NDAVAGINALTABLET2 Generics Approved
Approved
Mar 1999
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
20
Data completeness
5/8 — Partial
VAGIFEM (estradiol) by Novo Nordisk is estrogen receptor agonists [moa]. Approved for estrogen [epc]. First approved in 1999.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VAGIFEM is a vaginal estradiol tablet indicated for menopausal vaginal atrophy and atrophic vaginitis. It works as an estrogen receptor agonist, delivering localized estrogen to vaginal tissue to restore normal epithelial function and relieve symptoms. The product treats a broad range of conditions linked to estrogen deficiency, from genitourinary syndrome to metabolic and cardiovascular complications.
$3MPart D
LOE ApproachingProduct approaching loss of exclusivity with minimal Part D market presence ($3M, 7,961 claims in 2023); team likely consolidating and shifting focus to lifecycle extension or transition planning.
Mechanism of Action
Estrogen Receptor Agonists
Pharmacologic Class:
Estrogen
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel)
Started May 2026
24 enrolled
Healthy Participants
A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together
Started Mar 2026
48 enrolled
Healthy Volunteers
A Phase 1 Study to Assess the Effect of ABBV-722 on Ethinyl Estradiol and Levonorgestrel Drug Levels in Healthy Adult Female Participants
Started Mar 2026
16 enrolled
Healthy Volunteer
Estradiol-mediated Inflammation and Central Sensitization in the Pathophysiology of Endometriosis-associated Pelvic Pain
Started Dec 2025
130 enrolled
EndometriosisPelvic Pain
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Ethinyl Estradiol/Levonorgestrel (EE/LNG)
Started Dec 2025
24 enrolled
Healthy Volunteer Study
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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.