ANDA Claim

Abbreviated New Drug Application Claim - 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.

Class Information

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
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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.
Examples
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Class Relationships

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Additional Information

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Notes
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Deprecated
False

Metadata

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