Patent Settlements Slash Drug Costs and Expedite Access by Over 5 Years, Study Finds
A new analysis from the IQVIA Institute for Human Data Science, commissioned by the Association for Accessible Medicines (AAM) and its Biosimilars Council, reveals that patent settlements between brand-name and generic or biosimilar drugmakers are significantly advancing patient access to affordable medicines.
The report, examining 288 molecules, found that 84 settlements accelerated market entry of lower-cost alternatives by an average of 64 months—more than five years—prior to patent expiration. In 17% of these cases, entry was accelerated by over a decade. This early competition has produced $423 billion in total health care savings since the 2013 FTC v. Actavis ruling, with median savings per molecule at $516 million and average savings reaching $5 billion.
John Murphy III, AAM president and CEO, emphasized the broader implications for health care systems and policy: “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.”
Payers and managed care leaders should be aware of the potential policy risks associated with restricting patent settlements, as doing so could delay access to cost-saving generics. Coverage decisions may benefit from recognizing the established role these settlements play in facilitating earlier biosimilar availability. Additionally, benefit design strategies could be enhanced by leveraging the accelerated market entry timelines resulting from such agreements.
This analysis strongly supports preserving the legal and regulatory flexibility that enables settlements as a tool for improving affordability and patient access.
Reference
Generic and biosimilar patent settlements save $423 billion. Association for Accessible Medicines. June 3, 2025. Accessed July 10, 2025. https://accessiblemeds.org/resources/press-releases/generic-and-biosimilar-patent-settlements-save-423-billion/
