March-in authority allows the federal government to grant licenses on privately owned patents for inventions developed with federal funding provided certain statutory requirements are met. It was designed to ensure that the benefits of the American taxpayers’ investment in research and development are reasonably accessible to the public. To date, no agency has initiated march-in proceedings, but march-in may help reduce the prices of certain drugs. This issue brief identifies 39 unique small molecule drugs, comprised of 63 drug products, that reference at least one government-interest patent in the Food and Drug Administration’s publication “Approved Drug Products with Therapeutic Equivalence Evaluations” (commonly known as the Orange Book) as of February 2024. These include 13 small molecule drug products that exclusively reference government-interest patents. Using sales data for small molecule drug products with government-interest patents, we estimate hypothetical cost savings of approximately $12.0 billion if generic competition could be introduced for small molecule drug products that reference government-interest patents in either August 2024 or at the end of exclusivity as opposed to waiting for the end of patent protection. For the set of small molecule drug products that exclusively reference government-interest patents, the savings are estimated at approximately $0.2 billion. Sensitivity analyses suggest that cost savings are lower the longer it takes to complete the march-in process.
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