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: 2 brands, 0 generics; first approved Nov 03, 2023.

Brand only

Generic status & protection

No listed patents or exclusivity — brand product(s) only.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

ZITUVIMET XRRLD

ZYDUS LIFESCIENCESNDA 21677820243 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG;50MG	TABLET, EXTENDED RELEASE	ORAL	Rx	—
1GM;50MG	TABLET, EXTENDED RELEASE	ORAL	Rx	—
1GM;100MG	TABLET, EXTENDED RELEASE	ORAL	Rx	—

ZITUVIMETRLDRS

ZYDUS LIFESCIENCESNDA 21674320232 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG;50MG	TABLET	ORAL	Rx	—
1GM;50MG	TABLET	ORAL	Rx	—

Orange Book patent file

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.

FDA approval span

Approval history

First approval

Nov 03, 2023

2 yr 9 mo ago

Most recent approval

Jul 18, 2024

2 yr ago

Approvals span 2023–2024 across 2 FDA applications.

Brand (NDA) 2100%

Generic (ANDA) 00%

Metformin hydrochloride; sitagliptin — frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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