# Abbreviated New Drug Application Claim

**IRI:** https://folio.openlegalstandard.org/RCsgBzhoO77TRUSo5O757qS

## Labels

**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.

## Sub Class Of

- https://folio.openlegalstandard.org/R9LVBKjvGRuzwgtlhuLST36
- https://folio.openlegalstandard.org/RJL4HDUmZp1VEEZ7lCwSSF

## See Also

- https://folio.openlegalstandard.org/D0mnTJCRQ0iGNX03-SnqlQ

**Deprecated:** False