The FDA is working with all six manufacturers of estradiol transdermal patches to increase supply amid reports that patients are having difficulty accessing their usual patches.
Estradiol transdermal patches remain available, though availability of certain products or brands may vary by pharmacy or location, according to a Sept. 3 FDA update. The agency said it is offering assistance to manufacturers seeking to increase production, including expedited reviews of submissions related to supply increases, when appropriate.
The update follows months of disputes over whether a shortage exists. The FDA has maintained that estradiol patches do not meet its criteria for an official shortage designation, even as the American Society of Health-System Pharmacists’ shortage database — which relies on provider-reported data rather than the FDA’s manufacturer-based methodology — has listed multiple estradiol patch products as in short supply.
Over the last year, the supply of FDA-approved estradiol transdermal patches has nearly doubled. Manufacturers are increasing production, adding manufacturing shifts, expanding production capacity and batch sizes, adding specialized equipment and manufacturing lines and prioritizing estradiol patch production.
The FDA attributed increased demand to more women seeking treatment for menopause symptoms. Demand increased following the FDA’s November 2025 request for labeling changes to remove boxed warnings about the risk of breast cancer, cardiovascular disease and probable dementia for patients receiving menopausal hormone therapy products.
The FDA said it will continue monitoring supply and working with manufacturers to increase availability.
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