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Last Updated: March 28, 2024

Doxorubicin hydrochloride - Generic Drug Details


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What are the generic drug sources for doxorubicin hydrochloride and what is the scope of freedom to operate?

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

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

Summary for doxorubicin hydrochloride
Recent Clinical Trials for doxorubicin hydrochloride

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

SponsorPhase
Philippe Armand, MD, PhDPhase 2
HighField Biopharmaceuticals CorporationPhase 1
Guangzhou Gloria Biosciences Co., Ltd.Phase 2

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
Mylan Labs Ltd DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 200170-001 Oct 28, 2011 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 064097-001 Sep 13, 1994 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hlthcare DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 200146-001 Jul 18, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 063277-001 Oct 26, 1995 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 062921-001 Mar 17, 1989 RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb RUBEX doxorubicin hydrochloride INJECTABLE;INJECTION 062926-001 Apr 13, 1989 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Baxter Hlthcare Corp DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 212219-002 Oct 19, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Baxter Hlthcare Corp DOXIL (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 050718-001 Nov 17, 1995 ⤷  Try a Trial ⤷  Try a Trial
Baxter Hlthcare Corp DOXIL (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 050718-002 Jun 13, 2000 ⤷  Try a Trial ⤷  Try a Trial
Baxter Hlthcare Corp DOXIL (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 050718-002 Jun 13, 2000 ⤷  Try a Trial ⤷  Try a Trial
>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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