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All Orphans Must Get 10-Year Exclusivity, Says Top EU Court

This article was originally published in SRA

Executive Summary

In a judgment that upholds a central tenet of Europe's Orphan Drug Regulation, the Court of Justice of the EU has ruled that all orphan medicines are entitled to a full 10-year period of market exclusivity, even if they have been approved as "similar" to an existing orphan drug1.

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