NDATOPICALEMULSION
Approved
Oct 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
ESTRASORB (estradiol hemihydrate) by Xeltis is relugolix, estradiol (e2), and norethindrone acetate (neta). Approved for heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women [ see clinical studies () ], moderate to severe pain associated with endometriosis in premenopausal women [ see clinical studies () ], premenopausal women for the: management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids). First approved in 2003.
Drug data last refreshed 17h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ESTRASORB is a topical estradiol hemihydrate emulsion approved in 2003 for hormone replacement and menopausal symptom management in women. It delivers bioidentical estradiol transdermally, avoiding first-pass hepatic metabolism and providing stable serum levels. The formulation is designed for women seeking non-systemic or lower-dose estrogen therapy.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100) signals a contracting commercial organization focused on efficiency and market defense rather than expansion.
Mechanism of Action
relugolix, estradiol (E2), and norethindrone acetate (NETA). Relugolix is a non-peptide GnRH receptor antagonist that competitively binds to pituitary GnRH receptors, thereby reducing the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to decreased serum…
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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.