Woman applying estrogen patch during hormone therapy.
Half point images | Moment | fake images
Estrogen patches are in short supply as demand for menopause drugs skyrockets, and it could take manufacturers at least a year to catch up.
Estrogen patch prescriptions have increased 162% over the past two years, according to data from HealthVerity. The already growing demand accelerated last fall when the Food and Drug Administration removed a more than 20-year-old black box warning that discouraged women from taking hormone replacement therapy.
Manufacturers are struggling to keep up. There are shortages of three types of patches, according to data from the American Society of Health-System Pharmacists, which is based on reports from health care providers. The FDA, using a different methodology, has not declared a shortage of estradiol.
“They can be done, but it takes a lot of time and effort when we're all so busy at this time in our lives,” said Dr. Susan Loeb-Zeitlin, director of the Midlife Women's Center at Weill Cornell Medicine.
Doctors across the country describe the difficulties their patients experience finding hormone replacement therapies, particularly estrogen patches. When asked how much time she spends helping people find the medicine, Iowa physician Dr. Francesca Turner simply laughs.
“Between my nurse, the patients' pharmacists and I, we do this almost every day trying to figure out how to manage this for our patients,” Turner said.
Doctors prescribe estrogen to treat menopause 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 into 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 recommended women avoid treating menopause with estrogen because a 2002 study called the Women's Health Initiative suggested it could put women at higher risk for breast cancer and other conditions such as dementia. Further analysis found that the study participants were older than most women starting hormone replacement therapy and that the risks of taking it were exaggerated. 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 recovered. Doctors credit prominent voices like Oprah Winfrey and social media users for shedding light on menopause, the life-altering symptoms some women experience, and how hormone replacement therapies can help.
“The demand is actually coming from a larger part of the community of women saying within their groups or communities that they are still suffering,” said Dr. Jessica Shepherd, medical director at Hers. “This was much more due to social media, where people can really express their voice and you see a lot of celebrities who were also talking about their journey.”
Seeing the momentum, Hers, part of the telehealth provider Hims & Hers, best known for offering erectile dysfunction drugs and GLP-1, decided about a year and a half ago to enter the perimenopause and menopause business, Shepherd said. Interest in the program has tripled since the company introduced it in October, the company said.
Prescriptions for all types of estrogen have increased 78% over the past two years, according to data from HealthVerity. The patches have proven particularly popular, with prescriptions more than doubling to 1.6 million in May from 594,000 in June 2024, HealthVerity found. They currently account for 44% of all estrogen prescriptions.
Phynart Studio | E+ | fake images
That popularity has strained supply.
According to the ASHP database, there are currently shortages of three types of estradiol patches. Two of the affected manufacturers, Zydus and Noven, did not respond to CNBC's request for comment.
The third drugmaker, Amneal, said it is working to increase production to help meet growing demand. The company said it is not providing specific production details or timelines, but continues to focus on continuity of patient care.
Other makers of estrogen products said they are seeing similar trends. Sandoz in a statement said recent changes in prescribing behavior have “created unprecedented demand that cannot be fully met at present.” The company said it is working to increase manufacturing of estradiol patches, but it is challenging to do so 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 all manufacturers' supply of a drug meets the historical demand for a drug.
And while ASHP's shortage database is based entirely on public reporting, the FDA's data comes from manufacturers, said Michael Ganio, ASHP's senior director of pharmaceutical practice and quality. That leaves the FDA trying to quantify new demand for a drug without being able to easily track prescriptions that aren't filled.
“It's very, very difficult to understand how much demand there is because you don't know how many doctors, nurse practitioners and prescribers in general are switching patients to alternative products, so it's always a challenge for the FDA to put a label that says yes, there is a shortage, without being able to really quantify the true market demand,” Ganio said.
An FDA spokesperson said there is currently no shortage of estradiol patches and that all six manufacturers report manufacturing at full capacity as they work to keep up with growing demand. The agency said it continues to monitor supply and is offering assistance to manufacturers to increase supply.
It could take time to see the result of that effort. Making transdermal patches involves more complex manufacturing than treatments like pills.
Generic manufacturers 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 dedicate it to making an estradiol product for the first three months and then do so year-round. And to increase production, they would have to wait until the next year or run another batch. It's a more difficult calculation for generic drug makers to make, since the products have lower profit margins than brand-name drugs, he said.
The strain already appears to be spreading to other hormone replacement therapies, and ASHP recently mentioned that there are shortages of several estradiol creams and progesterone pills, which are given along with estrogen.
Meanwhile, some people are looking for alternatives. Loeb-Zeitlin suggests her patients try estrogen gels if they can't find patches. Some doctors are turning to compounded pharmacy creams.
Jenn Burch, a pharmacist in Durham, North Carolina, began marketing creams to doctors in her area earlier this year when she began having trouble stocking up on patches. She is finding that some patients prefer them because she can customize them to combine estrogen with other hormones such as 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 has 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 sweet spot between supply and demand. That means women could be left fighting for some time.
