Who are 5-Fluouracil's main competitors?

Direct comparators (same drug class / molecular target / therapeutic area): Fluorouracil 0.5%, 5-Fluorouracile, 5-fluoro-uracil, Mycophenolate, Cellcept, Leustatin.

How often does this brief refresh?

Every 30 minutes from primary sources (FDA, EMA, MHRA, PMDA, ClinicalTrials.gov, USPTO). Subscribe to the RSS feed below for push alerts.

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Last reviewed 2026-05-13 · How we verify

5-Fluouracil — Competitive Intelligence Brief

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

marketed Antimetabolite Thymidylate synthase; RNA and DNA incorporation Oncology Small molecule Live · refreshed every 30 min

Target snapshot

5-Fluouracil (5-Fluouracil) — Hoffmann-La Roche. 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)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
5-Fluouracil TARGET	5-Fluouracil	Hoffmann-La Roche	marketed	Antimetabolite	Thymidylate synthase; RNA and DNA incorporation
Fluorouracil 0.5%	Fluorouracil 0.5%	Wake Forest University	marketed	Antimetabolite, pyrimidine analog	Thymidylate synthase; RNA and DNA incorporation
5-Fluorouracile	5-Fluorouracile	Groupe Oncologie Radiotherapie Tete et Cou	marketed	Antimetabolite; pyrimidine analog	Thymidylate synthase; RNA and DNA incorporation
5-fluoro-uracil	5-fluoro-uracil	UNICANCER	marketed	Antimetabolite	Thymidylate synthase; RNA and DNA incorporation
Mycophenolate	MYCOPHENOLIC ACID	Novartis	marketed	Antimetabolite Immunosuppressant	Inosine-5'-monophosphate dehydrogenase 2	2004-01-01
Cellcept	MYCOPHENOLATE MOFETIL	Roche Palo	marketed	Antimetabolite Immunosuppressant	Inosine-5'-monophosphate dehydrogenase 2	1995-01-01
Leustatin	CLADRIBINE		marketed	Purine Antimetabolite [EPC]	cAMP-specific 3',5'-cyclic phosphodiesterase 4A	1993-01-01

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)

2038-11-23 — Leustatin · 10849919 · Method of Use · US
2039-08-16 — Cellcept · 12097284 · Formulation · US
2039-08-16 — Cellcept · 12226526 · Formulation · US
2039-08-16 — Cellcept · 11931455 · Formulation · US
2039-08-16 — Cellcept · 12194143 · Formulation · US
2039-08-16 — Cellcept · 12097285 · Formulation · US
2041-09-10 — Leustatin · 12539329 · Method of Use · US
2041-09-10 — Leustatin · 12533408 · Method of Use · US

Sponsor landscape (Antimetabolite class)

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

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Cite this brief

Drug Landscape (2026). 5-Fluouracil — Competitive Intelligence Brief. https://druglandscape.com/ci/5-fluouracil. Accessed 2026-05-13.

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