5Fluorouracil — Competitive Intelligence Brief

5Fluorouracil (5Fluorouracil) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Antimetabolite. Area: Oncology.

marketed Antimetabolite Thymidylate synthase Oncology Small molecule

Target snapshot

5Fluorouracil (5Fluorouracil) — University of Nebraska. 5-Fluorouracil is a pyrimidine analog that inhibits thymidylate synthase and gets incorporated into RNA and DNA, disrupting nucleotide synthesis and causing cancer cell death.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
5Fluorouracil TARGET	5Fluorouracil	University of Nebraska	marketed	Antimetabolite	Thymidylate synthase
Xeloda	capecitabine	Cheplapharm	marketed	Nucleoside Metabolic Inhibitor [EPC]	Thymidylate synthase	1998-01-01
Fudr	FLOXURIDINE		marketed	Antimetabolite [EPC]	Thymidylate synthase	1970-01-01
Folic Acid	FOLIC ACID	Pfizer	marketed	Vitamin C [EPC]	Thymidylate synthase	1946-01-01
Anlotinib plus Pemetrexed	Anlotinib plus Pemetrexed	Henan Provincial People's Hospital	marketed	Multi-target tyrosine kinase inhibitor plus antifolate antimetabolite	VEGFR, FGFR, RET, c-Kit (anlotinib); thymidylate synthase, DHFR, GARFT (pemetrexed)
SOX plus PD-1 inhibitor	SOX plus PD-1 inhibitor	Liaoning Cancer Hospital & Institute	marketed	Chemotherapy + PD-1 inhibitor combination	PD-1 (programmed death receptor 1); S-1 (thymidylate synthase/5-FU metabolism); oxaliplatin (DNA cross-linking)
Trifluridine and Tipiracil	Trifluridine and Tipiracil	Amgen	marketed	Antimetabolite combination; thymidylate synthase inhibitor	Thymidylate synthase; thymidine phosphorylase

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 (Antimetabolite class)

1. Grupo Espanol Multidisciplinario del Cancer Digestivo · 2 drugs in this class
2. NRG Oncology · 2 drugs in this class
3. Bristol-Myers Squibb · 1 drug in this class
4. EMD Serono Research & Development Institute, Inc. · 1 drug in this class
5. GERCOR - Multidisciplinary Oncology Cooperative Group · 1 drug in this class
6. Hoffmann-La Roche · 1 drug in this class
7. Centre Oscar Lambret · 1 drug in this class
8. Iwate Medical University · 1 drug in this class
9. Janssen Research & Development, LLC · 1 drug in this class
10. Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · 1 drug in this class