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Last Updated: November 2, 2024

AMIFOSTINE - Generic Drug Details


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What are the generic sources for amifostine and what is the scope of patent protection?

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.

Summary for AMIFOSTINE
US Patents:0
Tradenames:2
Applicants:3
NDAs:3
Drug Master File Entries: 6
Raw Ingredient (Bulk) Api Vendors: 98
Clinical Trials: 86
Patent Applications: 7,290
Drug Prices: Drug price trends for AMIFOSTINE
What excipients (inactive ingredients) are in AMIFOSTINE?AMIFOSTINE excipients list
DailyMed Link:AMIFOSTINE at DailyMed
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

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
Sun Pharm AMIFOSTINE amifostine INJECTABLE;INJECTION 077126-001 Mar 14, 2008 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
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
>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 020221-002 Sep 10, 1999 ⤷  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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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