NDAINTRAVENOUSSOLUTION
Approved
Dec 2012
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
TOPOTECAN HYDROCHLORIDE (topotecan hydrochloride) by Dr. Reddy's Laboratories. Approved for lung cancer, ovarian cancer, cervical cancer. First approved in 2012.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Topotecan Hydrochloride is a small-molecule topoisomerase I inhibitor approved for intravenous treatment of lung cancer, ovarian cancer, and cervical cancer. It works by stabilizing the topoisomerase I-DNA complex, preventing DNA religation and inducing cell death in rapidly dividing tumor cells. This generic formulation is marketed by Dr. Reddy's Laboratories as a cost-effective alternative to branded versions.
Peak
Product is in peak commercial phase but faces moderate competitive pressure (30 score) from newer immunotherapy and targeted agents, suggesting stable but not expanding team investment.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications (3)
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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.