Is there a generic for Etidronate disodium?

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

What is the reference-listed drug for Etidronate disodium?

DIDRONEL (NDA 017831, APIL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Etidronate disodium are approved?

Etidronate disodium is approved in the following dosage forms: injectable, tablet.

FDA Orange Book · active-ingredient family

Etidronate disodium

Etidronate disodium is approved as 2 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DIDRONEL · NDA 017831

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable, tablet

Product	Applicant	Application	TE	Approved
DIDRONELRLD×2	APIL	NDA 017831	—	Approved Prior to Jan 1, 1982
DIDRONEL	MGI PHARMA INC	NDA 019545	—	Apr 20, 1987

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
ETIDRONATE DISODIUM×2	PHARMOBEDIENT	ANDA 075800	—	Jan 24, 2003

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.

Etidronate disodium — frequently asked questions

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

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