Competitive generic therapy (CGT) and List Off-patent and Off-exclusivity are two important concepts that are often confused with each other. We will explore the main difference between these two concepts.
Competitive Generic Therapy (CGT): NMT one approved drug in the active section of the Orange Book (RLD/Generic) + no unexpired patents or exclusivities listed in the OB for the relevant RLD at the time the applicant submitted the original ANDA to the Agency or unexpired (if it falls under CGT category)
List Off-patent and Off-exclusivity: No approved ANDA referencing that NDA + no unexpired patents or exclusivities listed in the OB for the relevant RLD at the time the applicant submitted the original ANDA to the Agency.
Further classified as:
1) Prescription drug products for which FDA could immediately accept an ANDA without prior discussion.
2) Prescription drug products for which ANDA development or approval may raise potential legal, regulatory, or scientific issues that should be addressed with the Agency prior to considering submission of an ANDA.
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