Gemcitabine alone — Competitive Intelligence Brief

Gemcitabine alone (Gemcitabine alone) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nucleoside analog antimetabolite. Area: Oncology.

phase 3 Nucleoside analog antimetabolite Ribonucleotide reductase; DNA polymerase Oncology Small molecule

Target snapshot

Gemcitabine alone (Gemcitabine alone) — Intergroupe Francophone de Cancerologie Thoracique. Gemcitabine is a nucleoside analog that inhibits ribonucleotide reductase and gets incorporated into DNA, causing chain termination and cell death.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Gemcitabine alone TARGET	Gemcitabine alone	Intergroupe Francophone de Cancerologie Thoracique	phase 3	Nucleoside analog antimetabolite	Ribonucleotide reductase; DNA polymerase
Gemcitabine (GEM)	Gemcitabine (GEM)	Sun Yat-sen University	marketed	Nucleoside analog; antimetabolite	Ribonucleotide reductase; DNA polymerase
Fludarabine mono	Fludarabine mono	German CLL Study Group	phase 3	Purine analog antimetabolite	Ribonucleotide reductase; DNA polymerase
Chemotherapy, gemcitabine	Chemotherapy, gemcitabine	University of Erlangen-Nürnberg Medical School	phase 3	Nucleoside analog; antimetabolite chemotherapy	Ribonucleotide reductase; DNA polymerase
clofarabine, fludarabine and busulfan, CloFluBu	clofarabine, fludarabine and busulfan, CloFluBu	Vastra Gotaland Region	phase 3	Chemotherapy combination (nucleoside analogs + alkylating agent)	DNA synthesis and repair pathways; ribonucleotide reductase; DNA polymerase
Chemotherapy,Gemcitabine based regimen	Chemotherapy,Gemcitabine based regimen	Eye & ENT Hospital of Fudan University	phase 3	Nucleoside analog; antimetabolite chemotherapy	Ribonucleotide reductase; DNA polymerase
Cytosine Arabinoside	Cytosine Arabinoside	University of Rochester	marketed	Nucleoside analog antimetabolite	DNA polymerase; incorporated into DNA

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Nucleoside analog antimetabolite class)

1. Henan Cancer Hospital · 1 drug in this class
2. Intergroupe Francophone de Cancerologie Thoracique · 1 drug in this class
3. International Extranodal Lymphoma Study Group (IELSG) · 1 drug in this class
4. National Research Center for Hematology, Russia · 1 drug in this class
5. University of California, San Diego · 1 drug in this class
6. University of Rochester · 1 drug in this class
7. University of Ulm · 1 drug in this class