NDAINTRAVENOUSSOLUTION
Approved
Jul 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
12
Data completeness
4/8 — Partial
INFUGEM (gemcitabine hydrochloride) by Fosun Pharma is g1/s-phase boundary. First approved in 2018.
Drug data last refreshed 12h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INFUGEM is a generic gemcitabine hydrochloride IV solution approved in 2018 by Fosun Pharma. It is a nucleoside analog that works by inhibiting ribonucleotide reductase and incorporating into DNA to trigger apoptosis at the G1/S-phase boundary. It is used across multiple solid tumor indications where gemcitabine is standard-of-care.
Peak7.0 years to LOE
Product is at peak revenue stage with stable market presence, though team size and hiring intensity depend on regional distribution scope and competition dynamics.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (12)
A Clinical Study on the First-line Treatment of Metastatic Pancreatic Cancer With TQB2916 Injection Combined With Gemcitabine Hydrochloride for Injection and Paclitaxel for Injection (Albumin-bound Type)
Started Apr 2025
50 enrolled
Pancreatic Cancer
Nab-paclitaxel and Gemcitabine Hydrochloride Followed by Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
Started Jan 2016
20 enrolled
Pancreatic AdenocarcinomaResectable Pancreatic Carcinoma
Pembrolizumab and Docetaxel or Gemcitabine Hydrochloride in Treating Patients Urothelial Cancer
Started Sep 2015
32 enrolled
Metastatic Urothelial Carcinoma of the Renal Pelvis and UreterRecurrent Bladder CarcinomaRecurrent Urothelial Carcinoma of the Renal Pelvis and Ureter+6 more
Ribociclib and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors or Lymphoma
Started May 2015
10 enrolled
LymphomaSolid Neoplasm
Dovitinib Lactate, Gemcitabine Hydrochloride, and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Solid Tumors or Pancreatic Cancer
Started Mar 2015
0Duct Cell Adenocarcinoma of the PancreasRecurrent Pancreatic CancerStage III Pancreatic Cancer+2 more
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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.