Tertiary Patents on Drugs Approved by the FDA

How have medical device patents contributed to periods of market exclusivity on drug-device combinations?In this cohort study of 331 drug-device combinations approved by the Food and Drug Administration (FDA) from 1986 to 2023, 1751 of 3241 individual patent listings were on the delivery devices of these products. Medical device patents extended periods of protection for 180 products (54.4%) by a median (IQR) of 7.5 (2.8-13.9) years, with most device patents failing to mention the active pharmaceutical ingredients in their claims.Patenting strategies on drug-device combinations may impede generic entry and keep prices high for patients and payers.

Corresponding Author: William B. Feldman, MD, DPhil, MPH, Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of California, Los Angeles, 200 Medical Plaza, Suite 365, Los Angeles, CA 90095 (wfeldman@mednet.ucla.edu).

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