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Non-Patent Exclusivity - Orange Book Blog
www.orangebookblog.comFive Types of Non-Patent Exclusivity • New Chemical Entity (“NCE”) Exclusivity – 5 yrs • New Clinical Study Exclusivity – 3 yrs • Orphan Drug Exclusivity – 7 yrs • Pediatric Exclusivity – 6 mos • Generic Drug Exclusivity – 180 days