NEXPLANON (etonogestrel)
Nexplanon is a progestin used to prevent pregnancy in women of reproductive potential. This long-acting option helps patients by providing contraceptive protection for up to five years. It is used by women who want a reliable method to avoid pregnancy over an extended period.
How NEXPLANON Works
This medication works by suppressing ovulation so that an egg is not released. It also increases the thickness of cervical mucus and alters the lining of the uterus to prevent pregnancy from occurring.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2006-07-17
- Patent Cliff
- 2030
- Revenue
- $787M (FY-2019)
- Routes
- IMPLANTATION
- Dosage Forms
- IMPLANT
NEXPLANON Approval History
What NEXPLANON Treats
1 indicationsNEXPLANON is approved for 1 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Prevention of pregnancy
NEXPLANON Boxed Warning
RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION and REMOVAL Improper insertion of NEXPLANON increases the risk of complications [see Warnings and Precautions (5.1) ] . Proper training prior to first use of NEXPLANON can minimize the risk of improper NEXPLANON insertion [see Warnings and Precautions (5.1) ] . Because of the risk of complications due to improper insertion and removal NEXPLANON is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) cal...
WARNING: RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION and REMOVAL Improper insertion of NEXPLANON increases the risk of complications [see Warnings and Precautions (5.1) ] . Proper training prior to first use of NEXPLANON can minimize the risk of improper NEXPLANON insertion [see Warnings and Precautions (5.1) ] . Because of the risk of complications due to improper insertion and removal NEXPLANON is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the NEXPLANON REMS [see Warnings and Precautions (5.2) ] . WARNING: RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION and REMOVAL Improper insertion of NEXPLANON increases the risk of complications [see Warnings and Precautions (5.1) ] . Proper training prior to first use of NEXPLANON can minimize the risk of improper NEXPLANON insertion [see Warnings and Precautions (5.1) ] . NEXPLANON is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the NEXPLANON REMS [see Warnings and Precautions (5.2) ] .
NEXPLANON Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to NEXPLANON
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00651807 | P05806 304001 | Ph 2 | terminated | A Trial to Investigate the Effectiveness and Safety of Org 3236 (Etonogestrel) Tablets in Men With Urinary Complaints Suggestive of a Benign Enlargement of the Prostate (304001)(P05806) |
| NCT03978598 LACTO-Rod results posted | 19-049 | Ph 4 | completed | Breastfeeding Etonogestrel Implant Study |
| NCT02082652 | PRO14010195 | Ph 4 | completed | A Pharmacokinetic Evaluation of Etonogestrel (ENG) Implant and Antiretroviral Therapy |
| NCT02480647 | 44827415200005404 | Ph 4 | completed | Clinical Trial the Use of Levonorgestrel-releasing Intrauterine System Versus Etonogestrel Implant in Endometriosis |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NEXPLANON FDA Label Details
Indications & Usage
FDA Label (PDF)NEXPLANON is indicated for the treatment of Prevention of pregnancy.
WARNING: RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION and REMOVAL Improper insertion of NEXPLANON increases the risk of complications [see Warnings and Precautions (5.1) ] . Proper training prior to first use of NEXPLANON can minimize the risk of improper NEXPLANON insertion [see Warnings and Pre...
NEXPLANON Patents & Exclusivity
Patents (4 active)
Exclusivity
Pro Intelligence Preview
Deep insights for NEXPLANON
Revenue Insights
- • FY-2019: $787M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 5 active patents
Trial Analysis
- • 4 total trials
- • Stage: Mature
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment