Woman applying estrogen patch during hormone treatment.
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Estrogen patches are in short supply as demand for menopause drugs skyrockets, and it may take at least a year for manufacturers to catch up.
Prescriptions for estrogen patches have increased 162% over the past two years, according to HealthVerity data. Already growing demand accelerated last fall when the Food and Drug Administration removed a more than 20-year-old black box warning discouraging women from taking hormone replacement therapy.
Manufacturers are struggling to keep up. Three types of patches are in shortage, according to data from the American Society of Health-System Pharmacists, which draws on reports from health care providers. The FDA, using a different methodology, has not declared a shortage of estradiol.
“You can get them, but it takes a lot of time and effort when we’re all so busy at this time of our lives,” said Dr. Susan Loeb-Zeitlin, director of the Women’s Midlife Center at Weill Cornell Medicine.
Doctors across the country describe the difficulties their patients face finding hormone replacement therapies, particularly estrogen patches. When asked how much time she spends trying to help people find the drug, Iowa physician Dr. Francesca Turner just laughs.
“Between my nurse, the patient pharmacists and myself, we do this almost every day trying to figure out how to manage this for our patients,” Turner said.
Doctors prescribe estrogen to treat menopausal symptoms, including hot flashes and brain fog, which occur when a woman’s body produces less of the hormone. Estradiol is the most potent type and is commonly administered through a patch that gradually releases the hormone onto the skin to help relieve the physical and mental symptoms of menopause. Doctors prefer to administer estrogen topically because it is considered a safer option than orally, Loeb-Zeitlin said.
For more than two decades, the FDA has advised women to avoid treating menopause with estrogen because a 2002 study called the Women’s Health Initiative suggested it could put women at greater risk of breast cancer and other diseases like dementia. Subsequent analyzes revealed that the study participants were older than most women starting hormone replacement therapy and that the risks of this treatment were overestimated. The FDA changed course last fall and said it would work with companies to remove references to risks from drug labels.
By then, interest had already rebounded. Doctors credit prominent voices like Oprah Winfrey and social media users for shedding light on menopause, the symptoms that alter some women’s lives and how hormone replacement therapies can help.
“The demand is actually coming from more women saying within their groups or communities that they are still suffering,” said Dr. Jessica Shepherd, Hers’ chief medical officer. “It’s been a lot more driven by social media, where people can actually express their voice, and you see a lot of celebrities talking about their journey as well.”
Seeing that momentum, Hers, part of telehealth provider Hims & Hers, best known for offering erectile dysfunction and GLP-1 medications, decided about a year and a half ago to get into the perimenopause and menopause business, Shepherd said. Interest in the program has tripled since its introduction in October, the company said.
Prescriptions for all types of estrogen have increased 78% over the past two years, according to HealthVerity data. The patches have proven particularly popular, with prescriptions more than doubling to 1.6 million in May, up from 594,000 in June 2024, according to HealthVerity. They now account for 44% of all estrogen prescriptions.
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This popularity has put a strain on supply.
Three types of estradiol patches are now facing shortages, according to the ASHP database. Two of the affected manufacturers – Zydus and Noven – did not respond to CNBC’s request for comment.
The third drugmaker, Amneal, said it was working to increase production to meet growing demand. The company said it was not providing details or specific production timelines, but remained focused on continuity of care for patients.
Other manufacturers of estrogen products have said they are seeing similar trends. Sandoz said in a statement that recent changes in prescribing behaviors have “created unprecedented demand that cannot be fully met at this time.” The company said it was working to increase manufacturing of estradiol patches, but that this was difficult to achieve because the patches are “very complex” to manufacture.
The increased demand could explain why the FDA has not declared a shortage, according to pharmaceutical industry experts. The agency evaluates whether supply from all manufacturers of a drug meets historical demand for a drug.
And while ASHP’s shortage database relies entirely on public reporting, the FDA’s data comes from manufacturers, said Michael Ganio, senior director of pharmacy practices and quality at ASHP. This requires the FDA to attempt to quantify new demand for a drug without being able to easily track unfilled prescriptions.
“It’s really, really difficult to understand how much demand there is, because you don’t know how many doctors and nurse practitioners and prescribers in general are switching their patients to other products. So it’s still difficult for the FDA to put a label on yes, there is a shortage, without really being able to quantify the true market demand,” Ganio said.
An FDA spokesperson said estradiol patches are currently not in shortage and all six manufacturers say they are manufacturing at full capacity while working to meet growing demand. The agency said it continues to monitor supply and is offering assistance to manufacturers to increase supply.
It may take time to see the results of this effort. Manufacturing transdermal patches involves more complex manufacturing than treatments like pills.
Generic makers typically change lines throughout the year, Ganio said, meaning they might dedicate one line to making an estradiol product for the first three months and then for the entire year. And to increase production, they should either wait for the next step year or run another batch. That’s a tougher calculation for generic drugmakers to make because the products generate lower profit margins than brand-name drugs, he said.
The strain already appears to be spreading to other hormone replacement therapies, with ASHP recently listing several estradiol creams and progesterone pills, administered alongside estrogen, as being in shortage.
In the meantime, some are looking for alternatives. Loeb-Zeitlin suggests her patients try estrogen gels if they can’t find patches. Some doctors turn to creams from pharmaceutical pharmacies.
Jenn Burch, a pharmacist in Durham, North Carolina, began marketing creams to doctors in her area earlier this year, when she began having trouble storing the patches. She finds that some patients prefer them because she can customize them to combine estrogen with other hormones like progesterone or testosterone.
Insurers rarely cover compounded medications, meaning patients must pay out of pocket. Burch says she charges about $50 for a month’s supply of cream, a price she says helps cover the investment she made to comply with a recent regulation on the composition of hazardous substances. Special handling requirements could be another factor limiting manufacturers’ ability to quickly ramp up production, Ganio said.
He predicts it will take a year or two for manufacturers to find the right balance between supply and demand. This means that women could find themselves in a difficult situation for a while.