Key Highlights

  • The FDA said it is working with all six manufacturers of estradiol transdermal patches to increase Supply after patients reported difficulty accessing the menopause treatment.
  • More than 1 million US women begin menopause each year, with Demand surging after the FDA removed a longstanding boxed warning on hormone therapy products.
  • Manufacturers including Bayer and Viatris say the patches are complex to produce, requiring specialized equipment that is slow to scale.
  • Patches from Sandoz, Viatris, Noven and Zydus are currently listed in shortage, according to data from the American Society of Health-System Pharmacists.

Regulators Respond to Growing Access Concerns

The US health regulator said it is working with all six manufacturers to increase the supply of estradiol transdermal patches, used to treat menopause symptoms, after reports of patients having difficulty readily accessing them. A surge in demand for estrogen patches has strained supplies and led to shortages in recent months.

While the FDA has not formally designated the patches as being in shortage, women have reportedly been pharmacy-hopping in search of their prescriptions, reducing or switching dosages, and changing brands or types of therapy. Estradiol transdermal patches, which deliver the estrogen hormone directly into the bloodstream, are used to ease menopause symptoms such as mood swings, hot flashes and sleep disturbances.

Demand Surged After a Regulatory Change

More than 1 million US women begin menopause each year, and demand for these products increased significantly after the FDA removed the long-standing boxed warning that had highlighted risks such as cardiovascular disease, breast cancer and probable dementia associated with hormone therapy. The regulator said that although availability of certain products or brands may vary by pharmacy or location, estradiol transdermal patches generally remain available. The FDA did not name the specific manufacturers it is working with.

Manufacturers Describe Production Challenges

Companies including Amneal, Sandoz, Noven, Bayer, Zydus and Viatris sell estradiol patches in the US market. A spokesperson for Sandoz said hormone replacement therapy patches are complex to manufacture and that expanding capacity is difficult, adding that the company has allocated additional supplies for women in the US to help meet rising demand.

Bayer said in a statement that it expects to experience temporary supply constraints affecting one dose of its Climara estradiol patch until early 2027. Viatris told reporters that estradiol patches require specialized equipment that is slow to scale, and that the company is adding a new production line and seeking third-party partners to boost supply. The remaining manufacturers did not immediately respond to requests for comment.

Which Products Are Currently Affected

Data from the American Society of Health-System Pharmacists show that patches from Sandoz, Viatris, Noven and Zydus are currently listed in shortage. The FDA said the affected companies are responding by increasing production, adding Manufacturing shifts, expanding production capacity, increasing batch sizes, adding specialized equipment and manufacturing lines, and prioritizing production of the patches specifically.

Ongoing Monitoring and Support

The regulator said it is monitoring the supply situation and offering assistance to manufacturers seeking to increase production, including expediting the review of submissions related to boosting supply when appropriate. Given that manufacturers have described the underlying production challenges as complex and difficult to scale quickly, it remains uncertain how soon patients experiencing access difficulties will see meaningful relief, even with regulatory support aimed at accelerating the response.