Tertiary Patents on Drugs Approved By the FDA

In a review of over 300 drug-device combinations approved by the FDA from 1986 to 2023, tertiary patents on the delivery device made up more than half of the patents listed for these products.These tertiary patents extended market exclusivity periods by a median of 7.5 years, despite nearly 60% of these patents not mentioning the drug’s active ingredient. Policymakers and regulators should improve oversight of tertiary patents to mitigate such improper Orange Book listings and to ensure timely generic competition.