Capecitabine-based chemotherapy — Competitive Intelligence Brief

Capecitabine-based chemotherapy (Capecitabine-based chemotherapy) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Fluoropyrimidine antimetabolite. Area: Oncology.

phase 3 Fluoropyrimidine antimetabolite Thymidylate synthase Oncology Small molecule

Target snapshot

Capecitabine-based chemotherapy (Capecitabine-based chemotherapy) — Ain Shams University. Capecitabine is a prodrug that is converted to fluorouracil in tumor tissue, where it inhibits thymidylate synthase and gets incorporated into DNA and RNA to disrupt cancer cell replication.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Capecitabine-based chemotherapy TARGET	Capecitabine-based chemotherapy	Ain Shams University	phase 3	Fluoropyrimidine 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
5-Fluorouracile	5-Fluorouracile	Groupe Oncologie Radiotherapie Tete et Cou	marketed	Antimetabolite; pyrimidine analog	Thymidylate synthase; RNA and DNA incorporation
5-Fluouracil	5-Fluouracil	Hoffmann-La Roche	marketed	Antimetabolite	Thymidylate synthase; RNA and DNA incorporation
XELODA [capecitabine]	XELODA [capecitabine]	Hoffmann-La Roche	marketed	Fluoropyrimidine antimetabolite	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 (Fluoropyrimidine antimetabolite class)

1. Federation Francophone de Cancerologie Digestive · 2 drugs in this class
2. National Cancer Center, Korea · 2 drugs in this class
3. Hoffmann-La Roche · 1 drug in this class
4. Japan Clinical Oncology Group · 1 drug in this class
5. Jiangxi Provincial Cancer Hospital · 1 drug in this class
6. Peter MacCallum Cancer Centre, Australia · 1 drug in this class
7. Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · 1 drug in this class
8. Taiho Pharmaceutical Co., Ltd. · 1 drug in this class
9. The First Affiliated Hospital of Henan University of Science and Technology · 1 drug in this class
10. UNICANCER · 1 drug in this class