US Orphan Drug Exclusivity Criteria Clarified in Depomed Court Decision

Posted 04 December 2014 By Alan Minsk, JD

placeholder+image Key points and observations about a recent federal court decision on orphan drug exclusivity as outlined in the case of Depomed v. US. The central issue concerned what conditions a drug must satisfy to qualify for marketing exclusivity.

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Categories: Generic drugs, Orphan products, Features, US

Tags: Depomed v US, orphan drugs, Neurontin, Gralise, post-herpetic neuralgia, exclusivity, clinical superiority

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