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.
Statements (35)
| Predicate | Object |
|---|---|
| instanceOf |
Hatch-Waxman certification
ⓘ
U.S. generic drug regulatory concept ⓘ patent certification ⓘ |
| abbreviation | Paragraph I ⓘ |
| appliesTo |
Abbreviated New Drug Applications
NERFINISHED
ⓘ
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 NERFINISHED ⓘ |
| 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 NERFINISHED ⓘ |
| notUsedFor | biologics license applications ⓘ |
| partOf | Abbreviated New Drug Application NERFINISHED ⓘ |
| 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 NERFINISHED ⓘ |
| relatedRegulation | 21 CFR 314.94(a)(12) ⓘ |
| relatedTo | New Drug Application patent listing ⓘ |
| relatesTo |
Orange Book
NERFINISHED
ⓘ
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 NERFINISHED ⓘ |
| usedFor | small-molecule drug ANDAs ⓘ |
| usedIn | certification of patent status for generic drug approval ⓘ |
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
ⓘ