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DEPOMED INC. v. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES et al

  1. September 05, 2014

    FDA Must Grant Depomed's Pain Drug Exclusivity, Judge Says

    A Washington, D.C., federal judge on Friday ordered the U.S. Food and Drug Administration to provide Depomed Inc. with seven years of exclusivity for its pain drug Gralise, finding the company doesn't have to prove the drug is clinically superior to a similar drug manufactured by Pfizer Inc.

  2. August 23, 2013

    Depomed Says It Was Cheated Out Of Orphan Drug Exclusivity

    Depomed Inc. urged a Washington federal judge Friday to force the U.S. Food and Drug Administration to give the company seven years of drug exclusivity for its pain drug Gralise, claiming the agency went beyond its authority and added new limitations to its orphan drug program.

  3. September 26, 2012

    FDA Wrongly Denied Orphan Drug Exclusivity, Depomed Claims

    Depomed Inc. on Tuesday sued the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services, alleging they wrongly denied the company market exclusivity for Gralise despite granting the shingles-related pain remedy orphan drug status for treating a rare condition.

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