The History Behind The Drug-Device Combos Targeted By FTC

Of the 16 products whose Orange Book patent listings have been challenged by the FTC, six have no generic competitors and two faced first generic launches this year. A review of their patent and pricing battles shows the difficulties in developing generics for these complex drugs.

Inhalers whose patents were deemed improperly listed in the Orange Book by the Federal Trade Commission have retained market dominance with their device components. • Source: Shutterstock

The US Federal Trade Commission’s letters to drug companies asserting they had improperly listed patents in the Food and Drug Administration’s Orange Book surprised many in the pharma space as the patents all pertain to drug-device combination products that have been on the market a long time. But a look at their history reveals how many of these complex products have avoided generic competition and retained blockbuster status.

Of the 16 products cited by the FTC, six have no generic competition and two faced generic competitors in the...