NDAORAL-21TABLETPriority Review
Approved
May 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
1/8 — Limited
Priority Review
Drug data last refreshed 21h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORTHO TRI-CYCLEN 21 is a combination oral contraceptive containing ethinyl estradiol and norgestimate in a 21-day tablet regimen. It prevents pregnancy through suppression of ovulation and alteration of cervical mucus and endometrium. This product is a mature, well-established hormonal contraceptive used by millions of women globally.
LOE Approaching
As an approaching LOE product, ORTHO TRI-CYCLEN 21 faces declining market exclusivity and margin pressure, signaling potential consolidation or transition of the brand team to line extensions or next-generation formulations.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on ORTHO TRI-CYCLEN 21 offers limited growth trajectory due to LOE approaching and minimal clinical pipeline activity. Career opportunities center on defensive brand management, generic competition mitigation, and customer access strategies rather than innovation or market expansion.
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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.