A podcast/article written by LCDR Rinku Patel, Pharm.D., Patent & Exclusivity Team, Office of Generic Drugs Policy, provides a description of the Competitive Generic Therapies program (which we have described previously here and here). Since we have covered the program in detail and there is an FDA draft Guidance available (here), we will not go into the specifics in this post. But what is new are some numbers on the status and success of the program to date.
The FDA notes in the article:
The success of the program to date is in the numbers. As of March 2019, the FDA has received more than 245 CGT requests, of which over 70% have been granted. FDA has also approved seven ANDAs for generic drugs designated as CGTs that qualified for 180-day CGT exclusivity.
Kudos to the FDA on a program that is working well to stimulate generic competition for products with, essentially, no current competition!