AAM highlights essential role generics manufacturers play in supplying estrogen patches; notes the complexity of its production and reasons for not declaring a nationwide shortage
WASHINGTON (October 14, 2026) — The Association for Accessible Medicines and the Biosimilars Council today highlighted the key role generic medicines manufacturers, led by several AAM member companies, are playing in ramping up the supply of estrogen patches as demand has dramatically increased.
Last month, the FDA announced demand for estrogen patches has dramatically increased in the U.S. and detailed its activities for addressing that increased demand. The announcement cited a February 2026 FDA labeling update providing additional and updated labeling information for estrogen therapy products, which may have contributed to the recent increase in demand.
According to an AAM analysis of IQVIA data, from January 2025 to June 2026, the number of prescriptions for dispensed estrogen patches doubled – from 1.8 million prescriptions to 3.6 million prescriptions. A large majority of that increase was met by AAM member companies – Amneal, Sandoz, and Zydus. Generic manufacturer Mylan/Viatris has increased supply as well.
While Americans are often aware of the cost-savings provided by generic medicines, they may not be aware of the various ways in which generic manufacturers have contributed to supply chain resiliency by increasing production or reallocating global supply to help meet demand.
“Largely due to generic manufacturers willingness to step up when patient demand increases, individuals living in the US have increased access to estrogen patches,” John Murphy III said. “But, given the complexity of manufacturing estrogen patches and the increased demand, it may be a while longer before estrogen patch manufacturers can meet the full domestic demand.”
The FDA notes that the agency has taken steps to increase the supply of estrogen patches. In other circumstances, declaring a nationwide drug shortage could increase patient access by allowing compounding entities to make the products in shortage. However, given the technical expertise to produce the complex transdermal system required by estrogen patches, compounding entities are unlikely to meet that demand. Those entities can and do provide other topical formulations of estrogen.
Each patch is a sophisticated, multilayer system that combines the active pharmaceutical ingredient, adhesives, protective backing materials and other components. These elements work together to ensure safe and effective delivery of the medicine.
AAM acknowledges that coordinated support from policymakers and the Administration, across several key areas, will result in more stable generic medicines market. AAM and its member companies always welcome opportunities to explore policies and partnerships that support expanded manufacturing in ways that strengthen American supply chain resilience, healthcare stability and national security.
2026 U.S. Generic & Biosimilar Medicines Savings Report
Media contact: media@accessiblemeds.org
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 12 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 www.biosimilarscouncil.org.
