NDAORALTABLET
Approved
Nov 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
5/8 — Partial
ACTIVELLA (estradiol/norethindrone acetate) by Amneal Pharms is estrogen receptor agonists [moa]. First approved in 1998.
Drug data last refreshed 13h ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ACTIVELLA is an oral hormone replacement therapy combining estradiol and norethindrone acetate, indicated for menopausal symptoms in women. It works by agonizing estrogen receptors to alleviate vasomotor and genitourinary symptoms associated with menopause. The product represents a standard-of-care combined estrogen-progestin approach to HRT.
$0.125MPart D
LOE ApproachingApproaching loss of exclusivity with modest Part D utilization signals a contracting franchise requiring defensive positioning and potential cost optimization initiatives.
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 (5)
Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Started Sep 2017
478 enrolled
Heavy Menstrual BleedingUterine Fibroids
Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)
Started Feb 2016
378 enrolled
Uterine FibroidsHeavy Menstrual Bleeding
Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Started Dec 2015
413 enrolled
Uterine FibroidsHeavy Menstrual Bleeding
Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fasting Conditions
Started Feb 2007
36 enrolled
Healthy
Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fed Conditions
Started Jan 2007
40 enrolled
Healthy
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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.