High Dose Melphalan — Competitive Intelligence Brief

High Dose Melphalan (High Dose Melphalan) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Alkylating agent. Area: Oncology.

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

Target snapshot

High Dose Melphalan (High Dose Melphalan) — M.D. Anderson Cancer Center. High-dose melphalan is an alkylating agent that crosslinks DNA strands, causing cell death, and is used in high doses followed by stem cell rescue to treat hematologic malignancies.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
High Dose Melphalan TARGET	High Dose Melphalan	M.D. Anderson Cancer Center	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
Cyclophosphamide (C)	Cyclophosphamide (C)	Second Affiliated Hospital, School of Medicine, Zhejiang University	marketed	Alkylating agent	DNA
Trabectidin (Yondelis)	Trabectidin (Yondelis)	North Eastern German Society of Gynaecological Oncology	marketed	DNA-binding alkylating agent	DNA (minor groove binder)
prednisone and cyclophosphamide	prednisone and cyclophosphamide	Guangdong Provincial People's Hospital	marketed	Corticosteroid + Alkylating agent combination
Cyclophosphamide (CYC)	Cyclophosphamide (CYC)	Hansa Biopharma AB	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