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Last Updated: November 21, 2024

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

SponsorPhase
CarTheraPhase 2
Mansoura UniversityPhase 2
Regeneron PharmaceuticalsPhase 3

See all DOXORUBICIN HYDROCHLORIDE clinical trials

Pharmacology for DOXORUBICIN HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for DOXORUBICIN HYDROCHLORIDE

US Patents and Regulatory Information for DOXORUBICIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 215178-002 Jul 16, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pharmachemie Bv DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 063097-002 May 21, 1990 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pharmachemie Bv DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 063097-001 May 21, 1990 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lupin DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 215178-001 Jul 16, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 064140-001 Jul 28, 1995 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pharmachemie Bv DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 063097-003 May 21, 1990 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Baxter Hlthcare Corp DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 212219-002 Oct 19, 2022 AB RX 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for DOXORUBICIN HYDROCHLORIDE

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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