What animal drug products are eligible to be copied as generics?
All animal drugs that were approved for safety and effectiveness on November 16, 1988, or have been approved since that date, and are not protected by patent or exclusivity are eligible for copying under the provisions of the GADPTRA, unless the animal drug has been subsequently withdrawn from the market for safety or effectiveness reasons, or unless it is the subject of a Notice of Hearing that has been published in the FEDERAL REGISTER. To meet requirements of the GADPTRA, the Center for Veterinary Medicine has arranged for the publication of a list of animal drug products that are eligible to be copied as generics (Green Book). • What is exclusivity? The GADPTRA provides for a period of 3 years of marketing exclusivity for a new use of an animal drug (a use that required reports of new clinical or field investigations for its approval), during which time no abbreviated application for a generic copy may be approved for the new use. The law provides for a period of 5 years of marketi
