The U.S. Food and Drug Administration approved the first generic version of Climara Pro, a once-weekly hormone therapy patch for women with an intact uterus.
Approval Details
The FDA approved Zydus Pharmaceuticals (USA) Inc.’s Estradiol and Levonorgestrel Transdermal System at a strength of 0.045 milligrams of estradiol per day and 0.015 milligrams of levonorgestrel. The system is therapeutically equivalent to Climara Pro, a registered trademark of Bayer.
Both products combine estrogen and progestogen in one patch. The progestogen component reduces the risk of endometrial hyperplasia associated with estrogen use alone, according to the FDA.
The products are indicated for treating moderate to severe vasomotor symptoms associated with menopause and for preventing postmenopausal osteoporosis.
Access and Safety Information
The approval falls under the FDA’s Public Health Pillar focused on increasing access to affordable medicines and medical products. The agency said nine out of 10 prescriptions filled in the United States are for generic drugs.
Michael Davis said once-weekly use may help patients manage their care. Kyle Diamantas said menopause can affect quality of life and that the approval makes treatment more accessible.
The FDA lists contraindications including undiagnosed abnormal genital bleeding, breast cancer or a history of breast cancer, estrogen-dependent neoplasia, certain blood-clotting conditions, hypersensitivity to estradiol or levonorgestrel, hepatic disease, and specified thrombophilic disorders.
Adverse reactions occurring in at least 5% of participants include application-site reactions, vaginal bleeding, breast pain, upper respiratory infection, back pain, depression, pain, headache, and flu syndrome.
Regulatory Information
The FDA, an agency within the U.S. Department of Health and Human Services, provided related information through its generic-drug resources and the Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. The agency issued the approval information October 20, 2026.