FDA Orange Book

Generic for Janumet

Janumet contains sitagliptin and metformin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Janumet is sitagliptin and metformin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Janumet products in the Orange Book

Janumet products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	1GM;EQ 50MG BASE	Marketed (Rx)	AB	2	AB
tablet, oral	500MG;EQ 50MG BASE	Marketed (Rx)	AB	2	AB

NDA 022044, held by MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic sitagliptin and metformin

Approved generic versions of Janumet
Company	ANDA	TE code	Approved	Strengths
SANDOZ INC	202388	AB (A-rated, therapeutically equivalent)	December 2, 2025	1GM;EQ 50MG BASE, 500MG;EQ 50MG BASE
APOTEX INC	202426	AB (A-rated, therapeutically equivalent)	April 30, 2026	1GM;EQ 50MG BASE, 500MG;EQ 50MG BASE

Janumet patents

Patents listed for Janumet
Patent	Expires	Covers	Use code	NDA
7326708	November 24, 2026	Drug substance, Drug product	U-802	022044
7326708*PED	May 24, 2027	Method of use	None	022044
8414921	July 21, 2028	Drug product	U-1036	022044
8414921*PED	January 21, 2029	Method of use	None	022044

Janumet NDC codes

Questions

Is there a generic for Janumet?

Yes. The generic name for Janumet is sitagliptin and metformin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Janumet?

The active ingredient in Janumet is sitagliptin and metformin, per the FDA Orange Book.

When does the Janumet patent expire?

The last patent listed for Janumet in the Orange Book expires January 21, 2029. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.