Statements (17)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:law
|
| gptkbp:alternativeTo |
Paragraph I, II, III certifications
|
| gptkbp:cause |
180-day exclusivity
|
| gptkbp:enables |
ANDA approval
|
| gptkbp:filingDate |
gptkb:FDA
generic drug manufacturer |
| https://www.w3.org/2000/01/rdf-schema#label |
Paragraph IV certification
|
| gptkbp:involves |
NDA holder
patent holder |
| gptkbp:legalBasis |
21 U.S.C. § 355(j)(2)(A)(vii)(IV)
|
| gptkbp:purpose |
challenge brand-name drug patent
|
| gptkbp:relatedTo |
gptkb:Hatch-Waxman_Act
generic drug approval |
| gptkbp:requires |
gptkb:Abbreviated_New_Drug_Application
|
| gptkbp:triggeredBy |
patent litigation
|
| gptkbp:bfsParent |
gptkb:Hatch-Waxman_Amendments
|
| gptkbp:bfsLayer |
8
|