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Last Updated: November 2, 2024

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) Drug Patent Profile


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When do Doxorubicin Hydrochloride (liposomal) patents expire, and what generic alternatives are available?

Doxorubicin Hydrochloride (liposomal) is a drug marketed by Ayana Pharma Ltd, Baxter Hlthcare Corp, Dr Reddys, Fordoz, Sun Pharm, and Zydus Lifesciences. and is included in six NDAs.

The generic ingredient in DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) is doxorubicin hydrochloride. There are seventeen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Doxorubicin Hydrochloride (liposomal)

A generic version of DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) was approved as doxorubicin hydrochloride by PFIZER on December 23rd, 1987.

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Drug patent expirations by year for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
Recent Clinical Trials for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

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

SponsorPhase
CarTheraPhase 2
Agenus Inc.Phase 2
Yonsei UniversityPhase 2

See all DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) clinical trials

Pharmacology for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

US Patents and Regulatory Information for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ayana Pharma Ltd DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 207228-001 Oct 12, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fordoz DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 215178-001 Jul 16, 2024 AB RX 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

EU/EMA Drug Approvals for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

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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