Natco Pharma, the Hyderabad based generic drug maker, is all set to take on the global pharma major Teva in a case related to generic Copaxone indicated for multiple sclerosis.
Natco with Mylan has filed an abbreviated new drug application with the US Food and Drug Administration (FDA) for marketing Copaxone clone in the US.
Meanwhile, Teva has filed a citizen’s petition (CP) alleging that generic drug makers can’t show their drug is a precise copy of Copaxone — a fact that should preclude market approval.
A CP normally delays the launch plans of generic companies as the FDA tries to work on the objections raised by the company, which is already marketing its product. In fact, Teva had filed one such CP in 2008 but failed in convincing the authorities.
Natco feels the generic would offer a significant upside once its ANDA is approved by the regulator.
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