Estradiol patches stay on US shortage list even as output doubles

Patches remain on the shortage list

ASHP lists estradiol transdermal systems as an active shortage. Its full name is the American Society of Health-System Pharmacists.

Products from Amneal, Noven, Sandoz, Viatris and Zydus are backordered, on allocation or released intermittently, The People's Pharmacy reported on 2 November. The FDA says patch output has roughly doubled in the last 12 months. The agency acknowledges localized difficulty in finding usual menopausal hormone therapy products. It says it is engaging all six manufacturers of FDA-approved estradiol patches to address access problems driven by a rise in demand.

For patients, a doubled national total is little comfort if their dose and brand are missing at their pharmacy. Switching can push more demand onto gels, creams and injections.

Demand jumped after the warning change

The surge traces back to a labelling decision. In 2025 the FDA removed a long-standing boxed warning on some hormone therapy that had flagged possible risks of breast and ovarian cancer and strokes.

Demand for menopausal hormone therapy rose after that change. PwC put the menopause market at about $15 billion, and expects growth of 8% to 10% a year to 2030, Handelsblatt reported. The number of women in menopause worldwide is projected to reach 1.2 billion by 2030.

Shortages spread to other forms

The gaps now extend beyond patches.

ASHP listed multiple estradiol injection products from Hikma, American Regent and Par Sterile Products as in shortage early in September. Vaginal estradiol creams are on back order or allocation. The makers are Mylan, Padagis and Teva. CVS Health said manufacturers struggled for several months to supply certain strengths of estradiol injections, and that the situation worsened in recent weeks. Kathleen Jordan, chief medical officer of telehealth provider Midi Health, described a domino effect as patients and prescribers turned to gels and creams.

Manufacturers add capacity

Viatris added a production shift at its St. Albans, Vermont, facility this year, taking the plant to around-the-clock production, and said its output was significantly higher. The company is investing in additional equipment and a new production line, and is pursuing third-party partnerships to raise patch supply. Amneal said demand increased significantly after the FDA removed the warning and that it is working to increase production. The FDA says manufacturers have expanded capacity. They added shifts and prioritised patch output.

Cost Plus Drugs said demand rose fivefold to tenfold for almost every product it sells. The online pharmacy reported only intermittent interruptions to its estrogen supplies.

What is still unknown

Some manufacturers cannot say when their backorders will clear, and the FDA has not declared a nationwide shortage.

The agency says it continues to monitor supply of gels and creams. It directs women who cannot find their usual patch to a pharmacist or healthcare provider, who may identify an available alternative.