FDA approves first generic of Climara Pro once-weekly menopause patch

FDA has approved the first generic version of Climara Pro (estradiol and levonorgestrel transdermal system) , a once-weekly hormone therapy patch for women with an intact uterus. The patch is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause and for the prevention of postmenopausal osteoporosis.

The generic is therapeutically equivalent to Climara Pro, offering the same estrogen–progestogen combination and once-weekly dosing as the brand-name product. Unlike estrogen-only hormone therapy patches, the levonorgestrel component is included to reduce the risk of endometrial hyperplasia, which can occur with unopposed estrogen use in women with an intact uterus.

Safety information is consistent with the reference product. The most common adverse reactions, occurring in at least 5% of patients, include application-site reactions, vaginal bleeding, breast pain, upper respiratory infection, back pain, depression, pain, headache, and influenza-like illness. Labeling carries a boxed warning regarding cardiovascular disorders, probable dementia, and breast cancer.

Contraindications include undiagnosed abnormal genital bleeding; breast cancer or a history of breast cancer; estrogen-dependent neoplasia; active or prior deep vein thrombosis, pulmonary embolism, or arterial thromboembolic disease; hepatic impairment; protein C, protein S, or antithrombin deficiency or other thrombophilic disorders; and hypersensitivity to estradiol or levonorgestrel.

The approval introduces generic competition for an established once-weekly therapy, which FDA says can help make treatment more affordable and expand patient access. Actual pricing has not yet been announced.

Source: FDA. (2026 Oct 20). FDA approves once-weekly generic hormone therapy patch for women