FTC Challenges Over 100 Drug Patents Listed by Pharmaceutical Giants in FDA Orange Book

FTC Accuses Major Pharma Firms, Including AbbVie and AstraZeneca, of Wrongfully Using Orange Book Patent Listings to Block Generics, Drive up Drug Prices

• The Federal Trade Commission (FTC) has challenged more than 100 patents held by brand-name drug manufacturers, including AbbVie and AstraZeneca, arguing they are inaccurately listed in the Food and Drug Administration's Orange Book and blocking competition from generic drugs.
• According to the FTC, these companies' wrongful use of the Orange Book patent listing system artificially inflates drug prices and obstructs fair competition, particularly for medicines and drug products such as inhalers and EpiPens.
• FTC Chair, Lina M. Khan, highlighted the harmful impact of the abuse of the Orange Book, noting it contributes to the continued high cost of medicines such as inhalers due to limited generic competition.
• Beyond AbbVie and AstraZeneca, the commission sent notice letters to Boehringer Ingelheim Pharmaceuticals and seven other manufacturers, questioning the validity and relevancy of some patents listed in the Orange Book.
• The disputed companies have been given a 30-day window to remove their questioned listings or certify that they adhere to the necessary regulatory requirements.

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