Does anyone know what happened with the lawsuit against copaxone and their patent?
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Copaxone Patent Lawsuit
Teva Pharmaceuticals claims 2 companies are violating patents on Copaxone. The original suit against Momenta Pharmaceuticals and Sandoz now has expanded to include 10 patents - 3 of which run past the expected generic drug entry of 2014. So when generics will appear is now an open question. Copaxone, approved as an orphan drug, is Teva's flagship product, with sales of over $680 million a year. In addition to being in clinical trials for various combinations, dosage rates, and administration strategies in the mitigation of MS, the drug is now also being studied for Macular Degeneration and Crohn's Disease.
I hope this is of some help.
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I know of at least one US generic pharmaceutical company that is currently running studies on a generic version of Copaxone, plus I'm fairly sure that some of the foreign manufacturers are doing the same. The original trails that were run are mostly likely not submit table to the FDA as they were not run according to FDA regs.
My guess is that these companies will challenge the patent in the US (they almost always do this at the end of a patent with the hope of getting on the market first.) the other thing at could happen is that 1) teva may pay the other generic companies to keep the generic off the market or 2) teva may try to sell an authorized generic of their own. It will be interesting to see what happens.
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