Sandoz Inc. v. Cochran

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA SANDOZ INC., Plaintiff, v. No. 21-cv-600 (DLF) XAVIER BECERRA, Secretary, United States Department of Health and Human Services, 1 et al., Defendants. MEMORANDUM OPINION Sandoz Inc. challenges a decision of the Food and Drug Administration (FDA) that granted four years of market exclusivity to the sponsor of a new drug, Aubagio. See Compl. ¶ 1, Dkt. 1. Sandoz argues that the sponsor was not entitled to exclusivity because the FDA had previously approved the use of Aubagio’s active ingredient in another drug, Arava. See id. ¶¶ 66–85.…