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DOXORUBICIN HYDROCHLORIDE

NDA

DOXORUBICIN HYDROCHLORIDE | N050467 | PFIZER INC

4 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

10 trials from ClinicalTrials.gov — 7 recruiting, 1 active, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Combined Treatment of Durvalumab, Bevacizumab, Tremelimumab and Transarterial Chemoembolization (TACE) in Subjects With Hepatocellular Carcinoma or Biliary Tract Carcinoma NCT03937830	Phase 2	Active	National Cancer Institute (NCI)	27	2021-03-10 → 2027-12-31
Combination Immunotherapy Targeting Sarcomas NCT04433221	Phase 1/2	Recruiting	Shenzhen Geno-Immune Medical Institute	20	2026-07-01 → 2029-12-31
Pegylated Liposomal Doxorubicin (PLD) Versus Active Surveillance for Advanced Soft Tissue Sarcoma Patients Who Had Controlled Disease After Standard Anthracycline-based Treatment (MELODY)NCT06981637	Phase 2	Recruiting	National Health Research Institutes, Taiwan	81	2025-12-31 → 2029-07-31
Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma NCT05711615	Phase 1	Recruiting	National Cancer Institute (NCI)	30	2024-02-06 → 2026-11-03
Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis NCT07193862	Early Phase 1	Recruiting	Northwell Health	10	2025-12-10 → 2028-04-15
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas NCT06422806	Phase 3	Recruiting	National Cancer Institute (NCI)	365	2024-09-11 → 2035-06-30
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer NCT06787612	Phase 2	Recruiting	Regeneron Pharmaceuticals	220	2025-05-28 → 2028-10-30
Protective Effects of the Nutritional Supplement Sulforaphane on Doxorubicin-Associated Cardiac Dysfunction NCT03934905	Phase 1/2	Recruiting	Texas Tech University Health Sciences Center	70	2022-06-01 → 2029-06-01
The Potential Cardioprotective Effect of Addition of Atorvastatin in Breast Cancer Patients NCT07668076	Phase 2	Completed	Damanhour University	44	2022-11-15 → 2024-10-20
Prophylaxis of Hematologic Complications With Naderin in First-Line Breast Cancer Chemotherapy NCT07671547	Phase 2/3	Completed	MIPO Clinic	79	2014-01-01 → 2016-12-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain11 active DMFs2 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

PHARMACIA AND UPJOHN CO WHOLLY OWNED SUB PFIZER INCDOXORUBICIN HYDROCHLORIDE

DMF 20981973

MEIJI SEIKA PHARMA CO LTDDOXORUBICIN HYDROCHLORIDE DRUG SUBSTANCE

DMF 132091998

MICROBIOPHARM JAPAN CO LTDDOXORUBICIN HYDROCHLORIDE

DMF 132111998

TAPI NL BVDOXORUBICIN HYDROCHLORIDE

DMF 137261998

ZHEJIANG HISUN PHARMACEUTICAL CO LTDDOXORUBICIN HYDROCHLORIDE USP

DMF 137731998

SYNBIAS PHARMA AGDOXORUBICIN HYDROCHLORIDE

DMF 161782002

STERLING BIOTECH LTDDOXORUBICIN HYDROCHLORIDE(API)

DMF 248582011

ZHEJIANG HISUN PHARMACEUTICAL CO LTDDOXORUBICIN HYDROCHLORIDE USP (FERMENTATION)

DMF 273112013

OLON SPADOXORUBICIN HYDROCHLORIDE

DMF 300352015

DZD (HEZE) PHARMACEUTICAL CO LTDDOXORUBICIN HYDROCHLORIDE

DMF 311532016

INTAS PHARMACEUTICALS LTDDOXORUBICIN HYDROCHLORIDE USP

DMF 345452020

CHEMWERTH INCInactiveDOXORUBICIN HYDROCHLORIDE USP (NON-STERILE, BULK DRUG SUBSTANCE)

DMF 184622005

RPG LIFE SCIENCES LTDInactiveDOXORUBICIN HYDROCHLORIDE USP/EP

DMF 241282010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Aug 31, 2020	SUPPL -78	View Letter (PDF)
Dec 26, 2019	SUPPL -76	View Letter (PDF)
Aug 12, 2019	SUPPL -77	View Letter (PDF)
Nov 6, 2013	SUPPL -73	View Letter (PDF)
Sep 29, 2011	SUPPL -71	View Letter (PDF)
Aug 9, 2010	SUPPL -70	View Letter (PDF)
May 30, 2003	SUPPL -69	View Letter (PDF)
May 30, 2003	SUPPL -68	View Letter (PDF)
Sep 25, 2002	SUPPL -67	View Letter (PDF)
Sep 25, 2002	SUPPL -64	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 10MG/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 50MG/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#003 — 20MG/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 20, 1985

#004 — 150MG/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jul 22, 1987