Pfizer Snaps Up Potential Copaxone Generic

August 10, 2015

Pfizer has acquired exclusive rights to market potential generic versions of Teva’s multiple sclerosis drug Copaxone, under an agreement with Synthon.

The deal, gives Pfizer commercialization rights in the U.S. for two formulations of glatiramer acetate, while Synthon will be responsible for clinical development, manufacture and supply of the drug.

The FDA is reviewing ANDAs for both formulations to treat relapsing remitting multiple sclerosis — a once daily formulation filed in November 2011 and a thrice weekly formulation filed in early 2014. The latter may be eligible for 180 days of shared marketing exclusivity under Hatch-Waxman Act provisions, Synthon says.

Financial terms of the agreement were not disclosed.

In June, Sandoz launched Glatopa, the first substitutable generic of Copaxone, following a federal appeals court ruling that invalidated Teva’s patent. — Jonathon Shacat