FDA Orange Book

Generic for Jentadueto

Jentadueto contains linagliptin 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 Jentadueto is linagliptin and metformin. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Jentadueto products in the Orange Book

Jentadueto products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	2.5MG;1GM	Marketed (Rx)	AB	4	AB
tablet, oral	2.5MG;500MG	Marketed (Rx)	AB	4	AB
tablet, oral	2.5MG;850MG	Marketed (Rx)	AB	4	AB

NDA 201281, held by BOEHRINGER INGELHEIM PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic linagliptin and metformin

Approved generic versions of Jentadueto
Company	ANDA	TE code	Approved	Strengths
SUNSHINE LAKE PHARMA CO LTD	208336	AB (A-rated, therapeutically equivalent)	August 30, 2021	2.5MG;1GM, 2.5MG;500MG, 2.5MG;850MG
ZYDUS PHARMACEUTICALS USA INC	208449	AB (A-rated, therapeutically equivalent)	March 30, 2023	2.5MG;1GM, 2.5MG;500MG, 2.5MG;850MG
DR REDDYS LABORATORIES LTD	208427	AB (A-rated, therapeutically equivalent)	November 3, 2025	2.5MG;1GM, 2.5MG;500MG, 2.5MG;850MG
MSN LABORATORIES PRIVATE LTD	208459	AB (A-rated, therapeutically equivalent)	November 3, 2025	2.5MG;1GM, 2.5MG;500MG, 2.5MG;850MG

Jentadueto patents

Patents listed for Jentadueto
Patent	Expires	Covers	Use code	NDA
8883805	November 26, 2025	Drug product	None	201281
8883805*PED	May 26, 2026	Method of use	None	201281
8673927	May 4, 2027	Method of use	U-1503	201281
8673927*PED	November 4, 2027	Method of use	None	201281
10022379	April 2, 2029	Method of use	U-2339	201281
10973827	April 2, 2029	Drug product	None	201281
9415016	April 2, 2029	Drug product	None	201281
12678442	April 2, 2029	Drug product	None	201281
10022379*PED	October 2, 2029	Method of use	None	201281
9415016*PED	October 2, 2029	Method of use	None	201281
10973827*PED	October 2, 2029	Method of use	None	201281
11911388	April 10, 2030	Method of use	U-3854	201281
9155705	May 21, 2030	Drug product	None	201281
8846695	June 4, 2030	Method of use	U-1503	201281
9155705*PED	November 21, 2030	Method of use	None	201281
8846695*PED	December 4, 2030	Method of use	None	201281
12364700	June 8, 2037	Method of use	U-4224	201281
12364700*PED	December 8, 2037	Method of use	None	201281

Jentadueto exclusivity

Exclusivity listed for Jentadueto
Code	Meaning	Expires	NDA
M-295	Miscellaneous	June 20, 2026	201281
PED	Pediatric exclusivity	December 20, 2026	201281

Jentadueto NDC codes

Questions

Is there a generic for Jentadueto?

Yes. The generic name for Jentadueto is linagliptin and metformin. 4 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 Jentadueto?

The active ingredient in Jentadueto is linagliptin and metformin, per the FDA Orange Book.

When does the Jentadueto patent expire?

The last patent listed for Jentadueto in the Orange Book expires December 8, 2037. 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.