NDAINTRAUTERINESYSTEM1 Generic Approved
Approved
Dec 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
MIRENA (levonorgestrel) by Bayer. Approved for progestin [epc]. First approved in 2000.
Drug data last refreshed 14h ago · AI intelligence enriched 20h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MIRENA is a levonorgestrel-releasing intrauterine system (IUS) approved in 2000 for contraception and menorrhagia management. It delivers progestin directly to the uterus via a small T-shaped device, providing long-acting reversible contraception. The mechanism relies on local and systemic progestin activity to prevent pregnancy and reduce menstrual bleeding.
$0.777MPart D
LOE ApproachingDeclining
2.9 years to LOEMIRENA is approaching loss of exclusivity with <3 years of patent protection remaining; commercial teams should expect headcount stabilization or reduction as generic erosion accelerates.
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
27 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.