Fludarabine Injection — Competitive Intelligence Brief

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

phase 3 Purine analog antimetabolite Ribonucleotide reductase, DNA polymerase Oncology Small molecule

Target snapshot

Fludarabine Injection (Fludarabine Injection) — University of California, San Francisco. Fludarabine is a purine analog that inhibits ribonucleotide reductase and DNA polymerase, leading to disruption of DNA synthesis and cell death in rapidly dividing cells.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Fludarabine Injection TARGET	Fludarabine Injection	University of California, San Francisco	phase 3	Purine analog antimetabolite	Ribonucleotide reductase, DNA polymerase
Fludarabine (Bayer)	Fludarabine (Bayer)	Chinese PLA General Hospital	marketed	Purine analog antimetabolite	Ribonucleotide reductase, DNA polymerase
Fludarabine (FLU)	Fludarabine (FLU)	Nanfang Hospital, Southern Medical University	marketed	Purine nucleoside analog	Ribonucleotide reductase, DNA polymerase
Fludarabine (Flud)	Fludarabine (Flud)	Technische Universität Dresden	marketed	Purine analog antimetabolite	Ribonucleotide reductase, DNA polymerase
Experimental (fludarabine)	Experimental (fludarabine)	French Innovative Leukemia Organisation	phase 3	Purine analog antimetabolite	Ribonucleotide reductase, DNA polymerase
Chemotherapy（pemetrexed/gemcitabine）	Chemotherapy（pemetrexed/gemcitabine）	Shanghai Pulmonary Hospital, Shanghai, China	phase 3	Antimetabolite chemotherapy combination	Thymidylate synthase, dihydrofolate reductase (pemetrexed); ribonucleotide reductase, DNA polymerase (gemcitabine)
Gemcitabine + S-1	Gemcitabine + S-1	AstraZeneca	phase 3	Cytotoxic chemotherapy combination	Ribonucleotide reductase, DNA polymerase, thymidylate synthase

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 (Purine analog antimetabolite class)

1. Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · 1 drug in this class
2. Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · 1 drug in this class
3. Chinese PLA General Hospital · 1 drug in this class
4. French Innovative Leukemia Organisation · 1 drug in this class
5. German CLL Study Group · 1 drug in this class
6. National Cancer Institute (NCI) · 1 drug in this class
7. South China Children's Leukemia Group · 1 drug in this class
8. Technische Universität Dresden · 1 drug in this class
9. University of California, San Francisco · 1 drug in this class