Generic Drugs: Stakeholder Views on Improving FDA’s Information on Patents

The Orange Book Transparency Act of 2020 includes a provision for GAO to review Orange Book patent listings for drug-device combination products, including the implications of these listings for generic products.

In this report, GAO describes stakeholder views on how Orange Book patent listings affect the entry of generic drug-device combination products into the market, FDA’s role in overseeing the Orange Book, and proposals for improving Orange Book patent listings.