Wednesday, July 8, 2026

Drug profile · INN

gemcitabine

gemcitabine (DBL GEMCITABINE INJECTION) is a dna polymerase (alpha/delta/epsilon) inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

FDA: approved TGA: approved NMPA: clinical trials
US status approved
Patents linked 20
Pipeline programs 137
News articles 0
Congress events 1
Drug details — gemcitabine
US status
approved
Class
Route
INJECTION
Patents
20
Programs
137
Data quality
0.89

Quick answer

gemcitabine (DBL GEMCITABINE INJECTION) is a dna polymerase (alpha/delta/epsilon) inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN gemcitabine
Brand DBL GEMCITABINE INJECTION
Mechanism DNA polymerase (alpha/delta/epsilon) inhibitor
Route INJECTION
Formulation INJECTABLE

Mechanism of action

DNA polymerase (alpha/delta/epsilon) inhibitor

Approval history

Authority Status Date
FDA approved
TGA approved
NMPA clinical trials

Congress & event coverage

  • Presentation
    ScopeX

    1 presentation · general

Pipeline programs

  1. 000434 Phase 3 · Ferring Pharmaceuticals · High-risk Bacillus Calmette-Guerin (BCG)-unresponsive non-mu
  2. 17000139BLC3001 Phase 3 · Janssen-Cilag International N.V · Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder
  3. 17000139BLC3004 Phase 3 · Janssen-Cilag International N.V · High-Risk Non-muscle-invasive Bladder Cancer
  4. 2020HXFH037 Phase 3 · Chinese Academy of · Nasopharyngeal Carcinoma
  5. 42756493BLC3004 Phase 3 · Janssen-Cilag International N.V · FGFR+ Intermediate-risk Non-muscle Invasive Bladder Cancer
  6. 42756493BLC3005 Phase 3 · Janssen-Cilag International N.V · High-risk Non-muscle-invasive Bladder Cancer with Susceptibl
  7. AFMMUChina Phase 3 · Chinese Academy of · Nasopharyngeal Carcinoma
  8. ALKS 4230-007 Phase 3 · Createrna Science and · Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Pr
  1. US 12377112

    Methods of treating neurocognitive disorders, chronic pain and reducing inflammation

    Expires Mon Jul 31 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 12338438

    Conjugated oligonucleotide compounds, methods of making and uses thereof

    Expires Mon Jun 19 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 12145943

    Solid forms of 3-(5-Fluorobenzofuran-3-yl)-4-(5-methyl-5H-[1,3]dioxolo[4,5-f]indol-7-yl)pyrrole-2,5-dione

    Expires Mon Nov 14 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 12116374

    Solid forms of 3-(5-Fluorobenzofuran-3-yl)-4-(5-methyl-5H-[1,3]dioxolo[4,5-f]indol-7-yl)pyrrole-2,5-dione

    Expires Mon Oct 10 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 11970538

    Multispecific binding constructs against checkpoint molecules and uses thereof

    Expires Mon Apr 25 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 11865126

    Method for treating anxiety disorders, headache disorders, and eating disorders with psilocybin

    Expires Mon Jan 04 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 11738035

    Method for treating anxiety disorders, headache disorders, and eating disorders with psilocybin

    Expires Mon Aug 24 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 11661617

    Processes for the production of tryptamines

    Expires Mon May 25 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 11564935

    Method for treating anxiety disorders, headache disorders, and eating disorders with psilocybin

    Expires Mon Jan 26 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 11407759

    Solid forms of 3-(5-fluorobenzofuran-3-yl)-4-(5-methyl-5H-[1,3]dioxolo[4,5-f]indol-7-yl)pyrrole-2,5-dione

    Expires Mon Aug 04 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 11136334

    Solid forms of 3-(5-Fluorobenzofuran-3-yl)-4-(5-methyl-5H-[1,3]dioxolo[4,5-f]indol-7-yl)pyrrole-2,5-dione

    Expires Mon Sep 30 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. US 11046769

    Multispecific binding constructs against checkpoint molecules and uses thereof

    Expires Mon Jun 24 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 10973869

    Methods of treating cardiomyopathy associated with genetic disorders

    Expires Mon Apr 08 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. US 10961238

    Modulators of hedgehog (Hh) signaling pathway

    Expires Mon Mar 25 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. US 10532059

    Steroid hormone pharmaceutical composition

    Expires Mon Jan 09 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  16. US 10369098

    Methods for localized drug delivery

    Expires Mon Aug 01 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  17. US 10286077

    Steroid hormone compositions in medium chain oils

    Expires Mon May 09 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  18. US 10098894

    Transdermal cream

    Expires Mon Oct 11 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  19. US 9974853

    Immunoregulatory peptides and methods of use

    Expires Mon May 17 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  20. US 9931349

    Steroid hormone pharmaceutical composition

    Expires Mon Mar 29 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is gemcitabine?

gemcitabine (DBL GEMCITABINE INJECTION) is a dna polymerase (alpha/delta/epsilon) inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for gemcitabine?

DBL GEMCITABINE INJECTION is a marketed brand name for gemcitabine. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of gemcitabine?

gemcitabine has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.