FOLIO Ontology

Abbreviated New Drug Application Claim

IRI:
https://folio.openlegalstandard.org/RCsgBzhoO77TRUSo5O757qS
Preferred Label ANDA Claim
Alternative Labels
ANDA Dispute Claim Bioequivalence Application Claim Generic Drug Application Claim Generic Medicine Application Claim

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.

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