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Last Updated: August 6, 2020

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Amifostine - Generic Drug Details

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What are the generic drug sources for amifostine and what is the scope of freedom to operate?

Amifostine is the generic ingredient in two branded drugs marketed by Mylan Labs Ltd, Sun Pharm, and Clinigen, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for amifostine. One supplier is listed for this compound.

Drug Prices for amifostine

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Recent Clinical Trials for amifostine

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

SponsorPhase
Institut du Cancer de Montpellier - Val d'AurellePhase 3
British Columbia Cancer AgencyPhase 2/Phase 3
Fudan UniversityPhase 2

See all amifostine clinical trials

Pharmacology for amifostine
Medical Subject Heading (MeSH) Categories for amifostine
Paragraph IV (Patent) Challenges for AMIFOSTINE
Tradename Dosage Ingredient NDA Submissiondate
ETHYOL INJECTABLE;INJECTION amifostine 020221 2004-04-16

US Patents and Regulatory Information for amifostine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm AMIFOSTINE amifostine INJECTABLE;INJECTION 077126-001 Mar 14, 2008 AP RX No No   Start Trial   Start Trial   Start Trial
Clinigen ETHYOL amifostine INJECTABLE;INJECTION 020221-002 Sep 10, 1999 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd AMIFOSTINE amifostine INJECTABLE;INJECTION 204363-001 Jul 17, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Clinigen ETHYOL amifostine INJECTABLE;INJECTION 020221-001 Dec 8, 1995 AP 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 amifostine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Clinigen ETHYOL amifostine INJECTABLE;INJECTION 020221-001 Dec 8, 1995   Start Trial   Start Trial
Clinigen ETHYOL amifostine INJECTABLE;INJECTION 020221-002 Sep 10, 1999   Start Trial   Start Trial
Clinigen ETHYOL amifostine INJECTABLE;INJECTION 020221-002 Sep 10, 1999   Start Trial   Start Trial
Clinigen ETHYOL amifostine INJECTABLE;INJECTION 020221-001 Dec 8, 1995   Start Trial   Start Trial
Clinigen ETHYOL amifostine INJECTABLE;INJECTION 020221-002 Sep 10, 1999   Start Trial   Start Trial
Clinigen ETHYOL amifostine INJECTABLE;INJECTION 020221-001 Dec 8, 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:

Colorcon
Boehringer Ingelheim
Medtronic
Dow
Harvard Business School
Mallinckrodt

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