Patents are granted by the United States Patent and Trademark Office (USPTO) anywhere along the development lifeline of a drug and can encompass a wide range of claims. Drugs may be issued multiple patents. FDA is required by law to list in the Orange Book the patent number and expiration date of each patent that claims the drug or method of using the drug. FDA defines drug as drug substance (active ingredient) or drug product (formulation and composition).
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and may run concurrently with a patent but need not do so. Exclusivity is granted to a new drug applicant if statutory requirements are met. See 21 Code of Federal Regulations (C.F.R.) 314.108. Exclusivity was designed to promote a balance between new drug innovation and generic drug competition.
The length of exclusivity depends on the type of exclusivity granted:
Orphan Drug (ODE) - 7 years
New Chemical (NCE)- 5 years
"Other" Exclusivity - 3 years for a "change" if criteria are met
Pediatric Exclusivity (PED) - 6 months added to existing Patents/Exclusivity
Patent Challenge – (PC) – 180 days (this exclusivity is for Abbreviated New Drug Applications (ANDAs only)