DOXORUBICIN HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for doxorubicin hydrochloride and what is the scope of patent protection?

Doxorubicin hydrochloride is the generic ingredient in five branded drugs marketed by Baxter Hlthcare Corp, Ayana Pharma Ltd, Dr Reddys, Lupin, Sun Pharm, Zydus Lifesciences, Pfizer, Actavis Inc, Almaject, Amneal, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hisun Pharm Hangzhou, Hlthcare, Mylan Labs Ltd, Norvium Bioscience, Pharmachemie Bv, Sagent Pharms, Sun Pharm Inds, Teva Pharms Usa, and Bristol Myers Squibb, and is included in twenty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for doxorubicin hydrochloride. Sixteen suppliers are listed for this compound.

Summary for DOXORUBICIN HYDROCHLORIDE

US Patents:	0
Tradenames:	5
Applicants:	22
NDAs:	28
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	2,140
Patent Applications:	4,896
What excipients (inactive ingredients) are in DOXORUBICIN HYDROCHLORIDE?	DOXORUBICIN HYDROCHLORIDE excipients list
DailyMed Link:	DOXORUBICIN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for DOXORUBICIN HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
CarThera	Phase 2
Mansoura University	Phase 2
Regeneron Pharmaceuticals	Phase 3

See all DOXORUBICIN HYDROCHLORIDE clinical trials

Pharmacology for DOXORUBICIN HYDROCHLORIDE

Drug Class	Anthracycline Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase Inhibitors

Medical Subject Heading (MeSH) Categories for DOXORUBICIN HYDROCHLORIDE

Antibiotics, Antineoplastic
Topoisomerase II Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DOXORUBICIN HYDROCHLORIDE

L01DB	Anthracyclines and related substances
L01D	CYTOTOXIC ANTIBIOTICS AND RELATED SUBSTANCES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for DOXORUBICIN HYDROCHLORIDE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Lifesciences	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	212299-002	Sep 10, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	ADRIAMYCIN PFS	doxorubicin hydrochloride	INJECTABLE;INJECTION	063165-002	Jan 30, 1991		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Norvium Bioscience	DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	INJECTABLE;INJECTION	200901-001	Feb 14, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for DOXORUBICIN HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare Corp	DOXIL (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	050718-002	Jun 13, 2000	⤷ Sign Up	⤷ Sign Up
Baxter Hlthcare Corp	DOXIL (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	050718-001	Nov 17, 1995	⤷ Sign Up	⤷ Sign Up
Baxter Hlthcare Corp	DOXIL (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	050718-002	Jun 13, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for DOXORUBICIN HYDROCHLORIDE

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
YES Pharmaceutical Development Services GmbH	Celdoxome pegylated liposomal	doxorubicin hydrochloride	EMEA/H/C/005330 Celdoxome pegylated liposomal is indicated in adults:as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk.or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen.in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.for treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (< 200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease.Celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).	Authorised	no	no	no	2022-09-15
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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