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Last Updated: August 12, 2020

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Doxorubicin hydrochloride - Generic Drug Details

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What are the generic drug 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, Dr Reddys Labs Ltd, Sun Pharm, Pharmacia And Upjohn, Actavis Inc, Alvogen Inc, Amneal, Fresenius Kabi Usa, Gland Pharma Ltd, Hisun Pharm Hangzhou, Hlthcare, Mylan Labs Ltd, Pharmachemie Bv, Sagent Pharms, Sun Pharm Inds, Teva Pharms Usa, West-ward Pharms Int, and Bristol Myers Squibb, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for doxorubicin hydrochloride. Fifteen suppliers are listed for this compound.

Recent Clinical Trials for doxorubicin hydrochloride

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

SponsorPhase
Brooklyn ImmunoTherapeutics, LLCPhase 2
Providence Health & ServicesPhase 2
Alice HoPhase 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
Pharmachemie Bv DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 063097-001 May 21, 1990 AP RX No No   Start Trial   Start Trial   Start Trial
Hlthcare DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 200146-001 Jul 18, 2012 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 203263-002 Feb 4, 2013 AB RX No Yes   Start Trial   Start Trial   Start Trial
Baxter Hlthcare Corp DOXIL (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 050718-001 Nov 17, 1995 AB RX Yes No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Baxter Hlthcare Corp DOXIL (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 050718-002 Jun 13, 2000   Start Trial   Start Trial
Baxter Hlthcare Corp DOXIL (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 050718-001 Nov 17, 1995   Start Trial   Start Trial
Baxter Hlthcare Corp DOXIL (LIPOSOMAL) doxorubicin hydrochloride INJECTABLE, LIPOSOMAL;INJECTION 050718-002 Jun 13, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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