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 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MIRENA is a levonorgestrel-releasing intrauterine system approved in 2000 for contraception and menorrhagia, operating as a long-acting reversible contraceptive (LARC) device. It works through multiple mechanisms including thickening cervical mucus to inhibit sperm passage, reducing sperm mobility and capacitation, and altering the endometrium. The product is indicated for contraception, heavy menstrual bleeding, dysmenorrhea, adenomyosis, and several off-label uses including endometrial hyperplasia and metabolic conditions.
$0.777MPart D
Peak3.4 years to LOEStable mature product with modest Part D penetration; team size likely optimized for maintenance rather than growth initiatives.
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)
Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel)
Started May 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
16 enrolled
Healthy Volunteer
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Ethinyl Estradiol/Levonorgestrel (EE/LNG)
Started Dec 2025
24 enrolled
Healthy Volunteer Study
Mirena for the Treatment of Nonatypical Endometrial Hyperplasia for 6 Months
Started Nov 2025
207 enrolled
Endometrial Hyperplasia
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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.