Orange Book product · Brand (NDA)

TRADJENTA

LINAGLIPTIN

Brand (NDA)NDA 201280TE ABRX BOEHRINGER INGELHEIM

View LINAGLIPTIN family Open on FDA Orange Book

At a glance

May 02, 2011

Approved

Brand (NDA)

Application

TE code

Listed patents

Key dates

Approval
FDA approval date of this drug product.
May 02, 2011
15 yr 4 mo ago
Patent 8883805 expires
Listed drug product patent expiration.
Nov 26, 2025
7 mo ago
Patent 8883805*PED expires
Listed listed patent expiration.
May 26, 2026
24 d ago
Today
Exclusivity ends · M-295
New use / labeling-change exclusivity (3 years)
Jun 20, 2026
in 1 d
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Dec 20, 2026
in 6 mo
Patent 11033552 expires
Listed drug product patent expiration.
May 04, 2027
in 11 mo
Patent 12178819 expires
Listed drug product patent expiration.
May 04, 2027
in 11 mo
Patent 8673927 expires
Listed method-of-use patent (U-1503) expiration.
May 04, 2027
in 11 mo
Patent 11033552*PED expires
Listed listed patent expiration.
Nov 04, 2027
in 1 yr 5 mo
Patent 8673927*PED expires
Listed listed patent expiration.
Nov 04, 2027
in 1 yr 5 mo
Patent 10034877 expires
Listed method-of-use patent (U-2347) expiration.
Aug 05, 2029
in 3 yr 2 mo
Patent 9486526 expires
Listed method-of-use patent (U-1915) expiration.
Aug 05, 2029
in 3 yr 2 mo
Patent 10034877*PED expires
Listed listed patent expiration.
Feb 05, 2030
in 3 yr 8 mo
Patent 9486526*PED expires
Listed listed patent expiration.
Feb 05, 2030
in 3 yr 8 mo
Patent 11911388 expires
Listed method-of-use patent (U-3854) expiration.
Apr 10, 2030
in 3 yr 10 mo
Patent 8846695 expires
Listed method-of-use patent (U-1503) expiration.
Jun 04, 2030
in 4 yr
Patent 8846695*PED expires
Listed listed patent expiration.
Dec 04, 2030
in 4 yr 6 mo
Patent 8853156 expires
Listed drug product patent expiration.
Mar 05, 2031
in 4 yr 9 mo
Patent 8853156*PED expires
Listed listed patent expiration.
Sep 05, 2031
in 5 yr 3 mo
Patent 12364700 expires
Listed method-of-use patent (U-4224) expiration.
Jun 08, 2037
in 11 yr 2 mo
Patent 12364700*PED expires
Listed listed patent expiration.
Dec 08, 2037
in 11 yr 8 mo

Pharmaceutical detail

Active ingredient

LINAGLIPTIN

Strength

5MG

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 201280

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Marketing exclusivity (2)

M-295New use / labeling-change exclusivity (3 years)
Jun 20, 2026
in 1 d
PEDPediatric exclusivity (adds 6 months)
Dec 20, 2026
in 6 mo

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	7 mo ago	Product
8883805*PED	May 26, 2026	24 d ago
11033552	May 04, 2027	in 11 mo	Product
12178819	May 04, 2027	in 11 mo	Product
8673927	May 04, 2027	in 11 mo	U-1503Delisted
11033552*PED	Nov 04, 2027	in 1 yr 5 mo
8673927*PED	Nov 04, 2027	in 1 yr 5 mo
10034877	Aug 05, 2029	in 3 yr 2 mo	U-2347
9486526	Aug 05, 2029	in 3 yr 2 mo	U-1915
10034877*PED	Feb 05, 2030	in 3 yr 8 mo
9486526*PED	Feb 05, 2030	in 3 yr 8 mo
11911388	Apr 10, 2030	in 3 yr 10 mo	U-3854
8846695	Jun 04, 2030	in 4 yr	U-1503Delisted
8846695*PED	Dec 04, 2030	in 4 yr 6 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 2 mo	U-4224
12364700*PED	Dec 08, 2037	in 11 yr 8 mo

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