Characteristics and Price Increases Among Sole-Source, Off-Patent Drugs in the United States, 2008 to 2018

A basic tenet of the biotechnology 'social contract' is that once a drug has gone off patent-protection, it should theoretically become inexpensive. It’s like paying off a 20 year mortgage on your home, and knowing that you now own it and can pass it on to your children and their children.

But drug manufacturers can sometimes exploit regulatory policy (or lack thereof) and take advantage in certain markets to raise prices egregiously on old, off-patent products. This latest article via @JAMANetworkOpen examines the characteristics and price increases among 300 sole-source, off-patent drugs in the United States over the course of a decade (2008-2018). 

Approximately one-third of products (95 of 300) had prices that increased by 25% or more during any calendar year, and approximately one-quarter of drug products (66 of 300) had prices that increased by 50% or more during any calendar year.

This is the first study to-date to comprehensively analyze the drug attributes and prevalence of price increases affecting sole-source, off-patent, and off-exclusivity drugs in the U.S.

Two of the current 'Top-20' most expensive out-patient prescription drugs in America are off-patent.