FDA Approves First Generic Version of a Once-Weekly Menopause Hormone Patch

The Food and Drug Administration on Oct. 20 approved the first generic version of Climara Pro, a once-weekly combination estrogen-progestogen patch used to treat menopause symptoms, a move that adds a lower-cost option to a hormone therapy market now struggling to keep pace with a sharp rise in demand.

The generic, made by Zydus Pharmaceuticals and delivering 0.045 milligrams of estradiol and 0.015 milligrams of levonorgestrel per day, is intended for women with an intact uterus who need treatment for moderate to severe hot flashes and night sweats and for prevention of postmenopausal osteoporosis. The FDA found it therapeutically equivalent to the brand-name Bayer product, meaning pharmacists can substitute it without a new prescription in most states.

"Menopause is a universal experience for women, and it can greatly affect a person's quality of life," acting FDA Commissioner Kyle Diamantas said in the agency's announcement, which also noted that roughly nine in 10 prescriptions filled in the United States are already for generic drugs. Michael Davis, director of the FDA's Center for Drug Evaluation and Research, added that "once-weekly dosing can make a real difference in how patients manage their care," according to the release and trade coverage of the approval.

A Lifted Warning Changed the Market

The approval lands eight months after the FDA began unwinding one of its longest-standing drug safety warnings. In a Feb. 12 announcement, the agency approved labeling changes for six menopausal hormone therapy products, removing cardiovascular disease, breast cancer and "probable dementia" language from their boxed warnings, the strongest safety alert the FDA places on a drug label. The agency said it asked 29 drug companies to submit revised labeling after a review of the scientific literature, and the six approvals were the first batch to go through; the labels for estrogen-only products still carry a boxed warning about endometrial cancer risk in women with a uterus.

The FDA's own figures, cited in that release, illustrate how much headroom exists in the market: an estimated 41 million women in the United States were ages 45 to 64 as of 2020, but only about 2 million women in a similar age range were filling a hormone therapy prescription. For decades, use of menopausal hormone therapy had stayed depressed following a 2002 federal study that linked it to cardiovascular and cancer risks later shown to apply mainly to older women starting therapy years after menopause.

Supply Has Not Kept Up

Once the warning changes took hold last fall, prescribing accelerated quickly. Estradiol patch use rose 26% in the first two months of this year alone and 184% since 2023, according to data from the health analytics firm Truveta cited by HealthDay, which reported that shortages of the patches could persist for up to three years. The FDA has said the supply of agency-approved estradiol transdermal patches has nearly doubled over the past year as all six manufacturers add shifts, equipment and production lines, but it has stopped short of listing the product on its official drug shortage database, saying availability varies by brand, pharmacy and region.

That gap between what patients are experiencing and what the FDA's database shows has drawn pushback from Capitol Hill. Rep. Debbie Dingell of Michigan and seven House colleagues sent the agency a letter in early August asking it to formally designate an estradiol patch shortage, arguing that the current listing understates how hard the products are to find. The American Society of Health-System Pharmacists, which tracks shortages based on reports from providers rather than manufacturers, has listed multiple estradiol patch strengths from several companies as on back order with no estimated release date.

• 41 million: estimated number of U.S. women ages 45 to 64 as of 2020, per the FDA
• 2 million: women in a similar age range filling a hormone therapy prescription, per the same FDA release
• 184%: rise in estradiol patch use since 2023, per Truveta data reported by HealthDay
• 6: hormone therapy products that had boxed-warning language removed in the FDA's first round of label changes in February

Doctors See Progress, With Caveats

Physicians who treat menopause patients describe the moment as a welcome reversal after two decades of caution, tempered by the reality that many patients still cannot get the product their doctor prescribes. "For 20 years, less than 5% of women took hormone therapy," Dr. Gillian Goddard, an adjunct assistant professor at NYU Grossman School of Medicine, told reporters this spring, before the shortage worsened. Dr. Mary Rosser, an obstetrician-gynecologist who directs integrated women's health at Columbia University, has described patients who finally decide to start therapy only to find pharmacies without stock.

"Menopause is a universal experience for women, and it can greatly affect a person's quality of life."

That quote, from acting Commissioner Diamantas, frames how the agency is positioning the new generic: as a step toward making an already-approved category of medicine more affordable and easier to find, even as it maintains that the underlying supply problem does not meet the bar for an official shortage designation. A Sandoz spokesperson, one of the six manufacturers making estradiol patches, has said the November label change "created unprecedented demand that cannot fully be met at present," according to reporting on the generic approval.

What Happens Next

Zydus has not announced a launch date or price for its generic patch, and generics typically take weeks to months to reach pharmacy shelves after approval. The FDA has said it continues to work with all six estradiol patch manufacturers on capacity expansions, including larger batch sizes and new production lines, though officials have cautioned that specialized patch-manufacturing equipment makes scaling up slower than for pills or injections. Lawmakers pressing for an official shortage designation have not received a public response describing a timeline, and the FDA's labeling review of the remaining menopausal hormone products requested from the other 23 companies is ongoing, with additional label changes expected in future rounds. For now, physicians are advising patients who cannot find their usual patch to contact their prescriber about alternative doses, brands or forms, including hormone creams, rather than going without treatment.