NDAORAL-28TABLETPriority Review
Approved
May 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
1/8 — Limited
Priority Review
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Ortho Tri-Cyclen 28 is an oral combined hormonal contraceptive containing ethinyl estradiol and norgestimate in a triphasic formulation. It prevents ovulation and is indicated for contraception in women of reproductive age. The drug works by suppressing the luteinizing hormone (LH) surge required for ovulation while altering cervical mucus to create a hostile environment for sperm.
LOE Approaching
As an established oral contraceptive approaching loss of exclusivity with moderate competitive pressure (30), teams are likely focused on lifecycle extension, patient retention, and preparing for generic erosion.
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
Ortho Tri-Cyclen 28 offers limited career growth due to its approaching LOE status and saturated market positioning; roles are defensive and focused on generic transition planning and market maintenance. Professionals joining this product team should expect downsizing and redeployment as the brand faces imminent generic competition.
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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.