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Last Updated: November 2, 2024

RUBEX Drug Patent Profile


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When do Rubex patents expire, and when can generic versions of Rubex launch?

Rubex is a drug marketed by Bristol Myers Squibb and is included in one NDA.

The generic ingredient in RUBEX 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 Rubex

A generic version of RUBEX was approved as doxorubicin hydrochloride by PFIZER on December 23rd, 1987.

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Summary for RUBEX
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 105
Patent Applications: 4,394
DailyMed Link:RUBEX at DailyMed
Drug patent expirations by year for RUBEX

US Patents and Regulatory Information for RUBEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb RUBEX doxorubicin hydrochloride INJECTABLE;INJECTION 062926-001 Apr 13, 1989 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb RUBEX doxorubicin hydrochloride INJECTABLE;INJECTION 062926-002 Apr 13, 1989 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb RUBEX doxorubicin hydrochloride INJECTABLE;INJECTION 062926-003 Apr 13, 1989 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

EU/EMA Drug Approvals for RUBEX

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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