The Office of Generic Drugs is providing a public list of all approved abbreviated new drug application (ANDAs) for drug products that received a Competitive Generic Therapy (CGT) designation under section 506H of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and is also noting which ANDAs on this list cover drug products that were also eligible for CGT exclusivity under section 505(j)(5)(B)(v) of the FD&C Act.  This list will be updated on a bi-weekly basis with new ANDA approvals where at least one of the drug products, i.e., one of the strengths, in the approved application received a CGT designation.

The Agency is including the following information for individual drug products on the CGT Approvals List:

• Reference Listed Drug (RLD) Name and New Drug Application (NDA) Number
  This column reflects the proprietary name, if any, of the RLD and its NDA number.
• ANDA Number
• ANDA Applicant
• Active Ingredient Name, Dosage Form, Strength
  This column reflects the established (nonproprietary) name of the active ingredient(s) in the drug product, as well as the product’s dosage form and strength(s).
• Date of Approval
  This column indicates the date on which an ANDA for a CGT-designated drug product(s) received final approval.
• Eligible for CGT Exclusivity
  In this column, drug products that, at the time of approval, were eligible for CGT exclusivity will be indicated with a “Yes,” while drug products that were not eligible for CGT exclusivity at the time of approval will be indicated with a “No.”  Certain products in ANDAs designated as CGTs can qualify for CGT exclusivity if the applicant is a “first approved applicant” as defined in section 505(j)(5)(B)(v) of the FD&C Act.  There is only one exclusivity period available for each CGT, and receiving a CGT designation does not ensure that a drug product will be eligible for CGT exclusivity.  For example, a drug product in an ANDA that receives a CGT designation will not be eligible for CGT exclusivity if there were unexpired patents or exclusivities listed in the Orange Book at the time of the original submission of the ANDA for the CGT-designated drug product.
• CGT Exclusivity Forfeiture
  This column indicates whether or not a drug product that was eligible for CGT exclusivity upon approval forfeited eligibility because it was not commercially marketed within 75 days after the date of approval of the ANDA (see section 505(j)(5)(D)(iv) of the FD&C Act).  A forfeiture event is indicated with “Yes.”  Non-forfeiture is indicated with “No.”  If the forfeiture determination has not yet been made, the column will be blank, and if the CGT was not eligible for exclusivity upon approval, the column will reflect “N/A.”
• Date of First Commercial Marketing of CGT with Exclusivity
  This column reflects the date of first commercial marketing of a CGT by a first approved applicant of a drug product that was eligible for CGT exclusivity and did not forfeit its eligibility.  The 180-day CGT exclusivity period described under section 505(j)(5)(B)(v) of the FD&C Act is triggered by the first commercial marketing of the competitive generic therapy (including the commercial marketing of the listed drug) by any first approved applicant.  This 180-day CGT exclusivity period, once triggered, blocks the approval of an ANDA for a drug that is the same as the CGT.  If the CGT was not granted exclusivity, or the exclusivity was forfeited, the column will reflect “N/A.”

FDA intends that the information on the list will provide transparency to prospective applicants and other interested parties with respect to the history of CGT designations for approved ANDAs and whether individual products qualified for CGT exclusivity.  FDA believes that this information will be useful to help demonstrate the impact of the CGT provisions of the FD&C Act on encouraging development of drug products for which there was inadequate generic competition, and will also aid generic applicants by identifying drug products for which CGT exclusivity has already been granted (as noted above, there is only one exclusivity period for each CGT).  By providing the commercial marketing start date for CGT exclusivity periods, this list will also provide useful information to applicants whose ANDAs have been blocked from final approval by CGT exclusivity regarding when the exclusivity period will expire.  To note, FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book) also posts a Competitive Generic Therapy (CGT) code in the “Exclusivity Data” section of the Orange Book for the approved drug products eligible for 180-day CGT exclusivity upon any first approved applicant’s commercial marketing, indicating the date the 180-day CGT exclusivity will expire.

Competitive Generic Therapy Approvals