Epirubicin (E) — Competitive Intelligence Brief

Epirubicin (E) (Epirubicin (E)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Anthracycline topoisomerase II inhibitor. Area: Oncology.

marketed Anthracycline topoisomerase II inhibitor Topoisomerase II, DNA Oncology Small molecule

Target snapshot

Epirubicin (E) (Epirubicin (E)) — Eye & ENT Hospital of Fudan University. Epirubicin is a topoisomerase II inhibitor that intercalates into DNA and prevents cancer cell replication and survival.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Epirubicin (E) TARGET	Epirubicin (E)	Eye & ENT Hospital of Fudan University	marketed	Anthracycline topoisomerase II inhibitor	Topoisomerase II, DNA
Cipro	ciprofloxacin	Bayer AG	marketed	Fluoroquinolone antibiotic	DNA topoisomerase II, DNA gyrase subunit A, DNA gyrase subunit A	1987-10-22
Pegylated liposomal doxorubicin hydrochloride	Pegylated liposomal doxorubicin hydrochloride	M.D. Anderson Cancer Center	marketed	Anthracycline chemotherapy (liposomal formulation)	Topoisomerase II, DNA
Doxorubicin (A)	Doxorubicin (A)	Merck Sharp & Dohme LLC	phase 3	Anthracycline topoisomerase II inhibitor	Topoisomerase II, DNA
epirubicin - cyclophosphamide / docetaxel + bevacizumab	epirubicin - cyclophosphamide / docetaxel + bevacizumab	GBG Forschungs GmbH	phase 3	anthracycline antibiotic, alkylating agent, taxane, monoclonal antibody	topoisomerase II, DNA, microtubules, VEGF
Daunorubicin or Idarubicin	Daunorubicin or Idarubicin	Stichting Hemato-Oncologie voor Volwassenen Nederland	phase 3	Anthracycline topoisomerase II inhibitor	Topoisomerase II, DNA
Etoposide, Ifosfamide, Methotrexate	Etoposide, Ifosfamide, Methotrexate	Gustave Roussy, Cancer Campus, Grand Paris	phase 3	Combination chemotherapy (topoisomerase II inhibitor, alkylating agent, antimetabolite)	DNA (topoisomerase II, DNA alkylation, dihydrofolate reductase)

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)

• 2029-04-21 — Cipro · 11369566 · Formulation · US
• 2029-04-21 — Cipro · 9603796 · Compound · US
• 2029-04-21 — Cipro · 9205048 · Method of Use · US
• 2029-12-11 — Cipro · 9233068 · Formulation · US
• 2030-04-27 — Cipro · 8318817 · Method of Use · US
• 2035-07-01 — Cipro · 9220796 · Formulation · US
• 2037-11-12 — Cipro · 11040004 · Method of Use · US
• 2038-11-27 — Cipro · 11246863 · Formulation · US

Sponsor landscape (Anthracycline topoisomerase II inhibitor class)

1. Asan Medical Center · 1 drug in this class
2. Chinese Academy of Medical Sciences · 1 drug in this class
3. Eye & ENT Hospital of Fudan University · 1 drug in this class
4. Merck Sharp & Dohme LLC · 1 drug in this class
5. Stichting Hemato-Oncologie voor Volwassenen Nederland · 1 drug in this class
6. Suzhou Suncadia Biopharmaceuticals Co., Ltd. · 1 drug in this class
7. The First Affiliated Hospital with Nanjing Medical University · 1 drug in this class