Is there a generic for Anidulafungin?

The FDA Orange Book does not currently list an approved generic (ANDA) for Anidulafungin. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Anidulafungin?

ERAXIS (NDA 021632, VICURON HOLDINGS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Anidulafungin are approved?

Anidulafungin is approved in the following dosage form: powder.

FDA Orange Book · active-ingredient family

Anidulafungin

Anidulafungin is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:ERAXIS · NDA 021632

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · powder

Product	Applicant	Application	TE	Approved
ERAXISRLD×2	VICURON HOLDINGS	NDA 021632	—	Feb 17, 2006

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.

Anidulafungin — frequently asked questions

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

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