Is there a generic for Ipodate sodium?

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

What is the reference-listed drug for Ipodate sodium?

ORAGRAFIN SODIUM (NDA 012967, BRACCO) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Ipodate sodium are approved?

Ipodate sodium is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Ipodate sodium

Ipodate sodium 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:ORAGRAFIN SODIUM · NDA 012967

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
ORAGRAFIN SODIUM	BRACCO	NDA 012967	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
BILIVIST	BAYER HLTHCARE	ANDA 087768	—	Aug 11, 1982

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.

Ipodate sodium — frequently asked questions

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

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