NDAORALTABLET
Approved
May 2021
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
4/8 — Partial
MYFEMBREE (relugolix, estradiol hemihydrate, and norethindrone acetate) by Sumitomo Dainippon Pharma is gonadotropin releasing hormone receptor antagonists [moa]. First approved in 2021.
Drug data last refreshed 27m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MYFEMBREE is an oral, once-daily combination tablet containing relugolix (a GnRH receptor antagonist), estradiol, and norethindrone acetate approved for the management of heavy menstrual bleeding in premenopausal women. The relugolix component suppresses gonadotropin secretion to reduce menstrual flow, while the estradiol and norethindrone acetate provide hormonal add-back therapy to mitigate hypoestrogenic side effects. This is the first and only oral GnRH antagonist approved for this indication in women.
$0.002BPart D
Peak16.2 years to LOEProduct is in peak lifecycle stage with emerging Part D adoption, indicating active field infrastructure and small but growing team investment.
Mechanism of Action
Gonadotropin Releasing Hormone Receptor Antagonists
Pharmacologic Class:
Gonadotropin Releasing Hormone Receptor Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
MYFEMBREE represents a specialized women's health franchise with strong intellectual property protection and peak-stage commercial momentum, offering stable, long-term career opportunities in a niche therapeutic area. Professionals joining this team will focus on market development, payer education, and physician adoption in an established, non-commoditized space.
Brand Manager
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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.