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Last Updated: November 22, 2024

DAUNORUBICIN HYDROCHLORIDE Drug Patent Profile


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Which patents cover Daunorubicin Hydrochloride, and what generic alternatives are available?

Daunorubicin Hydrochloride is a drug marketed by Fresenius Kabi Usa, Hikma, Hisun Pharm Hangzhou, Meitheal, and Teva Parenteral. and is included in seven NDAs.

The generic ingredient in DAUNORUBICIN HYDROCHLORIDE is daunorubicin hydrochloride. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the daunorubicin hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Daunorubicin Hydrochloride

A generic version of DAUNORUBICIN HYDROCHLORIDE was approved as daunorubicin hydrochloride by HIKMA on January 30th, 1998.

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Summary for DAUNORUBICIN HYDROCHLORIDE
US Patents:0
Applicants:5
NDAs:7
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 68
Clinical Trials: 374
Patent Applications: 5,985
What excipients (inactive ingredients) are in DAUNORUBICIN HYDROCHLORIDE?DAUNORUBICIN HYDROCHLORIDE excipients list
DailyMed Link:DAUNORUBICIN HYDROCHLORIDE at DailyMed
Drug patent expirations by year for DAUNORUBICIN HYDROCHLORIDE
Recent Clinical Trials for DAUNORUBICIN HYDROCHLORIDE

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

SponsorPhase
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Phase 3
Uwe PlatzbeckerPhase 2
Gilead SciencesPhase 2

See all DAUNORUBICIN HYDROCHLORIDE clinical trials

Pharmacology for DAUNORUBICIN HYDROCHLORIDE

US Patents and Regulatory Information for DAUNORUBICIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa DAUNORUBICIN HYDROCHLORIDE daunorubicin hydrochloride INJECTABLE;INJECTION 065034-001 Nov 20, 2001 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Parenteral DAUNORUBICIN HYDROCHLORIDE daunorubicin hydrochloride INJECTABLE;INJECTION 064212-001 Jun 23, 1998 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hisun Pharm Hangzhou DAUNORUBICIN HYDROCHLORIDE daunorubicin hydrochloride INJECTABLE;INJECTION 208759-001 Apr 12, 2019 AP 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

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