The Priority Review

Approvals

FDA approves first generic of Climara Pro, a once-weekly estradiol and levonorgestrel patch

The FDA approved the first generic of Climara Pro, an estradiol and levonorgestrel transdermal system (0.045 mg per day/0.015 mg) applied once a week. The FDA said the generic is therapeutically equivalent to Climara Pro.

By The Priority Review desk

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The FDA approved the first generic of Climara Pro, an estradiol and levonorgestrel transdermal system (0.045 mg per day/0.015 mg) applied once a week by women with an intact uterus, the agency said in a news release dated October 20, 2026. The FDA said the generic is therapeutically equivalent to Climara Pro. The FDA approved the product of Zydus Pharmaceuticals (USA) Inc.

Why it matters

The FDA said Climara Pro is indicated for use in women with an intact uterus for treatment of moderate to severe vasomotor symptoms due to menopause and for prevention of postmenopausal osteoporosis. Climara Pro and the generic contain estrogen and progestogen in a single patch, which differs from estrogen-only patches commonly used in menopause treatment. The agency said that in the U.S., nine out of 10 prescriptions filled are for generic drugs.

Approval details

The news release is dated October 20, 2026 and says the agency approved the product yesterday. The approval aligns with FDA's Public Health Pillar: Increasing Access to Affordable Medicines & Medical Products, the agency said.

  • product: estradiol and levonorgestrel transdermal system, 0.045 mg per day/0.015 mg
  • dosing: applied once a week
  • reference product: Climara Pro, a registered trademark of Bayer
  • approved for: women with an intact uterus
  • company: Zydus Pharmaceuticals (USA) Inc.

The FDA asked readers to contact the manufacturer for information about the medicine's availability.

Approval and the intact uterus

The FDA said Climara Pro and the generic are specifically approved for women with an intact uterus. The progestogen component is included to reduce the risk of endometrial hyperplasia that can occur with estrogen use alone, the agency said.

What FDA officials said

Acting FDA Commissioner Kyle Diamantas, J.D. said: "Menopause is a universal experience for women, and it can greatly affect a person's quality of life. This approval makes effective treatment more accessible."

Michael Davis, M.D., Ph.D., Director of FDA's Center for Drug Evaluation and Research, said: "Once-weekly dosing can make a real difference in how patients manage their care." Davis also said: "A patch offers a convenient alternative to daily oral medications, which may help patients stay on track with their treatment."

Safety information

The FDA said Climara Pro and the generic are contraindicated in patients with:

  • undiagnosed abnormal genital bleeding
  • breast cancer or a history of breast cancer
  • estrogen-dependent neoplasia
  • active deep vein thrombosis (DVT), pulmonary embolism (PE) or a history of these conditions
  • active arterial thromboembolic disease or a history of these conditions
  • known anaphylactic reaction or angioedema or hypersensitivity to estradiol and levonorgestrel
  • hepatic impairment or disease
  • protein C, protein S, or antithrombin deficiency, or other thrombophilic disorders

The most common adverse reactions, at greater than or equal to 5%, are application site reaction, vaginal bleeding, breast pain, upper respiratory infection, back pain, depression, pain, headache and flu syndrome, the FDA said.

Sources