Is there a generic for Amifostine?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Amifostine, referencing the brand ETHYOL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Amifostine?

ETHYOL (NDA 020221, LEGACY PHARMA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Amifostine are approved?

Amifostine is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Amifostine

Amifostine is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ETHYOL · NDA 020221

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
ETHYOLRLD×2	LEGACY PHARMA	NDA 020221	—	Dec 08, 1995

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
AMIFOSTINE	EUGIA PHARMA SPECLTS	ANDA 204363	—	Jul 17, 2017
AMIFOSTINE	SUN PHARM	ANDA 077126	—	Mar 14, 2008

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Amifostine — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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