standard dose ARA-C — Competitive Intelligence Brief

standard dose ARA-C (standard dose ARA-C) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nucleoside analog antimetabolite. Area: Oncology.

marketed Nucleoside analog antimetabolite DNA polymerase; ribonucleotide reductase Oncology Small molecule

Target snapshot

standard dose ARA-C (standard dose ARA-C) — National Research Center for Hematology, Russia. ARA-C (cytarabine) is a cytidine analog that inhibits DNA synthesis by being incorporated into DNA and blocking chain elongation, leading to cell death.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
standard dose ARA-C TARGET	standard dose ARA-C	National Research Center for Hematology, Russia	marketed	Nucleoside analog antimetabolite	DNA polymerase; ribonucleotide reductase
Cytosine Arabinoside	Cytosine Arabinoside	University of Rochester	marketed	Nucleoside analog antimetabolite	DNA polymerase; incorporated into DNA
Gemcitabine Injectable Product	Gemcitabine Injectable Product	Henan Cancer Hospital	marketed	Nucleoside analog antimetabolite	Ribonucleotide reductase; DNA incorporation
AraC	AraC	University of California, San Diego	marketed	Nucleoside analog antimetabolite	DNA polymerase; deoxycytidine kinase
Gemcitabine alone	Gemcitabine alone	Intergroupe Francophone de Cancerologie Thoracique	phase 3	Nucleoside analog antimetabolite	Ribonucleotide reductase; DNA polymerase
high dose cytarabine	high dose cytarabine	International Extranodal Lymphoma Study Group (IELSG)	phase 3	Nucleoside analog antimetabolite	DNA synthesis (cytidine analog)
Cytosin-Arabinosid	Cytosin-Arabinosid	University of Ulm	phase 3	Nucleoside analog antimetabolite	DNA polymerase; cytidine metabolism

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