Teva files suit against US FDA over generic Copaxone

Israel-based Teva Pharmaceutical Industries (NYSE: TEVA) has complained to the US Food and Drug Administration that generic versions of its blockbuster drug Copaxone (glatiramer acetate) should have clinical trials before they are approved.

This appeal was rejected by the FDA on May 2 and Teva has now filed a law suit against the agency in the US federal court in Washington. The company’s complaint said: “There is no question that the agency’s actions violate Teva’s statutory right to receive a decision on the merits of its petition within the law’s statutory deadline.”

As this stand, Copaxone, for multiple sclerosis, is set to lose its US patent on May 24. Teva previously said that group net sales would amount to $19.8 billion to $20.8 billion in 2014, provided Copaxone keeps its exclusivity. If generics appear as soon as Copaxone’s patent this month, then Teva expects group sales of $19.3 billion to $20.3 billion. USA-based Mylan Laboratories (Nasdaq: MYL) has already said that it hopes to release a generic version of the drug in the USA this year.