Is there a generic for Linagliptin?

Yes. The FDA Orange Book lists 8 approved generic (ANDA) applications for Linagliptin, referencing the brand TRADJENTA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Linagliptin?

TRADJENTA (NDA 201280, BOEHRINGER INGELHEIM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Linagliptin?

The Orange Book lists 18 patents against Linagliptin products, with the earliest listed expiry in 2025. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Linagliptin have FDA marketing exclusivity?

Yes. The Orange Book records 2 marketing-exclusivity periods for Linagliptin. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Linagliptin are approved?

Linagliptin is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Linagliptin

Linagliptin: 1 brand, 8 generics; first approved May 02, 2011; generic available.

Generic available2 exclusivity periods

Generic status & protection

Generic available — 8 ANDA applications approved.

Earliest patent expiry Nov 26, 2025Latest exclusivity ends Dec 20, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Nov 26, 2025

8 mo ago

Originator applications

Brand (NDA) products

TRADJENTARLDRS

BOEHRINGER INGELHEIMNDA 2012802011

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB

Abbreviated applications

Generic (ANDA) products (8)

LINAGLIPTIN

TEVA PHARMS USAANDA 2084332026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB

LINAGLIPTIN

AUROBINDO PHARMA LTDANDA 2084152025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB

LINAGLIPTIN

DR REDDYSANDA 2084282025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB

LINAGLIPTIN

MSNANDA 2084572025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB

LINAGLIPTIN

MYLANANDA 2084312025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB

LINAGLIPTIN

INVAGEN PHARMSANDA 2084232024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB

LINAGLIPTIN

ZYDUS PHARMSANDA 2084482023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB

LINAGLIPTIN

SUNSHINEANDA 2083352021

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (2)

M-295New use / labeling-change exclusivity (3 years)
Jun 20, 2026
24 d ago
PEDPediatric exclusivity (adds 6 months)
Dec 20, 2026
in 5 mo

Orange Book patent file

Listed patents

Listed patents (18)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8883805	Nov 26, 2025	8 mo ago	Product
8883805*PED	May 26, 2026	2 mo ago
8673927	May 04, 2027	in 10 mo	U-1503Delisted
12178819	May 04, 2027	in 10 mo	Product
11033552	May 04, 2027	in 10 mo	Product
8673927*PED	Nov 04, 2027	in 1 yr 4 mo
11033552*PED	Nov 04, 2027	in 1 yr 4 mo
9486526	Aug 05, 2029	in 3 yr 1 mo	U-1915
10034877	Aug 05, 2029	in 3 yr 1 mo	U-2347
10034877*PED	Feb 05, 2030	in 3 yr 7 mo
9486526*PED	Feb 05, 2030	in 3 yr 7 mo
11911388	Apr 10, 2030	in 3 yr 10 mo	U-3854
8846695	Jun 04, 2030	in 3 yr 11 mo	U-1503Delisted
8846695*PED	Dec 04, 2030	in 4 yr 5 mo
8853156	Mar 05, 2031	in 4 yr 9 mo	ProductU-1642
8853156*PED	Sep 05, 2031	in 5 yr 3 mo
12364700	Jun 08, 2037	in 11 yr 1 mo	U-4224
12364700*PED	Dec 08, 2037	in 11 yr 7 mo

FDA approval span

Approval history

First approval

May 02, 2011

15 yr 5 mo ago

Most recent approval

May 27, 2026

2 mo ago

Approvals span 2011–2026 across 9 FDA applications.

Brand (NDA) 111%

Generic (ANDA) 889%

Linagliptin — 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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