NDATRANSDERMALSYSTEM2 Generics Approved
Approved
Jul 1996
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
20
Data completeness
5/8 — Partial
VIVELLE-DOT (estradiol) by Novartis is estrogen receptor agonists [moa]. Approved for estrogen [epc]. First approved in 1996.
Drug data last refreshed 13h ago · AI intelligence enriched 16h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VIVELLE-DOT is a transdermal estradiol patch approved in 1996 for hormone replacement therapy in menopausal women. It delivers estrogen systemically through the skin to alleviate vasomotor symptoms and genitourinary symptoms associated with menopause. The drug works as an estrogen receptor agonist, mimicking the body's natural estrogen signaling.
$0.004BPart D
LOE ApproachingStable
Product is approaching loss of exclusivity with modest Part D spending of $4M across 13,645 claims; commercial teams should prepare for generic erosion and potential organizational consolidation.
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 Jun 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
15 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.