FDA approves first generic of Climara Pro hormone therapy patch

The FDA announced on October 20, 2026 that it had approved the first generic of Climara Pro (estradiol and levonorgestrel transdermal system, 0.045 mg per day/0.015 mg), a transdermal hormone therapy patch for women with an intact uterus applied once a week.¹ The approval was described as supporting FDA's Public Health Pillar: Increasing Access to Affordable Medicines & Medical Products.¹

The agency said the generic product is therapeutically equivalent to Climara Pro, which is indicated for use in women with an intact uterus for treatment of moderate to severe vasomotor symptoms due to menopause and prevention of postmenopausal osteoporosis. Climara Pro and the generic estradiol and levonorgestrel transdermal system contain both estrogen and progestogen in a single patch, unlike estrogen-only patches commonly used in menopause treatment.¹ The FDA noted that both products are approved specifically for women with an intact uterus because the progestogen is added to lower the chance of endometrial hyperplasia that can occur when estrogen is used alone.¹

The FDA listed contraindications including undiagnosed abnormal genital bleeding, breast cancer or a history of it, estrogen-dependent neoplasia, active or prior deep vein thrombosis, pulmonary embolism or arterial thromboembolic disease, known hypersensitivity or anaphylaxis to the drug components, liver impairment or disease, and clotting disorders such as protein C, protein S or antithrombin deficiency.¹ Common side effects seen in at least 5% of patients were reported as application site reaction, vaginal bleeding, breast pain, upper respiratory infection, back pain, depression, general pain, headache and flu-like symptoms.¹

The agency said nine out of 10 U.S. prescriptions filled are for generic drugs, and expanding generic availability helps create market competition that can lower costs and broaden access to treatment.¹ The FDA noted that Climara Pro is a registered trademark of Bayer, while the newly approved generic version was cleared for Zydus Pharmaceuticals (USA) Inc.¹