FEMLYV (ethinyl estradiol)
FEMLYV is a combination hormonal medication used for the prevention of pregnancy in females of reproductive potential. It helps patients avoid conception by providing a blend of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen. This contraceptive is used by women who can become pregnant, though its effectiveness has not been evaluated in individuals with a body mass index greater than 35 kg/m².
How FEMLYV Works
This medication works by utilizing combined hormones to lower the risk of becoming pregnant. Its primary action is the suppression of ovulation, which prevents the release of an egg during the reproductive cycle.
Details
- Status
- Prescription
- First Approved
- 2024-07-22
- Patent Cliff
- 2041
- Routes
- ORAL
- Dosage Forms
- TABLET, ORALLY DISINTEGRATING
FEMLYV Approval History
What FEMLYV Treats
1 indicationsFEMLYV is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pregnancy prevention
FEMLYV Boxed Warning
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combined oral contraceptive (COC) use. This risk increases with age, particularly in females over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including FEMLYV, are contraindicated in females who are over 35 years of age and smoke [see Contraindications (4) and Warnings & Precautions (5) ]. WARNING: CIGARETTE SMOKING AND SERIOUS CARDI...
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combined oral contraceptive (COC) use. This risk increases with age, particularly in females over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including FEMLYV, are contraindicated in females who are over 35 years of age and smoke [see Contraindications (4) and Warnings & Precautions (5) ]. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. • Women over 35 years old who smoke should not use FEMLYV ( 4 ) • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use ( 4 )
FEMLYV 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 FEMLYV
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.
FEMLYV FDA Label Details
Indications & Usage
FDA Label (PDF)FEMLYV is indicated for the treatment of Pregnancy prevention.
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combined oral contraceptive (COC) use. This risk increases with age, particularly in females over 35 years of age, and with the number of cigarettes smoked. For thi...
FEMLYV Patents & Exclusivity
Patents (1 active)
Exclusivity
Pro Intelligence Preview
Deep insights for FEMLYV
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 1 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 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.