FDA reports increased demand, supply efforts for estradiol transdermal patches

The FDA is working with manufacturers to increase the supply of estradiol transdermal patches after reports that patients have had difficulty obtaining their usual products, according to a news release from the agency.¹

The FDA said estradiol patches remain available, although availability may vary by product, pharmacy, and geographic location.

The agency attributed the increased demand in part to greater interest in menopausal hormone therapy (MHT) following recent changes to prescribing information. In February 2026, the FDA approved labeling changes for 6 MHT products that removed boxed warning labels regarding a probable risk of cardiovascular disease, breast cancer, and probable dementia for patients receiving these products.² The agency had initiated the labeling changes in November 2025 following a comprehensive review of the scientific literature on the safety of HRTs.²

Related: FDA approves label changes for first batch of menopausal hormone therapy products

FDA monitors estradiol patch supply

The FDA said it is working with all 6 manufacturers of estradiol transdermal patches to increase availability. Over the past year, the supply of FDA-approved estradiol patches has nearly doubled, according to the agency.

Manufacturers have reported a range of measures intended to expand supply, including adding manufacturing shifts, increasing batch sizes, expanding production capacity, installing specialized equipment and production lines, and prioritizing estradiol patch production. Some measures can increase supply relatively quickly, whereas larger manufacturing expansions may require additional time because transdermal patches require specialized equipment and manufacturing processes.

The FDA said it is also assisting manufacturers seeking to increase production and may expedite review of submissions related to supply increases when appropriate. The agency continues to monitor availability and communicate with manufacturers.

Recommendations for clinicians, patients

For clinicians prescribing estradiol patches, the immediate issue is continuity of therapy for patients who cannot obtain their usual product. The FDA recommends that patients first contact their pharmacist, who may be able to identify another FDA-approved estradiol patch that is available and clinically appropriate.

If the usual product cannot be obtained, clinicians can consider whether another estradiol formulation or route is appropriate based on the patient's indication, dose, clinical history, contraindications, and treatment goals. Patients should not independently stop or change hormone therapy because of a supply problem, according to the FDA.

The agency said it will continue working with manufacturers and monitoring supply as demand for menopausal hormone therapy evolves.

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