NDAVAGINALINSERT
Approved
Jun 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
ENDOMETRIN (progesterone) by Ferring Pharmaceuticals. Approved for progesterone [epc]. First approved in 2007.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ENDOMETRIN is a vaginal progesterone insert containing micronized progesterone, a hormone chemically identical to ovarian progesterone. It treats infertility, preterm birth risk, endometrial hyperplasia, and menopausal symptoms by restoring or supplementing progesterone levels. The micronized formulation enhances bioavailability, achieving peak serum concentrations within 1.5–2.3 hours of administration.
$8KPart D
LOE ApproachingDeclining
Approaching loss of exclusivity with minimal Part D utilization signals reduced growth potential and likely smaller brand teams focused on legacy management.
Mechanism of Action
Pharmacologic Class:
Progesterone
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Exogenous Progesterone as Ovulation Trigger
Started Apr 2026
10 enrolled
OvulationOvarian FunctionAssisted Reproductive Treatments+2 more
Comparing the Pharmacokinetics of a Progesterone Ring Versus a Progesterone Vaginal Insert
Started Nov 2025
60 enrolled
Pre Term Birth
Comparison of Two Vaginal Progesterone Forms in Frozen Embryo Transfer
Started Nov 2024
400 enrolled
Frozen Embryo Transfer (FET)InfertilityArtificial Cycle+1 more
PD-1 Inhibitor Combined With Progesterone Treatment in FST for Patients With MMRd Endometrial Cancer
Started Oct 2024
10 enrolled
Endometrial CancerEndometrioid CarcinomaMismatch Repair Deficiency
Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Daily Oral Micronized Progesterone Versus the Etonogestrel Implant.
Started Jul 2024
34 enrolled
Primary Ovarian InsufficiencyHypogonadotropic HypogonadismHormone Replacement Therapy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.