Is there a generic for Ioflupane i-123?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Ioflupane i-123, referencing the brand DATSCAN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ioflupane i-123?

DATSCAN (NDA 022454, GE HLTHCARE INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Ioflupane i-123 are approved?

Ioflupane i-123 is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Ioflupane i-123

Ioflupane i-123 is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DATSCAN · NDA 022454

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution

Product	Applicant	Application	TE	Approved
DATSCANRLD	GE HLTHCARE INC	NDA 022454	AP	Jan 14, 2011

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
IOFLUPANE I-123	CURIUM	ANDA 213792	AP	Mar 30, 2022

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.

Ioflupane i-123 — frequently asked questions

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

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