Women across the United States are increasingly finding empty pharmacy shelves as demand for estrogen patches continues to outpace supply following a major change in federal health guidance. The shortage began after the Food and Drug Administration (FDA) removed a more than 20-year-old boxed warning from hormone therapy products last November, triggering a sharp increase in prescriptions that manufacturers have struggled to meet.
According to healthcare data firm HealthVerity, prescriptions for estrogen patches have surged 162% over the past two years, climbing to approximately 1.6 million prescriptions in May from about 594,000 in June 2024. Estrogen patches now account for nearly half of all estrogen prescriptions written in the United States.
The renewed interest marks a dramatic reversal from two decades ago.
Following publication of the Women’s Health Initiative study in 2002, millions of women stopped using hormone replacement therapy after research suggested increased risks of breast cancer, heart disease and stroke.
Subsequent research found those risks were far more limited than originally believed and primarily affected women who began hormone therapy later in life rather than during menopause.
Last year, the FDA removed the strongest warning labels from many hormone therapy products, reflecting updated medical evidence.
FDA Commissioner Marty Makary said the change released years of pent-up demand from women who had previously avoided treatment because of safety concerns.
Physicians say the patient population has also changed.
Many women now begin hormone therapy earlier—often during their 40s—and continue treatment significantly longer than previous medical recommendations, with some remaining on therapy into their 60s and 70s.
That shift has increased the number of monthly prescription refills, placing additional strain on manufacturers.
Estrogen patches have become especially popular because they deliver medication through the skin rather than the digestive system, are generally well covered by insurance and are considered by many physicians to have advantages over oral hormone therapies.
Manufacturers, however, have been unable to expand production quickly enough.
Several estradiol patch products currently appear on shortage lists maintained by the American Society of Health-System Pharmacists, while CVS has confirmed ongoing supply disruptions from manufacturers.
Drug companies acknowledge the unprecedented demand.
Sandoz said the FDA’s policy change created demand far beyond historical levels and that it has increased shipments to the United States.
Amneal Pharmaceuticals and Viatris also say they are expanding production capacity.
Even so, many manufacturers expect intermittent shortages to continue through at least late 2026, with some industry observers warning recovery could take even longer.
Interestingly, the federal government has not declared an official nationwide shortage.
The Department of Health and Human Services says all major manufacturers continue operating at full production, while the FDA has not added estrogen patches to its formal drug-shortage database.
That difference has frustrated physicians, pharmacists and patients who continue encountering empty pharmacy inventories despite the absence of an official shortage designation.
A survey conducted by telehealth provider Midi Health found that nearly one out of every two women seeking estrogen patches reported difficulty filling their prescriptions.
The shortage has also created new business opportunities.
Growing awareness of menopause care has fueled rapid expansion among telehealth providers and women’s health companies.
Hers, the women’s health division of Hims & Hers, entered the menopause treatment market about eighteen months ago and says patient interest has tripled since launch.
Drug manufacturers, pharmacies and digital healthcare companies are increasingly investing in menopause services as millions of women seek treatment previously avoided for decades.
For patients currently affected by shortages, physicians recommend contacting healthcare providers rather than discontinuing therapy without medical supervision.
Alternative treatments—including estrogen gels, sprays and oral medications—remain available through separate manufacturing supply chains and have experienced fewer shortages.
Healthcare providers emphasize that any change in hormone therapy should be made only after consultation with a physician or pharmacist familiar with the patient’s medical history.
JBizNews Desk
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