FDA OKs Generic Copaxone

Sandoz will soon have its own corner of the multiple sclerosis market, following FDA approval of its Glatopa generic version of Copaxone.

Glatopa (glatiramer acetate) 20 mg is the first substitutable generic to Teva’s blockbuster multiple sclerosis drug, say Sandoz and Momenta Pharmaceuticals, the companies that developed the drug.

The Israeli brandmaker fought long and hard to put off this day. Teva’s ’808 patent on the 20 mg formulation of the drug is still being contested in the courts, but is set to expire on Sept. 1.

This means that Glatopa may have to wait until then to launch, says Momenta CFO Rick Shea. While he declined to speculate on how much market share the generic might spirit away from Teva, the approval is sure to be a major blow. Copaxone sales brought in about $1.1 billion for the brandmaker in the last quarter of 2014.

Exclusivity on a 40-mg formulation of the drug doesn’t run out until 2030, and Teva has been pushing hard to get patients to switch to the higher-dose formulation. As of February, about half of Copaxone patients have made the switch. — Lena Freund