more than half the company’s profits in jeopardy, and Teva has tried a variety of maneuvers to shield its top seller.
One of those has been changing patients over to the new, more convenient version of the drug, which won FDA approval early this year. So far, the Israeli pharma’s conversion rate has surpassed analysts’ expectations: As of early this month, 51% of patients had made the jump, and Teva now expects that number could rise to 65% by year’s end.
While 2017 is still a long ways off, it’s much sooner than the Petah Tikvah-based drugmaker might have expected competition for its newcomer. Mylan and the Momenta/Sandoz tandem aren’t the only rivals it’s battling, either: As StreetInsider reported earlier this month, the company received notice from India’s Dr. Reddy’s Laboratories that it had submitted its copy for FDA approval, too, and Teva said it intended to file an infringement suit.
In the meantime, Teva is waiting to hear back from the FDA on a citizen petition it filed last month for full-scale, placebo-controlled clinical trials for all Copaxone copies. And in October, the Supreme Court will begin hearing its appeal in the original patent infringement case.
thanks to: FiercePharma