NDATRANSDERMALSYSTEM3 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 1h ago · AI intelligence enriched 1h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VIVELLE-DOT is a transdermal estradiol patch system approved in 1996 for hormone replacement therapy in menopausal women. It delivers estrogen through the skin to alleviate vasomotor symptoms, vaginal atrophy, and prevent osteoporosis. The drug works as an estrogen receptor agonist, mimicking endogenous estrogen signaling.
$0.004BPart D
LOE ApproachingDeclining
With LOE approaching and moderate market saturation ($4M spending), the brand team is likely consolidating to maximize remaining exclusivity rather than expanding headcount.
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)
Cyclic vs. Constant Estradiol: Regimens' Effects on Brain Health
Started Jul 2026
40 enrolled
MenopauseHealthy AdultBrain+1 more
Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel)
Started Jun 2026
27 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
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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.