Pfizer to acquire US rights for Synthon's generic Copaxone
US pharma giant Pfizer (NYSE: PFE) has acquired the exclusive commercialization rights in the USA to glatiramer acetate, a potential generic version of the originator Israel-based Teva Pharmaceutical Industries’ (NYSE: TEVA) blockbuster drug Copaxone, for the treatment of relapsing remitting multiple sclerosis (RRMS), from Netherlands-based Synthon.
In November 2011, Synthon filed an Abbreviated New Drug Application with the US Food and Drug Administration for a once daily 20mg/ml formulation of glatiramer acetate. In early 2014, Synthon filed an ANDA for a three times a week 40mg/ml formulation of glatiramer acetate with the FDA. In addition, Synthon believes its glatiramer acetate 40mg/ml filing may be eligible for 180 days of shared marketing exclusivity under the provisions of the Hatch-Waxman Act.
Teva already dealing with competition from Sandoz’ Glatopa
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