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Synthon’s Glatiramer Acetate Scoops Up Approval

April 19, 2016

Synthon’s generic version of Teva’s Copaxone has gained approval in 29 European countries.

Using an alternative route to marketing authorization, Synthon secured approval last week from all 28 EU member-states and the Netherlands, which is where the company is headquartered.

Pfizer has exclusive rights to commercialize Synthon’s product in the U.S.

The as yet unnamed drug would enter a multibillion dollar market spearheaded by Teva’s Copaxone, which earned $4 billion in revenue in 2015. Copaxone already faces generic competition in the U.S. from Sandoz, which launched Glatopa last June after a federal court invalidated Teva’s patent.