Fourth Time’s The Charm? Teva Cites Colloids in Latest Attempt to Convince FDA to Require Clinical Trials for Generic Copaxone

FDA has rejected three previous citizen petitions from Teva seeking to impose barriers on future generic filers for the MS drug.

With less than two years to go on the patents on its multiple sclerosis drug Copaxone (glatiramer acetate), Teva Pharmaceuticals USA Inc. is making a fourth attempt to petition FDA to require potential generic competitors to conduct full-blown clinical trials, following the agency’s rejection of three previous citizen petitions from the company.

Seven patents on the drug expire simultaneously May 24, 2014, and exclusivity ended Feb. 27, but Teva’s multiple attempts to...

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