{"iri":"https://folio.openlegalstandard.org/RCsgBzhoO77TRUSo5O757qS","label":"Abbreviated New Drug Application Claim","sub_class_of":["https://folio.openlegalstandard.org/R9LVBKjvGRuzwgtlhuLST36","https://folio.openlegalstandard.org/RJL4HDUmZp1VEEZ7lCwSSF"],"parent_class_of":[],"is_defined_by":null,"see_also":["https://folio.openlegalstandard.org/D0mnTJCRQ0iGNX03-SnqlQ"],"comment":null,"deprecated":false,"preferred_label":"ANDA Claim","alternative_labels":["ANDA Dispute Claim","Bioequivalence Application Claim","Generic Drug Application Claim","Generic Medicine Application Claim"],"translations":{},"hidden_label":null,"definition":"An Abbreviated New Drug Application (ANDA) Claim arises when there is a dispute or legal challenge related to the submission or approval of an ANDA, which allows for the marketing of a generic drug that demonstrates bioequivalence to an already approved brand-name drug. This claim can involve issues of patent infringement, exclusivity rights, or regulatory compliance.","examples":[],"notes":[],"history_note":null,"editorial_note":null,"in_scheme":null,"identifier":null,"description":null,"source":null,"country":null}