Generics makers have been champing at the bit to get a copy out of Teva's Copaxone, the best-selling multiple sclerosis med that generated $4.2 billion in revenue last year. But according to Momenta CEO Craig Wheeler, his company's version--a joint effort with partner Sandoz, Novartis' generics unit--may be the only knockoff around for a while.
The cost of multiple sclerosis drugs has skyrocketed over the past 20 years, and it's not just new drugs driving that increase. Not one MS drug has a list price of less than $50,000 per year in the U.S., and some treatments cost 7 times more now than they did in 1995, a new study found.
It's been a long battle since a court upturned Teva's Copaxone patent in July 2013, but a Supreme Court fight, several petitions and a regulatory journey later, Copaxone generics are here.
It's not just that Teva doesn't want the FDA to approve generics of its MS star, Copaxone. It really, really, really does not want the FDA to approve them, and it's filed yet another citizen's petition to the agency with a crop of reasons why it shouldn't.
After scouring Teva Pharmaceutical for potential marketing and kickback violations for more than a year, the U.S. Justice Department decided not to join up with whistleblowers suing the company. But the two former sales reps are persisting with civil claims that the Israel-based drugmaker used kickbacks, disguised as speaking fees, to persuade doctors to boost prescriptions of its multiple sclerosis drug Copaxone and Parkinson's med Azilect.
Teva finally has the Supreme Court Copaxone patent battle victory it's been waiting for--but that doesn't mean its legal journey is over.
Teva Pharmaceuticals has cut $650 million in costs this year but needs to more than double that over the next two as it faces generic competition to its workhorse multiple sclerosis drug Copaxone. A big part of that will be to continue revamping its production network, CEO Erez Vigodman says.
Don't be surprised if Teva's revenue numbers don't meet analysts' expectations in 2015. According to the company's forecasts, generic competition to top-seller Copaxone and foreign currency hits will take their toll on Teva's top line next year.
Teva has already surprised analysts with the success it's had converting patients from multiple sclerosis star Copaxone to a new, long-acting version. And now, the company is preparing to take the med to Europe.
Sales of Teva's multiple sclerosis drug, Copaxone, are still growing--at least for now. The Israeli company's top-seller, whose patent is currently the subject of a Supreme Court appeal, ticked up 5% to reach $1.1 billion in Q3 sales.