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In a recent meeting, the Federal Trade Commission (FTC) challenged more than 100 patents held by manufacturers of brand-name asthma inhalers, epinephrine autoinjectors, and other drug products as improperly or inaccurately listed in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book.”


  1. What were the reasons for the challenge?
  2. What is the Orange Book?
  3. What does listing in the Orange Book signify?
  4. How many companies were sent FTC letters?
  5. Who were these companies?
  6. How does this issue affect accountants for the challenged companies?


FTC Staff. (2023). FTC Challenges More Than 100 Patents as Improperly Listed in the FDA’s Orange Book, Press Release, Nov. 7 (Retrievable online at