Record numbers of generic drugs that could provide much needed relief for Americans with serious medical conditions are failing to come to market because of litigation and the filing of additional patents by brand-name drug manufacturers. The number of generic approvals has set records during each of the past 3 years. In fact, the FDA has approved nearly 2,500 generic versions of 617 brand name drugs since 2016.

Analysts estimate that the price of a branded drug falls by an average of 39% every time four generics for that drug are made available. While there are many factors involved in the delays, the sad reality is that less than half of the generics approved in 2018 have been launched. In the meantime, far too many very sick patients have had to find ways to afford high-priced branded medications.