Full Breakdown
U.S. Estrogen Patch Shortages Ripple to Injections and Creams
By Drooid · · How we work
In this breakdown
01
Expanding Shortages of Estrogen Therapies
Women seeking hormone-replacement therapy for menopause are encountering shortages not only of transdermal estradiol patches but also of injectable estradiol products and vaginal estradiol creams. The American Society of Health-System Pharmacists reported that multiple injection products from Hikma, American Regent and Par Sterile Products are in shortage, while vaginal creams produced by Viatris’ Mylan unit, Padagis and Teva are on back-order or allocated.
02
Drivers of Increased Demand
Demand surged after the U.S. Food and Drug Administration removed a boxed warning last year that had highlighted elevated risks of breast and ovarian cancer, stroke and other serious conditions associated with certain hormone therapies. The warning’s removal has prompted many prescribers and patients to shift toward estrogen products, intensifying pressure on already constrained supplies.
03
Manufacturer Responses and Supply Efforts
Viatris said it has seen a “significant surge in demand” and has moved its St. Albans, Vermont facility to near-continuous production, adding equipment and a new line to expand long-term capacity. Amneal reported similar demand growth and is working to raise output. Cost Plus Drugs, the online pharmacy founded by Mark Cuban, has been purchasing aggressively from suppliers, noting a five- to ten-fold increase in demand for its low-price offerings. CVS Health indicated that manufacturers have struggled to provide sufficient quantities of certain estradiol injection strengths, a problem that has worsened in recent weeks.
04
Supply-Chain Constraints
Dr. Kathleen Jordan, chief medical officer of telehealth provider Midi Health, described a “domino effect” in which persistent patch shortages push prescribers toward gels and creams, further straining those product lines. The FDA has not commented on the latest shortages, though it announced in September that it is working with manufacturers to boost estradiol-patch supplies.
05
Verbatim Quotes
- “We are meeting our current supply plans for estradiol vaginal cream and are committed to supporting patient access to this needed treatment,” — Viatris
06
Outlook
The FDA continues to coordinate with manufacturers to increase estradiol-patch production, but no specific timeline for resolving the broader shortages has been provided. Stakeholders are monitoring inventory levels as demand remains elevated.