PREMARIN (estrogens, conjugated) · Pfizer
PREMARIN is FDA-approved to treat 6 conditions (same as CONJUGATED ESTROGENS).
Development Insights
Details
- Status
- Prescription
- First Approved
- 1942-05-08
- Revenue
- $97M (Q4-2024) combined: Premarin family
- Routes
- ORAL, INJECTION, TOPICAL, VAGINAL
- Dosage Forms
- TABLET, INJECTABLE, CREAM
PREMARIN Approval History
What PREMARIN Treats
6 indicationsPREMARIN is approved for 6 conditions since its original approval in 1942. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as CONJUGATED ESTROGENS (same active ingredient).
Pfizer's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02860897 | 08-15-39 | Ph 4 | withdrawn | Patient Adherence to Premarin Versus Vagifem Therapy After Female Pelvic Reconstructive Surgery |
| NCT01778985 PET results posted | STU-042011-101 | Ph 4 | completed | Effect of Preoperative Estrogen Treatment on Connective Tissues of the Pelvic Floor |
| NCT00745173 | 3115A1-1135 | Ph 1 | completed | Study Evaluating Premarin and Bazedoxifene Potential Interaction |
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.
PREMARIN FDA Label Details
Indications & Usage
FDA Label (PDF)PREMARIN is FDA-approved to treat 6 conditions — same approved indications as CONJUGATED ESTROGENS.
Pro Intelligence Preview
Deep insights for PREMARIN
Revenue Insights
- • Q4-2024: $97M (combined: Premarin family)
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • 3 total trials
- • Stage: Mature
Competitive Landscape
- • Competitor tracking
- • 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