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Fight over U.S. orphan drug exclusivity heads to court – again

By Mari Serebrov
Regulatory Editor

Friday, August 11, 2017

Does orphan drug designation for a specified compound bestow exclusivity on each unique formulation of the drug? That's one of the questions a U.S. district court will have to sort out in United Therapeutics Corp. v. the Department of Health and Human Services (HHS).

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