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Exclusivity and Generic Drugs

Exclusivity: Period of time when a brand-name drug is protected from generic drug competition

  • New Chemical Entity: 5 yr
  • Orphan Drug: 7 yr
  • New Clinical Investigation: 3 yr
  • Pediatric: 6 mo.  added on to any other exclusivities or patents
  • Antibiotic:  5 yr  added on to any other exclusivities

LEARN

Image credit: FDA

Published by Drug & Device Advisory Group


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