A woman applying an estrogen patch during hormone therapy.
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Estrogen patches are in short supply as demand for menopause drugs soars, and it could take manufacturers at least a year to catch up.
Prescriptions for estrogen patches have increased by 162% over the past two years, according to data from HealthVerity. Already high demand was further accelerated last fall when the Food and Drug Administration removed a more than 20-year-old black box warning that prevented women from receiving hormone replacement therapy.
Manufacturers are struggling to keep up with this pace. Three types of patches are in short supply, according to data from the American Society of Health-System Pharmacists, which relies on reports from health care providers. The FDA has not declared an estradiol shortage using a different method.
“It’s available, but it takes a lot of time and effort at a time when we’re all so busy,” said Dr. Susan Loeb Zeitlin, director of the Center for Women and Midlife at Weill Cornell Medicine.
Doctors across the country say their patients are experiencing difficulty finding hormone replacement therapy, especially estrogen patches. Dr. Francesca Turner, an Iowa physician, just laughs when asked how much time she spends helping people find medicine.
“We do this almost every day between the nurses, the patient’s pharmacist, and myself, figuring out how to do this for the patient,” Turner said.
Doctors prescribe estrogen to treat symptoms of menopause, such as hot flashes and brain fog, which occur when a woman’s body produces less estrogen. Estradiol is the most potent type and is commonly administered via a patch, which gradually releases hormones on the skin to relieve the physical and psychological symptoms of menopause. Doctors prefer topical administration of estrogen because it is considered a safer option than oral administration, Loeb-Zetlin said.
For more than 20 years, the FDA has advised women to avoid treating menopause with estrogen, because a 2002 study called the Women’s Health Initiative suggested that estrogen could put women at increased risk for diseases such as breast cancer and dementia. A subsequent analysis found that study participants were older than most women starting hormone replacement therapy, exaggerating the risks of receiving hormone replacement therapy. The FDA reversed course last fall, announcing it would work with companies to remove references to risks from drug labels.
By that time, interest had already returned. Doctors are crediting prominent speakers and social media users like Oprah Winfrey for shedding light on menopause, the life-altering symptoms some women experience, and how hormone replacement therapy can help.
“In fact, this demand is coming from a community of women who say they are still suffering within their own groups and communities,” said Dr. Jessica Shepard, Herds’ chief medical officer. “This has been brought about by social media where people can really make their voices heard, and we’re seeing a lot of celebrities talking about their journeys as well.”
Seeing this momentum, Herrs, part of Hims & Herrs, a telemedicine provider known for offering erectile dysfunction drugs and GLP-1, decided to move into the perimenopause and menopause business about a year and a half ago, Shepherd said. The company says interest in the program has tripled since its introduction in October.
According to data from HealthVerity, prescriptions for all types of estrogen have increased by 78% over the past two years. Patches have been particularly popular, with prescriptions more than doubling from 594,000 in June 2024 to 1.6 million in May, according to HealthVerity research. It currently accounts for 44% of all estrogen prescriptions.
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Due to its popularity, supply is tight.
According to the ASHP database, three types of estradiol patches are currently facing shortages. Two of the affected manufacturers, Zydus and Noven, did not respond to CNBC’s requests for comment.
A third drugmaker, Amneal, said it was working to increase production to meet rising demand. The company did not provide specific production details or schedules, but said it remains focused on continuing patient care.
Other estrogen product manufacturers said they are seeing similar trends. Sandoz said in a statement that recent changes in prescribing behavior have “created unprecedented demand that cannot be fully met at this time.” The company said it is working to increase production of the estradiol patch, but manufacturing it is difficult because the patch is “highly complex” to manufacture.
Rising demand may explain why the FDA hasn’t declared a shortage, pharmaceutical industry experts say. This agency assesses whether supply from all drug manufacturers meets historical demand for drugs.
Additionally, ASHP’s shortage database is driven solely by public reports, while FDA’s data comes from manufacturers, said Michael Ganio, ASHP’s senior director of pharmacy practice and quality. As a result, the FDA is trying to quantify new demand for drugs without being able to easily track unfilled prescriptions.
“It’s really, really hard to understand how much demand there is because we don’t know how many doctors, nurses and prescribers in general are switching their patients to alternative products, so it’s always difficult for the FDA to label ‘yes, there’s a shortage’ without being able to quantify the true demand in the market,” Ganio said.
An FDA spokesperson said there is currently no shortage of estradiol patches, and all six manufacturers report they are producing at full capacity to meet increased demand. The agency said it continues to monitor supplies and is providing assistance to manufacturers to increase supplies.
It may take some time to see the results of your efforts. Manufacturing transdermal patches requires more complex manufacturing than treatments such as tablets.
Ganio said generic manufacturers typically switch lines throughout the year. This means the company will have a line dedicated to manufacturing estradiol products for the first three months, with the possibility of shutting down over the next year. And to increase production, you will have to wait until the next year or run another batch. He said that for generic drug manufacturers, the profit margins on generic drugs are lower than branded drugs, so it is more difficult to calculate.
The strain appears to have already spread to other hormone replacement therapies, with ASHP recently listing some estradiol creams and progesterone pills given with estrogen as being in short supply.
In the meantime, some are looking for alternatives. Loeb Zeitlin recommends that patients try estrogen gel if they can’t find a patch. Some doctors use creams from compounding pharmacies.
Jen Birch, a pharmacist in Durham, North Carolina, started selling the cream to local doctors earlier this year when she started having trouble keeping patches in stock. She has noticed that some patients prefer them because they can be customized by combining estrogen with other hormones such as progesterone and testosterone.
Insurance companies rarely cover compounded drugs, so patients must pay out of pocket. Birch said she charges about $50 for a month’s worth of cream, a price she says helps cover the investment she’s made to comply with recent regulations on compounding hazardous substances. Ganio said special handling requirements could be another factor limiting manufacturers’ ability to quickly scale up production.
He predicts it will take manufacturers one to two years to find the sweet spot between supply and demand. That means women may be confused for a while.
