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Last Updated: August 11, 2020

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Dexrazoxane hydrochloride - Generic Drug Details

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

Dexrazoxane hydrochloride is the generic ingredient in three branded drugs marketed by Gland Pharma Ltd, Mylan Institutional, West-ward Pharms Int, Clinigen, and Pharmacia And Upjohn, and is included in five NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Dexrazoxane hydrochloride has twenty-two patent family members in sixteen countries.

There are six drug master file entries for dexrazoxane hydrochloride. Seven suppliers are listed for this compound.

Summary for dexrazoxane hydrochloride
Recent Clinical Trials for dexrazoxane hydrochloride

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

SponsorPhase
Hui-Ming ChangPhase 4
IKF Klinische Krebsforschung GmbH at Krankenhaus NordwestPhase 2
St. Jude Children's Research HospitalPhase 1

See all dexrazoxane hydrochloride clinical trials

Pharmacology for dexrazoxane hydrochloride
Medical Subject Heading (MeSH) Categories for dexrazoxane hydrochloride
Paragraph IV (Patent) Challenges for DEXRAZOXANE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
ZINECARD INJECTABLE;INJECTION dexrazoxane hydrochloride 020212

US Patents and Regulatory Information for dexrazoxane hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia And Upjohn ZINECARD dexrazoxane hydrochloride INJECTABLE;INJECTION 020212-002 May 26, 1995 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
West-ward Pharms Int DEXRAZOXANE HYDROCHLORIDE dexrazoxane hydrochloride INJECTABLE;INJECTION 076068-001 Sep 28, 2004 AP RX No No   Start Trial   Start Trial   Start Trial
Clinigen TOTECT dexrazoxane hydrochloride INJECTABLE;INJECTION 022025-001 Sep 6, 2007 RX Yes Yes   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 dexrazoxane hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn ZINECARD dexrazoxane hydrochloride INJECTABLE;INJECTION 020212-002 May 26, 1995   Start Trial   Start Trial
Clinigen TOTECT dexrazoxane hydrochloride INJECTABLE;INJECTION 022025-001 Sep 6, 2007   Start Trial   Start Trial
Pharmacia And Upjohn ZINECARD dexrazoxane hydrochloride INJECTABLE;INJECTION 020212-002 May 26, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
McKesson
Harvard Business School
AstraZeneca
Johnson and Johnson

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