Fludarabine , cytarabine — Competitive Intelligence Brief

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

phase 2 Nucleoside analog Ribonucleotide reductase Oncology Small molecule

Target snapshot

Fludarabine , cytarabine (Fludarabine , cytarabine) — Cooperative Study Group A for Hematology. Fludarabine is a nucleoside analog that inhibits DNA synthesis by interfering with ribonucleotide reductase.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Fludarabine , cytarabine TARGET	Fludarabine , cytarabine	Cooperative Study Group A for Hematology	phase 2	Nucleoside analog	Ribonucleotide reductase
Gemzar	Gemcitabine Hydrochloride	Accord Hlthcare	marketed	Nucleoside metabolic inhibitor	Ribonucleotide reductase; DNA incorporation	1996-01-01
HYDROXYUREA	HYDROXYUREA		marketed	Antimetabolite [EPC]	Ribonucleotide reductase	1967-01-01
Hydrea® (hydroxyurea )	Hydrea® (hydroxyurea )	Assistance Publique - Hôpitaux de Paris	marketed	Antimetabolite; ribonucleotide reductase inhibitor	Ribonucleotide reductase
Gemcitabine-Cisplatin chemotherapy	Gemcitabine-Cisplatin chemotherapy	Simcere Pharmaceutical Co., Ltd	marketed	Chemotherapy combination (nucleoside analog + platinum agent)	DNA (multiple targets including ribonucleotide reductase inhibition and DNA cross-linking)
standard dose ARA-C	standard dose ARA-C	National Research Center for Hematology, Russia	marketed	Nucleoside analog antimetabolite	DNA polymerase; ribonucleotide reductase
Ara-C	Ara-C	M.D. Anderson Cancer Center	marketed	Nucleoside analog, antimetabolite	DNA polymerase, ribonucleotide reductase

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)

• 2030-06-28 — Gemzar · 12403086 · Formulation · US
• 2032-04-15 — Gemzar · 8679094 · Formulation · US
• 2033-07-01 — Gemzar · 9241948 · Formulation · US
• 2034-08-19 — Gemzar · 10729823 · Formulation · US
• 2034-08-19 — Gemzar · 12447241 · Formulation · US
• 2041-12-23 — HYDROXYUREA · 12409156 · Formulation · US

Sponsor landscape (Nucleoside analog class)

1. Third Affiliated Hospital, Sun Yat-Sen University · 2 drugs in this class
2. Actuate Therapeutics Inc. · 2 drugs in this class
3. City of Hope Medical Center · 1 drug in this class
4. Cooperative Study Group A for Hematology · 1 drug in this class
5. Genzyme, a Sanofi Company · 1 drug in this class
6. Hospices Civils de Lyon · 1 drug in this class
7. Innovent Biologics (Suzhou) Co. Ltd. · 1 drug in this class
8. Osaka Medical Center for Cancer and Cardiovascular Diseases · 1 drug in this class
9. Tanabe Pharma Corporation · 1 drug in this class
10. The Methodist Hospital Research Institute · 1 drug in this class