Paragraph I certification
E642123
Paragraph I certification is a type of patent certification in U.S. generic drug applications indicating that no patent information has been filed for the reference listed drug.
All labels observed (1)
| Label | Occurrences |
|---|---|
| Paragraph I certification canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T7110953 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: Paragraph I certification Context triple: [Drug Price Competition and Patent Term Restoration Act of 1984, establishes, Paragraph I certification]
-
A.
Certificates of Suitability (CEP)
Certificates of Suitability (CEP) are official documents that certify a substance’s compliance with European Pharmacopoeia standards, streamlining its use in pharmaceutical products across Europe.
-
B.
Safety Management Certificate
The Safety Management Certificate is an international maritime document issued to a ship to verify that its company and onboard management operate in compliance with the International Safety Management (ISM) Code’s safety and environmental protection standards.
-
C.
CoC Accreditation Program
The CoC Accreditation Program is a quality-improvement and recognition initiative that evaluates and accredits cancer care programs to ensure they meet rigorous standards set by the Commission on Cancer.
-
D.
National Certificate of Educational Achievement
The National Certificate of Educational Achievement (NCEA) is New Zealand’s main secondary school qualification, assessing students through a mix of internal and external standards-based evaluations across multiple levels.
-
E.
CIPM
The CIPM (Comité International des Poids et Mesures) is the international committee responsible for overseeing the global system of units and metrology, operating under the authority of the Metre Convention.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: Paragraph I certification Target entity description: Paragraph I certification is a type of patent certification in U.S. generic drug applications indicating that no patent information has been filed for the reference listed drug.
-
A.
Certificates of Suitability (CEP)
Certificates of Suitability (CEP) are official documents that certify a substance’s compliance with European Pharmacopoeia standards, streamlining its use in pharmaceutical products across Europe.
-
B.
Safety Management Certificate
The Safety Management Certificate is an international maritime document issued to a ship to verify that its company and onboard management operate in compliance with the International Safety Management (ISM) Code’s safety and environmental protection standards.
-
C.
CoC Accreditation Program
The CoC Accreditation Program is a quality-improvement and recognition initiative that evaluates and accredits cancer care programs to ensure they meet rigorous standards set by the Commission on Cancer.
-
D.
National Certificate of Educational Achievement
The National Certificate of Educational Achievement (NCEA) is New Zealand’s main secondary school qualification, assessing students through a mix of internal and external standards-based evaluations across multiple levels.
-
E.
CIPM
The CIPM (Comité International des Poids et Mesures) is the international committee responsible for overseeing the global system of units and metrology, operating under the authority of the Metre Convention.
- F. None of above. chosen
Statements (35)
| Predicate | Object |
|---|---|
| instanceOf |
Hatch-Waxman certification
ⓘ
U.S. generic drug regulatory concept ⓘ patent certification ⓘ |
| abbreviation | Paragraph I ⓘ |
| appliesTo |
Abbreviated New Drug Applications
ⓘ
linked to:
Abbreviated New Drug Application process
generic drug applications ⓘ |
| associatedWith | patent listing requirements in the Orange Book ⓘ |
| basedOn | patent information provided by the NDA holder to FDA ⓘ |
| categoryOf | patent certification options under Hatch-Waxman ⓘ |
| contrastedWith |
Paragraph II certification
ⓘ
Paragraph III certification ⓘ Paragraph IV certification ⓘ |
| definedIn | Hatch-Waxman Act ⓘ |
| documentationForm | certification in the ANDA patent certification section ⓘ |
| governs | applicant’s statement about patent status of the reference listed drug ⓘ |
| hasLegalEffect |
no 30-month stay of FDA approval based on patent litigation
ⓘ
no Paragraph IV patent litigation trigger ⓘ |
| indicates |
no patent information has been filed for the reference listed drug
ⓘ
no patents are listed in the Orange Book for the reference listed drug ⓘ |
| legalJurisdiction |
United States
ⓘ
linked to:
United States of America
|
| notUsedFor | biologics license applications ⓘ |
| partOf |
Abbreviated New Drug Application
ⓘ
linked to:
Abbreviated New Drug Application process
|
| precondition | absence of listed patents for the reference listed drug ⓘ |
| purpose | to inform FDA that no patents are listed for the reference listed drug ⓘ |
| regulatedBy |
U.S. Food and Drug Administration
ⓘ
linked to:
Food and Drug Administration
|
| relatedRegulation | 21 CFR 314.94(a)(12) ⓘ |
| relatedTo | New Drug Application patent listing ⓘ |
| relatesTo |
Orange Book
ⓘ
reference listed drug ⓘ |
| requiredFor | ANDA submission when no patents are listed for the RLD ⓘ |
| requires | review of Orange Book patent listings by the ANDA applicant ⓘ |
| submittedBy | generic drug applicant ⓘ |
| submittedTo |
FDA Office of Generic Drugs
ⓘ
linked to:
Office of Generic Drugs
|
| usedFor | small-molecule drug ANDAs ⓘ |
| usedIn | certification of patent status for generic drug approval ⓘ |
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: Paragraph I certification Description of subject: Paragraph I certification is a type of patent certification in U.S. generic drug applications indicating that no patent information has been filed for the reference listed drug.
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.
Drug Price Competition and Patent Term Restoration Act of 1984
→
establishes
→
Paragraph I certification
ⓘ