NDAORALTABLET
Approved
Aug 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
FEMTRACE (estradiol acetate) by Millicent Pharma is clinical pharmacology combination oral contraceptives act by suppression of gonadotropins. Approved for pregnancy in women. First approved in 2004.
Drug data last refreshed 17h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FEMTRACE is an oral contraceptive tablet containing estradiol acetate combined with a progestin, approved in 2004. It prevents pregnancy by suppressing gonadotropins to inhibit ovulation while also altering cervical mucus and endometrial conditions. The drug is taken daily by women of reproductive age seeking contraception.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), indicating potential team restructuring and shift toward generic defense or portfolio transition.
Mechanism of Action
CLINICAL PHARMACOLOGY Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the…
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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.