NDAORALCAPSULE
Approved
Oct 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
4
Data completeness
6/8 — Strong
BIJUVA (estradiol and progesterone) by Mayne Pharma is estrogen receptor agonists [moa]. First approved in 2018.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BIJUVA is an oral capsule combining estradiol and progesterone approved in 2018 for hormone replacement therapy in menopausal women. It works as an estrogen receptor agonist to alleviate vasomotor symptoms and other menopausal manifestations. The product represents a convenient single-capsule approach to combined hormone therapy.
$0.621MPart D
Peak6.1 years to LOEProduct is at peak commercial maturity with modest Part D claims; brand team is likely stable-sized and focused on market maintenance rather than aggressive growth 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 (4)
Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition
Started Apr 2011
3 enrolled
HyperandrogenemiaPolycystic Ovary Syndrome
Effect of Metformin on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone
Started Feb 2009
25 enrolled
Polycystic Ovary SyndromeHyperandrogenism
Effects of Androgen Blockade on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone
Started Sep 2006
4 enrolled
Polycystic Ovary SyndromeHyperandrogenism
Assessment of the Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition
Started Apr 2000
60 enrolled
HyperandrogenemiaPolycystic Ovary Syndrome (PCOS)
Worked on BIJUVA at Mayne Pharma? Share your interview experience or compensation data (+7 days Pro)
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.