FDA Orange Book

Generic for Januvia

Januvia contains sitagliptin. 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 Januvia is sitagliptin. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Januvia products in the Orange Book

Januvia products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	EQ 100MG BASE	Marketed (Rx)	AB	3	AB
tablet, oral	EQ 25MG BASE	Marketed (Rx)	AB	3	AB
tablet, oral	EQ 50MG BASE	Marketed (Rx)	AB	3	AB

NDA 021995, held by MERCK SHARP AND DOHME LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic sitagliptin

Approved generic versions of Januvia
Company	ANDA	TE code	Approved	Strengths
WATSON LABORATORIES INC	202327	AB (A-rated, therapeutically equivalent)	December 30, 2025	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
SANDOZ INC	202387	AB (A-rated, therapeutically equivalent)	January 14, 2026	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
APOTEX INC	202425	AB (A-rated, therapeutically equivalent)	January 20, 2026	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE

Januvia patents

Patents listed for Januvia
Patent	Expires	Covers	Use code	NDA
7326708	November 24, 2026	Drug substance, Drug product	U-802	021995
7326708*PED	May 24, 2027	Method of use	None	021995

Januvia NDC codes

Questions

Is there a generic for Januvia?

Yes. The generic name for Januvia is sitagliptin. 3 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 Januvia?

The active ingredient in Januvia is sitagliptin, per the FDA Orange Book.

When does the Januvia patent expire?

The last patent listed for Januvia in the Orange Book expires May 24, 2027. 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.