Is there a generic for Metformin hydrochloride; sitagliptin?

The FDA Orange Book does not currently list an approved generic (ANDA) for Metformin hydrochloride; sitagliptin. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Metformin hydrochloride; sitagliptin?

ZITUVIMET XR (NDA 216778, ZYDUS LIFESCIENCES) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Metformin hydrochloride; sitagliptin are approved?

Metformin hydrochloride; sitagliptin is approved in the following dosage forms: tablet, tablet, extended release.

FDA Orange Book · active-ingredient family

Metformin hydrochloride; sitagliptin

Metformin hydrochloride; sitagliptin is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:ZITUVIMET XR · NDA 216778

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet, tablet, extended release

Product	Applicant	Application	TE	Approved
ZITUVIMET XRRLD×3	ZYDUS LIFESCIENCES	NDA 216778	—	Jul 18, 2024
ZITUVIMETRLD×2	ZYDUS LIFESCIENCES	NDA 216743	—	Nov 03, 2023

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.

Metformin hydrochloride; sitagliptin — frequently asked questions

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

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