NDAORALCAPSULE
Approved
May 2020
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
4/8 — Partial
ORIAHNN (COPACKAGED) (elagolix and estradiol and norethisterone) by AbbVie is estradiol/norethindrone acetate (e2/neta), a combination of estrogen and progestin. Approved for heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. First approved in 2020.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORIAHNN is an oral copackaged combination of elagolix (a GnRH receptor antagonist) with estradiol and norethisterone acetate, designed to treat heavy menstrual bleeding associated with uterine fibroids in premenopausal women. Elagolix suppresses luteinizing and follicle-stimulating hormones to reduce ovarian sex hormone production and bleeding, while the add-back estradiol and progestin protect bone density and the endometrium. This triple-component approach addresses both efficacy and tolerability concerns of GnRH antagonist monotherapy.
Peak14.3 years to LOE
Product is in peak commercial phase with established market presence; AbbVie maintains focused commercial infrastructure around this indication.
Mechanism of Action
estradiol/norethindrone acetate (E2/NETA), a combination of estrogen and progestin. Elagolix is a GnRH receptor antagonist that inhibits endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. Administration of elagolix results in dose-dependent suppression of…
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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.