NDAORALTABLET
Approved
Mar 1982
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
3/8 — Basic
SEROPHENE (clomiphene citrate) by Rubicon Biotechnology is clinical pharmacology action clomiphene citrate is a drug of considerable pharmacologic potency. First approved in 1982.
Drug data last refreshed 3h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Serophene (clomiphene citrate) is an oral selective estrogen receptor modulator that induces ovulation in anovulatory women by competitively binding estrogen receptors in the hypothalamus and pituitary, triggering a cascade of gonadotropin release and follicular development. It is a first-line fertility treatment for women with ovulatory dysfunction desiring pregnancy. The drug works through mixed estrogenic and antiestrogenic properties that culminate in a preovulatory gonadotropin surge and follicular rupture.
LOE Approaching
With lifecycle status approaching loss of exclusivity and moderate competitive pressure (30%), brand team focus is shifting toward generic transition planning and retained market share in specialty fertility settings.
Mechanism of Action
CLINICAL PHARMACOLOGY Action Clomiphene citrate is a drug of considerable pharmacologic potency. With careful selection and proper management of the patient, clomiphene citrate has been demonstrated to be a useful therapy for the anovulatory patient desiring pregnancy. Clomiphene citrate is capable…
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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.