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.

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

See drug prices for amifostine

Recent Clinical Trials for amifostine

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

Sponsor	Phase
Institut du Cancer de Montpellier - Val d'Aurelle	Phase 3
Tata Memorial Centre	Phase 3
British Columbia Cancer Agency	Phase 2/Phase 3

See all amifostine clinical trials

Medical Subject Heading (MeSH) Categories for amifostine

Radiation-Protective Agents

Anatomical Therapeutic Chemical (ATC) Classes for amifostine

V03AF	Detoxifying agents for antineoplastic treatment
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

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

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Glossary

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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
>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

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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