NDAINTRAUTERINESYSTEM1 Generic Approved
Approved
Dec 2000
Lifecycle
Peak
Competitive Pressure
23/100
Clinical Trials
20
Data completeness
5/8 — Partial
MIRENA (levonorgestrel) by Bayer. Approved for progestin [epc]. First approved in 2000.
Drug data last refreshed 9h ago · AI intelligence enriched Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MIRENA is a levonorgestrel-releasing intrauterine system (IUS) that delivers progestin directly to the uterus for long-acting contraception and menorrhagia treatment. It is a small-molecule progestin device approved in 2000 that provides sustained hormone release over 5 years. The system works by thickening cervical mucus, suppressing endometrial growth, and inhibiting ovulation in some cycles.
$0.777MPart D
LOE ApproachingStable
3.0 years to LOEMIRENA is in peak lifecycle with patent expiry in 3 years; brand teams should prepare for LOE transition with focus on market share defense and managed care strategy.
Mechanism of Action
Pharmacologic Class:
Progestin
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
An Observational Study to Learn How Mirena and Other Progestogen Treatments Are Used for Endometrial Protection in Women 40+ With a Uterus in the United States Receiving Estrogen Therapy, and Their Respective Health Outcomes
Started Aug 2026
456,000 enrolled
Estrogen Therapy
Effects of Copper Versus Levonorgestrel Intrauterine Devices on Mucosal Microbiota and Barrier Function Among Young African Women
Started Jul 2026
120 enrolled
Vaginal Microbial Diversity
Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel)
Started Jun 2026
24 enrolled
Healthy Participants
A Study to Evaluate the Efficacy and Safety of Subcutaneous Levonorgestrel Butanoate for Female Contraception
Started Apr 2026
165 enrolled
Healthy WomenFemale Contraception
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
15 enrolled
Healthy Volunteer
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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.