Is there a generic for Ziconotide acetate?

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

What is the reference-listed drug for Ziconotide acetate?

PRIALT (NDA 021060, ESTEVE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Ziconotide acetate are approved?

Ziconotide acetate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Ziconotide acetate

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

Reference-listed drug:PRIALT · NDA 021060

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
PRIALTRLD×4	ESTEVE	NDA 021060	—	Dec 28, 2004

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.

Ziconotide acetate — frequently asked questions

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

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