Patent Certifications and Suitability Petitions

To continually improve its pre-ANDA interactions with applicants for generic drugs 

Paragraph IV Patent Certifications

  • Generic applicant provides “paragraph IV certification”  challenging brand product patent listed in FDA’s Orange Book
  • Must notify brand product sponsor/patent holder of ANDA submission and patent challenge
  • If approved, eligible for exclusive right to market generic drug for 180 days

Paragraph IV Certifications List

  • To assist generic drug applicants, FDA publishes list of drug products for which ANDA received containing Paragraph IV patent certification

Suitability Petitions

  • Generic application may petition FDA for ANDA for drug product different from Orange Book listing (e.g. route of administration, dosage form, strength, or active ingredient)


Image credit: FDA

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