NDATRANSDERMALFILM, EXTENDED RELEASE
Approved
Nov 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
11
Data completeness
6/8 — Strong
CLIMARA PRO (estradiol and levonorgestrel) by Bayer is estrogen receptor agonists [moa]. Approved for estrogen [epc]. First approved in 2003.
Drug data last refreshed 8m ago · AI intelligence enriched 8m ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CLIMARA PRO is a transdermal extended-release film combining estradiol and levonorgestrel for hormone replacement therapy in menopausal women. It works as an estrogen receptor agonist to alleviate vasomotor symptoms and other menopausal manifestations. The dual-hormone formulation provides both estrogen replacement and progestin protection in a single patch.
$4MPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Part D spending ($4M in 2023), suggesting a contracting team focused on lifecycle management and transition planning.
Mechanism of Action
Estrogen Receptor Agonists
Pharmacologic Class:
Estrogen
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (11)
A Phase 1 Study to Assess the Effect of ABBV-722 on Ethinyl Estradiol and Levonorgestrel Drug Levels in Healthy Adult Female Participants
Started Mar 2026
16 enrolled
Healthy Volunteer
A Study to Investigate the Impact of Multiple Doses of Itraconazole on AZD5004 in Healthy Participants and Multiple Doses of AZD5004 on Combined Oral Ethinyl Oestradiol and Levonorgestrel in Healthy Female Participants
Started May 2025
51 enrolled
Healthy Participants
A Study to Investigate the Pharmacokinetics of Ethinyl Estradiol and Levonorgestrel When Given Alone and in Combination With Baxdrostat in Healthy Females of Non-childbearing Potential
Started Nov 2024
22 enrolled
Healthy Participants
A Study to Assess the Effect of Venetoclax on Ethinyl Estradiol and Levonorgestrel in Female Participants With Different Hematological Malignancies
Started Jul 2019
12 enrolled
Hematologic Malignancies
A Study to Evaluate the Effect of Multiple Oral Doses of JNJ-42847922 on the Steady-state Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel in Healthy Female Adult Participants
Started Aug 2017
24 enrolled
Healthy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.