Is there a generic for Pentostatin?

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

What is the reference-listed drug for Pentostatin?

NIPENT (NDA 020122, HOSPIRA INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Pentostatin are approved?

Pentostatin is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Pentostatin

Pentostatin 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:NIPENT · NDA 020122

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
NIPENTRLD	HOSPIRA INC	NDA 020122	AP	Oct 11, 1991

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
PENTOSTATIN	RISING	ANDA 203554	—	Sep 19, 2014
PENTOSTATIN	WEST-WARD PHARMS INT	ANDA 077841	AP	Aug 07, 2007

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.

Pentostatin — frequently asked questions

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

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