Module 1administrativenda
1.2.6 — Patent Information
Patent information for Orange Book listing
Requirements by Phase
Phase 1
N/A
Phase 2
N/A
Phase 3
N/A
NDA
required
Patent information for Orange Book listing
Requirements by Phase
NDA: required
Content Requirements
- Patent number(s) covering the drug substance, drug product, or method of use
- Patent expiration date(s)
- Patent claims relevant to the drug product
- Information for Orange Book listing
Expected Deliverables
- Patent certification form
- Patent information listing
ICH Guidelines: 21 CFR 314.53
Source: 21 CFR 314.53
References
Related Sections
Up to1.2 — Cover Letter1.2.1 — Application Form (FDA Form 356h)
FDA Form 356h application form for NDA/BLA submissions
1.2.2 — Form FDA 1571 (IND)
FDA Form 1571 IND application cover form
1.2.3 — Form FDA 1572 (Statement of Investigator)
FDA Form 1572 signed statement from each participating investigator
1.2.4 — Form FDA 3674 (ClinicalTrials.gov)
FDA Form 3674 certification of compliance with ClinicalTrials.gov requirements
1.2.5 — Prescribing Information / Labeling
Prescribing information and approved labeling for NDA
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