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news.Teva Pharmaceutical Industries has commented on Momenta Pharmaceuticals and Sandoz's announcement regarding the filing of an abbreviated new drug application containing a Paragraph IV certification for Copaxone, a multiple sclerosis therapy.
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Teva expects to receive Momenta and Sandoz’s Paragraph IV certification notice referring to Teva’s US patents, which cover the chemical composition of Copaxone, pharmaceutical compositions containing it, and methods of using it.
Teva intends to file a lawsuit for patent infringement against Momenta and Sandoz within the 45-day period provided under the Hatch-Waxman legislation. The lawsuit will trigger a stay of the FDA approval of the Momenta and Sandoz abbreviated new drug application (ANDA) until the earlier of the expiration of a period of 30 months or a district court decision in its favor.
Momenta and Sandoz cannot launch a generic version of Copaxone before receiving final approval of the ANDA from the FDA. Copaxone is a glatiramoid, a complex mixture of the acetate salts of synthetic polypeptides, non-uniform with respect to molecular weight and sequence.