Cyclophosphamide (CTX) — Competitive Intelligence Brief

Cyclophosphamide (CTX) (Cyclophosphamide (CTX)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Alkylating agent. Area: Oncology, Immunology.

phase 3 Alkylating agent DNA (non-specific alkylation) Oncology, Immunology Small molecule

Target snapshot

Cyclophosphamide (CTX) (Cyclophosphamide (CTX)) — Asahi Kasei Pharma Corporation. Cyclophosphamide is an alkylating agent that cross-links DNA strands, preventing cell division and triggering apoptosis in rapidly dividing cells.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Cyclophosphamide (CTX) TARGET	Cyclophosphamide (CTX)	Asahi Kasei Pharma Corporation	phase 3	Alkylating agent	DNA (non-specific alkylation)
Paraplatin	Carboplatin	MYLAN SEIYAKU Ltd	marketed	Platinum-containing alkylating agent	DNA	1989-01-01
Cytoxan (Lyophilized)	cyclophosphamide	Baxter	marketed	Alkylating agent	Tumor cell DNA	1959-01-01
Mitomycin C 0.02%	Mitomycin C 0.02%	Shahid Beheshti University of Medical Sciences	marketed	Alkylating agent	DNA
Cyclophosphamide and glucocorticoids	Cyclophosphamide and glucocorticoids	Peking Union Medical College Hospital	marketed	Alkylating agent + corticosteroid combination
Busulfan (BU)	Busulfan (BU)	Nanfang Hospital, Southern Medical University	marketed	Alkylating agent	DNA (non-specific alkylation)
Mitomycin-C sponge	Mitomycin-C sponge	University of California, San Diego	marketed	Alkylating agent	DNA

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)

• 2035-06-26 — Cytoxan (Lyophilized) · 9662342 · Formulation · US
• 2035-07-13 — Cytoxan (Lyophilized) · 10849916 · Formulation · US
• 2035-12-01 — Cytoxan (Lyophilized) · 11382923 · Formulation · US
• 2036-02-15 — Cytoxan (Lyophilized) · 12329767 · Formulation · US
• 2036-02-15 — Cytoxan (Lyophilized) · 10993952 · Formulation · US

Sponsor landscape (Alkylating agent class)

1. Assistance Publique - Hôpitaux de Paris · 2 drugs in this class
2. M.D. Anderson Cancer Center · 2 drugs in this class
3. Nanfang Hospital, Southern Medical University · 2 drugs in this class
4. Asahi Kasei Pharma Corporation · 1 drug in this class
5. Baxter · 1 drug in this class
6. BeBetter Med Inc · 1 drug in this class
7. Astellas Pharma China, Inc. · 1 drug in this class
8. Children's Cancer Group, China · 1 drug in this class
9. Federal Research Institute of Pediatric Hematology, Oncology and Immunology · 1 drug in this class
10. Celyad Oncology SA · 1 drug in this class