Estrogen patch shortage impacts menopause treatment amid skyrocketing demand

Estrogen patches are in short supply as demand for the menopause medications skyrockets, and it could take at least a year for manufacturers to catch up.

Prescriptions of estrogen patches have increased 162% over the past two years, according to data from HealthVerity. Already rising demand was turbocharged 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 pace. Three types of patches are in shortage, according to data from the American Society of Health-System Pharmacists, which relies on reports from healthcare providers. The FDA, using a different methodology, hasn't 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 difficulty their patients are experiencing to find hormone replacement therapies, particularly estrogen patches. When asked how much time she spends trying to help people find the medication, Dr. Francesca Turner, a doctor in Iowa, just laughs.

"Between my nurse, patients' pharmacists and myself, we are doing this pretty much every day trying to figure out how to navigate this for our patients," Turner said.

Doctors prescribe estrogen to treat the symptoms of menopause, including hot flashes and brain fog, which occur when a woman's body produce less of the hormone. Estradiol is the most potent type and is commonly administered through a patch that gradually releases the hormone on the skin to help ease physical and mental symptoms of menopause. Doctors prefer giving estrogen topically because it's considered a safer option than orally, Loeb-Zeitlin said.

For more than two decades, the FDA 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 conditions like dementia. Later analyses found the participants in the study were older than most women starting hormone replacement therapy and the risks of taking it were overstated. The FDA reversed course last fall and said it would work with companies to remove references to the risks in the labels of the medications.

By then, interest had already rebounded. Doctors credit prominent voices like Oprah Winfrey and social media users for shining a light on menopause, the life-altering symptoms that some women experience and how hormone replacement therapies can help.

"The demand has actually come from more of the community of women saying within their groups or communities that they are still suffering," said Dr. Jessica Shepherd, chief medical officer of Hers. "This was much more brought about by social media, where people are really able to air their voice, and you see a lot of celebrities that were talking about their journey as well."

Seeing the momentum, Hers, part of the telehealth provider Hims & Hers that's best known for offering erectile dysfunction drugs and GLP-1s, about a year and a half ago decided to get into the perimenopause and menopause business, Shepherd said. Interest in the program has tripled since the company introduced it in October, the company said.

Prescriptions of all types of estrogen have risen 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 of 2024, HealthVerity found. They now account for 44% of all estrogen prescriptions.

That popularity has strained supply.

Three types of estradiol patches are now facing shortages, according to the ASHP database. Two of the affected manufacturers – Zydus and Noven – didn't respond to CNBC's request for comment.

The third drugmaker, Amneal, said it's working to increase production to help meet growing demand. The company said it doesn't provide specific production details or timelines but remains focused on continuity of care for patients.

Other manufacturers of estrogen products said they are seeing similar trends. Sandoz in a statement said recent changes in prescribing behavior have "created an unprecedented demand that cannot be fully met at present." The company said it's working to increase manufacturing of estradiol patches, but it's challenging to do so because the patches are "highly complex" to manufacture.

The heightened demand could explain why the FDA hasn't declared a shortage, according to drug industry experts. The agency evaluates whether supply from all manufacturers of a drug meets historical demand of a drug.

And while the ASHP's shortage database is driven entirely by public reports, the FDA's data comes from manufacturers, said Michael Ganio, senior director of pharmacy practice and quality at the ASHP. That leaves the FDA trying to quantify new demand for a drug without being able to easily track prescriptions that go unfilled.

"It's really, really hard to understand how much demand is out there because you don't know how many physicians, nurse practitioners and prescribers in general are switching patients to alternate products, so it's always challenging for the FDA to put a label on yes, there's 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 report manufacturing at full capacity while working to keep up with increased 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 switch lines throughout the year, Ganio said, meaning they might dedicate a line to making an estradiol product for the first three months then be done for the year. And in order to increase output, they would either need to wait until the following year or run another batch. It's a harder calculation for generic drugmakers to make since the products carry 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, which are given alongside estrogen, as being in shortage.

In the meantime, 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 creams from compounding pharmacies.

Jenn Burch, a pharmacist in Durham, North Carolina, started marketing creams to doctors in her area earlier this year when she started struggling to stock the patches. She's finding that some patients are preferring them because she can customize them to combine estrogen with other hormones like progesterone or testosterone.

Insurers rarely cover compounded medicines, meaning patients need to 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 about compounding hazardous substances. The 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 scrambling for some time.