The first approved generic of the multiple sclerosis drug Copaxone launched this week after a federal appeals court Thursday upheld a ruling that drug maker Teva Pharmaceuticals' patent on its best-selling drug was invalid.
In a 2-1 decision, the U.S. Court of Appeals for the Federal Circuit, ruled against the Israeli-based pharmaceutical firm. The drug maker fought for years to delay generic competitors to its drug, which generated $4.8 billion sales worldwide in 2013.
The new generic drug Glatopa, is being developed in the U.S. as part of a collaboration between Novartis subsidiary Sandoz and Massachusetts-based drug maker, Momenta Pharmaceuticals.
Its estimated starting price is around $173 per individual syringe, according to a Sandoz spokeswoman. If taken once a day, the cost could total more than $5,000 a month. Glatopa's initial price does not seem to offer a significant discount to the cost of Copaxone, which has an average price of more than $6,000 for a month's supply.
In April, Sandoz received approval from the Food and Drug Administration to market Glatopa.
Copaxone has been one of the leading medications for the treatment of MS since receiving FDA approval in 1996. Teva received FDA approval last year for a new concentrated version of Copaxone, called Copaxone 40mg/mL, which is administered three times a week as opposed to the original 20-milligram version taken once a day.
Rising drug costs have been a concern among patients, insurers and pharmacy benefit managers in recent years.
On Friday, Teva announced it had completed purchase of a 4.6% interest in generic drug company Mylan, which itself is in the process of developing a generic version of Teva's 40mg version of Copaxone.
In response to the court's ruling, Mylan CEO Heather Bresch said the company remained "very confident in our application for our generic version of Copaxone."
"Further, we believe this ruling underscores concerns with Teva's ongoing financial prospects, as Teva's Copaxone franchise has historically been its largest and most significant revenue driver," she added.
