Competitive Generic Therapy Approvals Listed by FDA

The FDA has provided a list of all products approved under the Competitive Generic Therapy (CGT) designation program under section 506H of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This exclusivity is awarded for products with limited generic competition and provides for a potential 180-day exclusivity marketing period.

On its current list (here), the FDA identified 30 approved products and gives data and dates that may be helpful for the industry.

Information provided in the listings include:

  • Reference Listed Drug (RLD) Name and New Drug Application (NDA) Number
  • ANDA Number
  • ANDA Applicant Name
  • Active Ingredient Name, Dosage Form, Strength
  • Date of Approval
  • Eligible for CGT Exclusivity
  • 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”)
  • Date of First Commercial Marketing of CGT with Exclusivity (“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” the term N/A.}

The information in this list will, according to FDA, be updated every 2 weeks and should provide information to the industry to help them make a decision about seeking a CGT designation for a product, understanding what products have been granted the 180-day exclusivity, those where exclusivity has been forfeited and when, if granted, the period of CGT exclusivity will end.    The document also notes that CGT is also indicated in the Orange Book, much like the 180-day Hatch-Waxman exclusivity awarded to first filers, but, remember, there is only one period of CGT for a CGT product.