FDA Releases an Updated List of Approved Drugs with No Generics
(Thursday, June 16, 2022)
Since the infamous case of Daraprim price gouging in 2015 where a drug company bought the rights to a drug with no generics and raised the price by 5000% overnight due to its monopoly, FDA has been publishing a list of approved drugs with no patent protection and no generic versions to encourage the industry to create generic versions for those drugs. And the list has been successful to some extent. Several of the drugs on the FDA’s list have since had generic versions created, and several drugs have had monographs written for them, making it easier to reproduce. FDA kept its promise to refresh and improve this list every six months. This week FDA published the June 2022 “List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic” (OPOE list). Since last year, FDA split the list into two, one for the drugs approved under NDA applications, and one for the OTC drugs. In the latest iteration, FDA also included drugs for which the next version was approved as its own NDA and not an ANDA. This is a must-see list not only for those interested in developing new generics for off-patent drugs but also for 505(b)(2) developers. The drugs for which significant demands exist usually have generics competing for the market share immediately upon patent expiration. That is what happened in the last several years; all the drugs with significant market but no generics, got generic versions thanks to the FDA’s list. The irony is that most of the drugs remaining on the list are those for which there is little market demand for various reasons. So, the practical impact of this list seems to be waning with time.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC