ORTHO TRI-CYCLEN
LOE ApproachingNDAORAL-28TABLET
Approved
Jul 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
2/8 — Basic
Drug data last refreshed 21h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORTHO TRI-CYCLEN is an oral tablet approved in 1992 for treating HIV infection and Hepatitis C. As a small-molecule NDA product, it represents a foundational antiviral therapy in a crowded competitive landscape dominated by newer mechanistic classes.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); brand teams should expect resource reallocation and focus on transition planning rather than growth initiatives.
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.
Clinical Trials (2)
Study to Assess the Effect of BMS-790052 on the Pharmacokinetics of Ortho Tri-Cyclen® in Healthy Female Subjects
Started Oct 2009
47 enrolled
Chronic Hepatitis C
To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)
Started Sep 2008
409 enrolled
Contraception
Career Relevance
ORTHO TRI-CYCLEN offers limited career growth opportunities given its LOE-approaching status and zero linked job openings; roles available are primarily maintenance-oriented (managed markets, generic transition, contracting). Professionals should view assignments here as portfolio stabilization rather than career acceleration.
Brand Manager
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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.