FDA Approves First Generic of Weekly Combination Menopause Hormone Patch

The FDA has approved a generic version made by Zydus Pharmaceuticals, according to Healio, which cited an agency press release. The FDA rates it as the therapeutic equivalent of Climara Pro. It is the first generic version of that product the agency has approved.

The patch delivers estradiol at 0.045 mg per day and levonorgestrel at 0.015 mg. It is worn once a week. The brand product is approved in the U.S. for moderate to severe vasomotor symptoms, such as hot flashes, and for preventing postmenopausal osteoporosis. The generic is approved for women with an intact uterus. The progestogen is included to lower the risk of endometrial hyperplasia, a thickening of the uterine lining.

The strategic logic is simple. A therapeutic equivalent can compete with the brand on price while offering the same dosing. Nanette Santoro, MD, of the University of Colorado School of Medicine, told Healio that generics are usually less expensive than brand products. She said this could make the patch more widely available. That is her expectation, not a finding. The source gives no price, launch date or sales forecast, so the size of any savings is unknown.

The product also combines two drugs in one weekly patch. Santoro said this means one preparation handles both symptom control and uterine protection, and a patient only has to remember one change per week. She also said transdermal estradiol bypasses the liver and is believed to minimize the risk of blood clots, a rare but serious risk of hormone therapy. Santoro reports advising Bayer, among other companies.

One detail in the Healio text is inconsistent. The product description lists levonorgestrel, while Santoro's comment names medroxyprogesterone acetate. This article follows the product description.

The FDA's list of who should not use the patch is long. It includes undiagnosed abnormal genital bleeding, a history of breast cancer, estrogen-dependent neoplasia, active or past deep vein thrombosis or pulmonary embolism, arterial thromboembolic disease, liver disease, and clotting disorders such as protein C, protein S or antithrombin deficiency. Common adverse events include application site reactions, vaginal bleeding, breast pain and headache. A generic does not change that safety profile.

Michael Davis, MD, PhD, director of the FDA's Center for Drug Evaluation and Research, said a patch "offers a convenient alternative to daily oral medications, which may help patients stay on track with their treatment."

This is a regulatory approval based on equivalence to an existing product. It is not new trial evidence about how well the therapy works. What to watch next: when Zydus launches the patch, how it is priced against Climara Pro, whether insurers favor it, and whether other generic makers follow.