Settlements bring more affordable medicines to market over 5 years earlier
WASHINGTON, DC (June 3, 2025) – The Association for Accessible Medicines and its Biosimilars Council today released an analysis undertaken by the IQVIA Institute for Human Data Science on behalf of AAM assessing the impact of patent settlements in expediting patient access to lower-cost medicine. The analysis shows that patent settlements between brand and generic/biosimilar medicine manufacturers accelerated patient access to generic and biosimilar medicines to market by, on average, more than five years before patent expiration. Savings to the healthcare system from patent settlements since the FTC v. Actavis decision in 2013 total $423 billion, and the average savings to the healthcare system per molecule are $5 billion.
“The ability for generic and biosimilar manufacturers to procompetitively settle with brand-name drug manufacturers creates significant savings and efficiencies and brings lower-cost medicines to patients years earlier,” said John Murphy III, President and CEO of AAM. “Efforts to severely limit patent settlements will hurt patients, cost billions of dollars, and exacerbate industry sustainability concerns in the generic medicines marketplace.”
The IQVIA Institute assessed 288 molecules for settlement information. Of those, 84 had settlements that accelerated generic or biosimilar entry by, on average, 64 months prior to patent expiration. Of those 84 settlements, 17% accelerated generic or biosimilar entry by more than a decade prior to patent expiry. The 84 molecules combined were brought to market a total of 5,365 months earlier, totaling savings for the healthcare system of $423 billion. The average savings to the healthcare system per molecule was approximately $5 billion. The graphic below summarizes these significant savings and benefits to the healthcare system:
Median Savings | $516.4 M |
Mean Savings | $5.0B |
Total Savings | $422.9B |
Median Months Prior to Patent Expiry | 56 |
Mean Months Prior to Patent Expiry | 64 |
Total Months Prior to Patent Expiry | 5,365 |
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About AAM
The Association for Accessible Medicines, your generics and biosimilars industry, is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. AAM represents the manufacturers of finished generic pharmaceuticals and biosimilars, manufacturers of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 13.1 percent of total drug spending.
About the Biosimilars Council
The Biosimilars Council, a division of the Association for Accessible Medicines, works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is the leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, government affairs, legal affairs, and regulatory policy. More information is available at biosimilarscouncil.org.
