NDAORALTABLETPriority Review
Approved
Jul 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
PLAN B (levonorgestrel) by Teva is demonstrated. First approved in 1999.
Drug data last refreshed 18h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Plan B (levonorgestrel) is an oral emergency contraceptive tablet approved in 1999 that prevents pregnancy through multiple mechanisms including cervical mucus thickening, sperm immobilization, and endometrial alteration. It is taken as a single dose following unprotected intercourse to prevent fertilization. The drug works as a progestin-based contraceptive available over-the-counter in many markets.
LOE Approaching
As a mature product approaching loss of exclusivity with moderate competitive pressure (30%), the brand team is likely lean and focused on market defense and cost management rather than growth initiatives.
Mechanism of Action
demonstrated. Studies of LNG-releasing IUSs suggest several mechanisms for pregnancy prevention: prevention of fertilization due to the thickening of the cervical mucus, which inhibits sperm passage through the cervix, and inhibition of sperm mobility and function (capacitation), and alteration of…
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
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
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.