The Office of Generic Drugs updated its list of the Competitive Generic Therapy (CGT) designation products that have been approved to date (here).  There have been 312 products granted this designation since the start of the program, with the first application approved to gain CGT 180-day exclusivity under 506H of the Federal Food, Drug, and Cosmetic Act on August 8, 2018.

There are a lot of statistics provided in the list including:

  • RLD name and NDA number
  • ANDA number
  • Name of the ANDA applicant
  • Active ingredient name, dosage form, and strength
  • Date of ANDA approval
  • Whether the ANDA is eligible for CGT exclusivity
  • Whether CGT exclusivity was forfeited
  • Date of first commercial marketing of CGT with exclusivity (remember, a product subject to a GCT designation must be brought to market within seventy-five days after approval to retain eligibility for the 180-day exclusivity reward)

We looked at the number of products that have been approved with a GCT designation in 2024 thus far and found some interesting facts.  Forty-five ANDAs were approved with the CGT designation through July 23, 2024.  Of those forty-five, only eight received the 180-day exclusivity (compared to thirty-one receiving CGT exclusivity in 2023), and eight remain eligible for the exclusivity but have not yet been launched within the 75-day window after approval.

Being that we’re seven months into the calendar year and only eight products have received CGT exclusivity, what could be some of the reasons for the apparent decrease in exclusivity awards?  First (in my way of thinking) is the fact that “about 30% of ANDA approvals are not launched in the first year after approval” (see prior post here), thus making them ineligible for the GCT exclusivity.  Problems in scheduling post-approval validation studies or supply-chain issues could also account for why many firms can’t launch within seventy-five days of approval and never get the advantage of exclusivity.  It could also be that, since 2018, when CGT was statutorily approved, firms may have learned that many of the products that have had little or no competition did not have any because the market was no longer interested in the drug; thus, firms became more selective in chasing GCT designations.  In addition, remember that only the first product approved that has a CGT designation may be awarded the 180-exclusivity; thus, there may be multiple ANDAs designated for the same product but, like a horse race, only the first to cross the finish line is eligible.  It is also possible that the number of commercially viable targets for CGT have decreased.  Whatever the reason, it appears that, at least this calendar year, the success rate for GCT exclusivity has fallen by the wayside.  Maybe we’ll take another look at this list at the end of the calendar year to see whether there are any changes in our thinking.