NDAINTRAVENOUSSOLUTION
Approved
Jul 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
12
Data completeness
5/8 — Partial
INFUGEM (gemcitabine hydrochloride) by Fosun Pharma is g1/s-phase boundary. Approved for pancreatic cancer, lung cancer. First approved in 2018.
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INFUGEM is a gemcitabine hydrochloride IV solution approved in 2018 for pancreatic and lung cancer. It works by inhibiting ribonucleotide reductase and incorporating into DNA to trigger apoptosis at the G1/S phase boundary. The drug employs a self-potentiating mechanism where metabolite diphosphate enhances triphosphate incorporation, creating a dual-action cytotoxic effect.
Peak7.2 years to LOE
Product is at peak market maturity with 7.2 years until LOE, indicating stable commercial operations but requiring defensive positioning strategies.
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 (2)
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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.