XULANE (ethinyl estradiol)
Xulane is a combination hormonal contraceptive (transdermal system) containing norelgestromin and ethinyl estradiol, indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m². It is intended for patients for whom combined hormonal contraception is appropriate. Xulane may be less effective in women weighing 198 lbs (90 kg) or more and is contraindicated for use in women with a BMI ≥ 30 kg/m². IMPROVED_MOA
How XULANE Works
This medication works by suppressing gonadotropins, which primarily acts to inhibit ovulation. It also helps prevent pregnancy by thickening cervical mucus to make sperm entry into the uterus more difficult and by altering the lining of the uterus to reduce the likelihood of implantation.
Details
- Status
- Prescription
- First Approved
- 2014-04-16
- Routes
- TRANSDERMAL
- Dosage Forms
- FILM, EXTENDED RELEASE
XULANE Approval History
What XULANE Treats
1 indicationsXULANE is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pregnancy prevention
XULANE Boxed Warning
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥ 30 kg/m 2 • Cigarette Smoking and Serious Cardiovascular Events Cigarette smoking increases the risk of serious cardiovascular events from hormonal contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including Xulane, are contraindicated in women who are over 35 years of age and smoke [see Contraind...
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥ 30 kg/m 2 • Cigarette Smoking and Serious Cardiovascular Events Cigarette smoking increases the risk of serious cardiovascular events from hormonal contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including Xulane, are contraindicated in women who are over 35 years of age and smoke [see Contraindications (4) and Warnings and Precautions (5.1) ] . • Contraindicated in Women with a BMI ≥ 30 kg/m 2 Xulane is contraindicated in women with a BMI ≥ 30 kg/m 2 . The risk of VTE may be greater with Xulane in women with a BMI > 30 kg/m 2 compared to women with a lower BMI. [see Contraindications (4) and Warnings and Precautions (5.1 )] . WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥ 30 kg/m 2 See full prescribing information for complete boxed warning. • Xulane is contraindicated in women over 35 years old who smoke. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. ( 4 , 5.1 ) • Xulane is contraindicated for use in women with a BMI ≥ 30 kg/m 2 . Women with a BMI ≥ 30 kg/m 2 who use Xulane may have a higher risk of venous thromboembolic events compared with women with a lower BMI. ( 4 , 5.1 , 8.8 )
XULANE 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 XULANE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07340190 | CDAK539A12102 2025-521000-22-00 | Ph 1 | not yet recruiting | A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies |
| NCT06039826 | 18533 J1I-MC-GZBV | Ph 1 | completed | A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese |
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.
XULANE FDA Label Details
Indications & Usage
XULANE is indicated for the treatment of Pregnancy prevention.
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥ 30 kg/m 2 • Cigarette Smoking and Serious Cardiovascular Events Cigarette smoking increases the risk of serious cardiovascular events from hormonal contraceptive use. This risk increases with age, ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.