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Last Updated: June 21, 2024

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 Eugia Pharma Speclts, 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

See drug prices for amifostine

Recent Clinical Trials for amifostine

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

SponsorPhase
Institut du Cancer de Montpellier - Val d'AurellePhase 3
Tata Memorial CentrePhase 3
British Columbia Cancer AgencyPhase 2/Phase 3

See all amifostine clinical trials

Pharmacology for amifostine
Medical Subject Heading (MeSH) Categories for amifostine
Paragraph IV (Patent) Challenges for AMIFOSTINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ETHYOL For Injection amifostine 500 mg/vial 020221 1 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
Clinigen ETHYOL amifostine INJECTABLE;INJECTION 020221-002 Sep 10, 1999 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eugia Pharma Speclts AMIFOSTINE amifostine INJECTABLE;INJECTION 204363-001 Jul 17, 2017 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Clinigen ETHYOL amifostine INJECTABLE;INJECTION 020221-001 Dec 8, 1995 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm AMIFOSTINE amifostine INJECTABLE;INJECTION 077126-001 Mar 14, 2008 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

Expired US Patents for amifostine

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.