FDA working with manufacturers to increase access to estradiol transdermal patches

The FDA stated this week that it is aware of multiple reports that patients are struggling to access their usual amount of estradiol transdermal patches because of increased demand, and that the agency is working with all 6 patch manufacturers to increase supply.¹

FDA acknowledges difficulty accessing patches

“Although availability of certain products or brands may vary by pharmacy or location, estradiol transdermal patches remain available,” the FDA stated, adding that it continuously monitors supply. The manufacturers, which were not named in the update from the FDA, are getting assistance from the governing body that includes:

• increases in production
• addition of manufacturing shifts
• expanding production capacity
• increasing batch sizes
• addition of specialized equipment and manufacturing lines
• priority for estradiol patch production

The FDA noted that “some of these actions can help increase supply in the near term… larger manufacturing expansions may take more time because transdermal patches require specialized equipment and manufacturing processes.”

Increased demand after label changes

National reports of difficulty accessing estradiol patches, which deliver a consistent stream of estrogen to the body, began early in 2026, as the FDA stated that more women have sought patch treatment for symptoms of menopause.^1,2

Menopausal hormone therapies are approved by the FDA to treat various symptoms associated with menopause, including vasomotor symptoms. According to the FDA, increased demand occurred after action by the FDA in November 2025, which requested that manufacturers update labeling to remove boxed warnings about the probable risk of breast cancer, cardiovascular disease, and probable dementia for patients who received hormonal therapy products for menopause.

In the update from the FDA, the agency does not use “shortage” in its language; however, as reported by CBS News, lawmakers in July 2026 wrote a letter to the FDA in an effort to add estradio patches to the federal drug shortage database. The letter read in part, “The FDA relies on historic demand data to determine if drug manufacturers are keeping pace, and these data may be lagging given how quickly demand for the patches has spiked.”³

“The FDA views increased interest in menopause treatment as an important development for women’s health and is working closely with manufacturers to help ensure that the supply of estradiol patches keeps pace with demand,” the agency wrote.¹

Going forward, the agency stated it will remain in contact with manufacturers and is closely monitoring the supply of estradiol transdermal patches.

References:

1. FDA update on estradiol transdermal patch availability. FDA. News release. Published September 3, 2026. Accessed September 4, 2026. https://www.fda.gov/drugs/drug-alerts-and-statements/fda-update-estradiol-transdermal-patch-availability
2. Howard J. Estrogen patches in short supply as demand for menopause hormone therapy grows. CNN. Published February 23, 2026. Accessed September 4, 2026. https://www.cnn.com/2026/02/23/health/estrogen-patch-shortage-menopause-hormone-therapy-wellness
3. Lazar K, Corral A. Estrogen patch shortage prompts doctors, lawmakers to seek FDA action as women struggle to find treatment. CBS News. Published September 3, 2026. Accessed September 4, 2026. https://www.cbsnews.com/news/estrogen-patch-shortage-fda-declaration-hormone-replacement-therapy/