FDA says it’s working to increase estradiol patch supply

What you probably already know: Women using estradiol transdermal ​patches to treat menopause symptoms such as hot flashes, mood swings and sleep disturbances have been facing shortages of the medication. This has forced many women to search across pharmacies every time they need to refill a prescription or change brands, dosages or types of treatments. Switching may not be as simple as it sounds, since various estradiol delivery systems or even different brands of patches can affect women differently and cause unwanted side effects. Now the U.S. Food and Drug Administration (FDA) says it’s working with six manufacturers to increase supply. “It’s good news that women's health is getting the attention that it finally deserves,” says April Haberman, co-founder and CEO of MiDOViA, a company dedicated to supporting workplace menopause services, education and advocacy.

Why it matters: Demand for the patches skyrocketed after the FDA in November 2025 removed “black box” warnings that were placed on hormone replacement therapy (HRT) products in the 2000s based on a study that found a “statistically non-significant increase” in the risk of breast cancer. More recent research shows that women who begin HRT within a decade of menopause onset have a reduction in mortality and fractures. Haberman takes issue with the narrative that shortages are a demand problem. Before the warnings were implemented, she says, 40% of women were using HRT. Now that percentage is in the single digits. “I don't like the spin that they've put on that, because you should be keeping up with demand for something that women need. And they're finally getting the help that they need, they're finally using their voice, and doctors are finally prescribing it again,” she said. 

What it means: Patches from ⁠Sandoz, Viatris, Noven and Zydus are in shortage, according to data from the American Society of Health-System Pharmacists. However, the FDA hasn’t officially declared shortages, saying that the patches remain available, although supplies of certain products or brands may vary by pharmacy or location. The FDA said it’s tracking supply and ​helping manufacturers that want to increase production, including expediting reviews related to increasing supply in some cases. Companies are now prioritizing ​and increasing production of the patches and supply has nearly doubled over the past year, according to the FDA. However, women still have to spend substantial time searching out pharmacies that have the medication they need, Haberman said. “That is such a disservice … talk about inequality.”

What happens next: Manufacturers say the patches are complicated to produce and that adding capacity is difficult, according to Reuters. Sandoz said it’s allocated additional supplies for women in the U.S. to meet rising demand, while Bayer expects one Climara estradiol patch dose to be in short supply until early 2027. Viatris said it’s adding a production line and seeking third-party partners to boost supply. While recognition of the problem is a step in the right direction, women shouldn’t expect the shortages to ease right away. “We’ll see,” Haberman said. “It's good that they're talking about it. It's good that we have all the voices and the advocates that are pushing for it.”