Identification
- Label (rdfs)
- Abbreviated New Drug Application Claim
- Preferred Label
- ANDA Claim
- Alternative Labels
- ANDA Dispute Claim, Bioequivalence Application Claim, Generic Drug Application Claim, Generic Medicine Application Claim
- Identifier
- N/A
Definition and Examples
- 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.