US estrogen shortage expands beyond patches to injectable and vaginal products

Women seeking menopause hormone replacement therapy in the US face expanding estrogen shortages affecting patches, injectables, and vaginal products as of October 2026, driven by surging demand after the FDA removed a long-standing boxed warning in 2025. The American Society of Health-System Pharmacists lists multiple estradiol injection products from Hikma, American Regent, and Par Sterile Products in shortage, while vaginal creams from Viatris, Padagis, and Teva are on backorder. Demand has surged fivefold to tenfold according to Cost Plus Drugs' Mark Cuban, though FDA-approved estradiol patch supply nearly doubled over the previous year but still hasn't kept pace. Manufacturers including Viatris and Amneal are expanding production capacity with additional shifts and equipment, while healthcare providers report cascading shortages as patients switch between formulations.

Estrogen product shortages

• ▪The American Society of Health-System Pharmacists listed multiple estradiol injection products from Hikma, American Regent, and Par Sterile Products as being in shortage in early September 2026.
• ▪CVS Health reported that manufacturers have struggled over the past several months to provide sufficient supplies of certain strengths of estradiol injections, with the situation worsening in recent weeks as of October 2026.
• ▪Women in the US are facing shortages of injectable and vaginal estrogen products beyond estrogen patches as of October 2026.
• ▪Kevin Schipper of ProPharma suggested that the new estrogen shortages may partly reflect women switching from patches that have become harder to find to alternative hormone therapy products.
• ▪The American Society of Health-System Pharmacists lists vaginal estradiol creams made by Viatris' Mylan unit, Padagis, and Teva as being on backorder or allocation as of October 2026.

FDA hormone therapy warning removal

• ▪The US Food and Drug Administration removed a long-standing boxed warning on some hormone therapy in 2025 that had signaled possible heightened risk of breast and ovarian cancer, as well as strokes and other serious conditions found in a large 2002 study.
• ▪Demand for hormone replacement therapy increased following the FDA's removal of the boxed warning on some hormone therapy in 2025.

Manufacturer supply responses

• ▪Viatris is pursuing potential partnerships with third parties to further increase estrogen patch supply.
• ▪Amneal is working to increase production of estradiol patches following significantly increased demand after the FDA's warning removal.
• ▪Viatris added a production shift at its St. Albans, Vermont facility earlier in 2026, taking the plant to around-the-clock production.
• ▪Viatris stated it is meeting its current supply plans for estradiol vaginal cream as of October 2026.
• ▪Viatris is investing in additional equipment and adding a new production line to expand long-term capacity for estrogen products.

Pharmacy access challenges

• ▪Dr. Kathleen Jordan of Midi Health described a growing number of supply-chain issues where persistent patch shortages have led prescribers and patients to switch to alternative gels and creams, creating a domino effect impacting supplies of these prescriptions.
• ▪Cost Plus Drugs has been able to maintain estrogen replacement supplies with only intermittent interruptions as of October 2026.

Demand surge for estrogen

• ▪Mark Cuban reported that demand for estrogen products sold through Cost Plus Drugs had surged fivefold to tenfold for almost every product as of October 2026.
• ▪Viatris reported seeing a significant surge in demand for estrogen products throughout 2026.
• ▪The FDA reported in September 2026 that the US supply of FDA-approved estradiol patches had nearly doubled over the previous year but had not kept up with demand.

Supply-chain production issues

• ▪Kevin Schipper of ProPharma stated that the pattern of estrogen shortages did not appear to point to a broad lack of raw materials, though supply-chain problems could still be contributing to disruptions.
• ▪The US Food and Drug Administration has been working with manufacturers since September 2026 to boost supplies of estrogen patches after months of shortages.
• ▪Cost Plus Drugs is buying as much estrogen product as possible from suppliers to maintain inventory levels as of October 2026.