Teva Downplays Generic Copaxone as Momenta Gains Patent

Momenta Pharmaceuticals has been granted a patent for a method of developing its generic version of Copaxone, but Teva Pharmaceutical Industries maintains that its blockbuster multiple sclerosis drug is not facing imminent competition. The ’187 patent, which was issued by the PTO Feb. 8, is entitled “Analysis of Amino Acid Copolymer Compositions” and includes claims to methods of preparing glatiramer acetate, the active ingredient in Copaxone, Momenta says. Teva has insisted that any generic versions of Copaxone should require clinical trials before being approved and the company has filed multiple citizen petitions with the FDA to reinforce that point.
Washington Drug Letter