Patent Certifications and Suitability Petitions
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