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  1. pharmadog
  2. ›drugs
  3. ›GEMCITABINE HYDROCHLORIDE
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GEMCITABINE HYDROCHLORIDE

Marketedupdated 3mo ago
by $JNJ JOHNSON & JOHNSON🔗 ChEMBL
Approved
community read0 votes

🐶 often sniffed alongside

top 2
  • tagApproval6 co-mentions · 3 sources
  • druggemcitabine3 co-mentions · 3 sources

Small molecule drug with a maximum clinical stage of Approval (across all indications), with 6 approved and 27 investigational indications.

indications

investigational
NSCLCBreast Cancer

targets

DNA polymerase (alpha/delta/epsilon)Ribonucleoside-diphosphate reductase RR1

all catalysts(3)

approval · 3
Jul 20, 2018
approval
8y ago
GEMCITABINE HYDROCHLORIDE — FDA approval
GEMCITABINE HYDROCHLORIDE
→
Nov 4, 2020
approval
6y ago
GEMCITABINE HYDROCHLORIDE — FDA approval
GEMCITABINE HYDROCHLORIDE
→
Mar 13, 2026
approval
5mo ago
GEMCITABINE HYDROCHLORIDE — FDA approval
GEMCITABINE HYDROCHLORIDE
→

Trials studying GEMCITABINE HYDROCHLORIDE

  • phase3A Study of BEBT-209 Plus Chemotherapy in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancerrecruitingn=446
  • phase3Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Canceractive not recruitingn=579
  • phase3A Phase 3 Clinical Study of SHR-A1912 Combined With R-GemOx Versus R-GemOx in Diffuse Large B-cell Lymphomarecruitingn=280
  • phase3Clinical Trial Comparing TQB2868 Injection Combined With Anlotinib Hydrochloride Capsules With Placebo Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)recruitingn=566
  • phase1Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumorsactive not recruitingn=61
  • phase3Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinomaactive not recruitingn=420
  • phase3A Study of SHR-A1811 in Subjects With Ovarian Cancerrecruitingn=300
  • phase3A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who Have Failed Standard of Carerecruitingn=364
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Sep 9, 2028
~2.1 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (15)

  • Aug 19, 2034formulationUS 10729823
  • Aug 19, 2034formulationUS 12447241
  • Jul 1, 2033formulationUS 9241948
  • Jul 1, 2033formulationUS 9241948
  • Jul 1, 2033formulationUS 9241948
  • Jul 1, 2033formulationUS 9241948
  • Jul 1, 2033formulationUS 9241948
  • Jul 1, 2033formulationUS 9241948
  • Jul 1, 2033formulationUS 9241948
  • Jul 1, 2033formulationUS 9241948
  • Jul 1, 2033formulationUS 9241948
  • Jul 1, 2033formulationUS 9241948
  • Apr 15, 2032formulationUS 8679094
  • Dec 17, 2030formulationUS 125762534.3y
  • Jun 28, 2030formulationUS 124030863.9y

FDA exclusivities (1)

  • Sep 9, 2028NPNP2.1y

News(0)

no news has mentioned this drug yet

brand
GEMCITABINE HYDROCHLORIDE
trade names
Gemcitabine hydrochloride, Gemzar, Infugem
generic
GEMCITABINE HYDROCHLORIDE
MOA
DNA polymerase (alpha/delta/epsilon) inhibitor; Ribonucleoside-diphosphate reductase RR1 inhibitor
indication
Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer)
phase
marketed
Data sources
openFDA · ClinicalTrials.gov · OpenTargets
last refreshed 6m ago
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