NDAINTRAVENOUSSOLUTION
Approved
Aug 2017
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
GEMCITABINE HYDROCHLORIDE (gemcitabine) by Accord Biopharma is g1/s-phase boundary. Approved for pancreatic cancer, bladder cancer, non-small cell lung cancer and 2 more indications. First approved in 2017.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Gemcitabine Hydrochloride is a nucleoside analog cytotoxic chemotherapy agent approved for treating pancreatic, bladder, non-small cell lung, biliary tract, and ovarian cancers. It works by inhibiting ribonucleotide reductase and incorporating into DNA, triggering apoptosis at the G1/S-phase boundary. The drug is administered intravenously as a solution.
Peak
Peak lifecycle suggests stable team size and established market position; growth opportunities may be limited without label expansions.
Mechanism of Action
G1/S-phase boundary. Gemcitabine is metabolized by nucleoside kinases to diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides. Gemcitabine diphosphate inhibits ribonucleotide reductase, an enzyme responsible for catalyzing the reactions that generate deoxynucleoside triphosphates for DNA…
Indications (5)
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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.