LO LOESTRIN FE (ethinyl estradiol) · APIL
Lo Loestrin Fe is a combination hormonal medication used by women to prevent pregnancy. It combines a progestin called norethindrone acetate with an estrogen called ethinyl estradiol to provide contraceptive protection. This medication helps women manage their reproductive health, though its effectiveness has not been evaluated in patients with a body mass index greater than 35.
How LO LOESTRIN FE Works
This medication works primarily by suppressing ovulation. By using a combination of hormones to prevent the release of an egg from the ovaries, the drug effectively stops pregnancy from occurring.
Details
- Status
- Prescription
- First Approved
- 2010-10-21
- Patent Cliff
- 2029
- Routes
- ORAL
- Dosage Forms
- TABLET
LO LOESTRIN FE Approval History
What LO LOESTRIN FE Treats
1 indicationsLO LOESTRIN FE is approved for 1 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
LO LOESTRIN FE Boxed Warning
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC ) use. This risk increases with age , particularly in women over 35 years of age , and with the number of cigarettes smoked . For this reason, COCs should not be used by w omen who are over 35 years of age and smoke [ see Contraindications (4) ] . WARNING : CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See Full Prescribing Inform...
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC ) use. This risk increases with age , particularly in women over 35 years of age , and with the number of cigarettes smoked . For this reason, COCs should not be used by w omen who are over 35 years of age and smoke [ see Contraindications (4) ] . 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 Lo Loestrin Fe ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC ) use ( 4 )
LO LOESTRIN FE 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 LO LOESTRIN FE
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 | 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.
LO LOESTRIN FE FDA Label Details
Indications & Usage
FDA Label (PDF)Lo Loestrin ® Fe is indicated for use by women to prevent pregnancy [ see Clinical Studies ] . The efficacy of Lo Loestrin Fe in women with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated. Lo Loestrin Fe is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by women to prevent pregnancy The efficacy of Lo Loestrin Fe in women with a body mass index of > 35 kg/m 2 has not been evaluated
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC ) use. This risk increases with age , particularly in women over 35 years of age , and with the number of cigarettes smoked . Fo...
LO LOESTRIN FE Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for LO LOESTRIN FE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • 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.