NDAINTRAUTERINESYSTEM1 Generic Approved
Approved
Sep 2016
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
6/8 — Strong
KYLEENA (levonorgestrel) by Bayer. Approved for progestin [epc]. First approved in 2016.
Drug data last refreshed 1h ago · AI intelligence enriched 1h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KYLEENA is a levonorgestrel-releasing intrauterine system (IUS) approved in 2016 for contraception. It is a small-molecule progestin delivered directly into the uterus over an extended period. The device provides long-acting reversible contraception by releasing the synthetic progestin levonorgestrel locally.
$0.049BPart D
LOE Approaching2.9 years to LOEProduct approaching loss of exclusivity with modest Part D claims; brand team focus is likely shifting to lifecycle extension or managed decline strategies.
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)
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
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Ethinyl Estradiol/Levonorgestrel (EE/LNG)
Started Dec 2025
24 enrolled
Healthy Volunteer Study
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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.