Orange Book product · Brand (NDA)

JENTADUETO XR

LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Brand (NDA)NDA 208026RX BOEHRINGER INGELHEIM

View LINAGLIPTIN; METFORMIN HYDROCHLORIDE family Open on FDA Orange Book

At a glance

May 27, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Key dates

Approval
FDA approval date of this drug product.
May 27, 2016
10 yr 3 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 8673927 expires
Listed method-of-use patent (U-1503) expiration.
May 04, 2027
in 11 mo
Patent 9173859 expires
Listed drug product patent expiration.
May 04, 2027
in 11 mo
Patent 8673927*PED expires
Listed listed patent expiration.
Nov 04, 2027
in 1 yr 5 mo
Patent 9173859*PED expires
Listed listed patent expiration.
Nov 04, 2027
in 1 yr 5 mo
Patent 10022379 expires
Listed method-of-use patent (U-2339) expiration.
Apr 02, 2029
in 2 yr 10 mo
Patent 9415016 expires
Listed drug product patent expiration.
Apr 02, 2029
in 2 yr 10 mo
Patent 10022379*PED expires
Listed listed patent expiration.
Oct 02, 2029
in 3 yr 4 mo
Patent 9415016*PED expires
Listed listed patent expiration.
Oct 02, 2029
in 3 yr 4 mo
Patent 11911388 expires
Listed method-of-use patent (U-3854) expiration.
Apr 10, 2030
in 3 yr 10 mo
Patent 9155705 expires
Listed drug product patent expiration.
May 21, 2030
in 4 yr
Patent 9155705*PED expires
Listed listed patent expiration.
Nov 21, 2030
in 4 yr 6 mo
Patent 9555001 expires
Listed drug product patent expiration.
Mar 06, 2033
in 6 yr 10 mo
Patent 9555001 expires
Listed drug product patent expiration.
Mar 06, 2033
in 6 yr 10 mo
Patent 9555001*PED expires
Listed listed patent expiration.
Sep 06, 2033
in 7 yr 4 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; METFORMIN HYDROCHLORIDE

Strength

2.5MG;1GM

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 208026

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

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
8673927	May 04, 2027	in 11 mo	U-1503Delisted
9173859	May 04, 2027	in 11 mo	ProductU-1503Delisted
8673927*PED	Nov 04, 2027	in 1 yr 5 mo
9173859*PED	Nov 04, 2027	in 1 yr 5 mo
10022379	Apr 02, 2029	in 2 yr 10 mo	U-2339
9415016	Apr 02, 2029	in 2 yr 10 mo	Product
10022379*PED	Oct 02, 2029	in 3 yr 4 mo
9415016*PED	Oct 02, 2029	in 3 yr 4 mo
11911388	Apr 10, 2030	in 3 yr 10 mo	U-3854
9155705	May 21, 2030	in 4 yr	Product
9155705*PED	Nov 21, 2030	in 4 yr 6 mo
9555001	Mar 06, 2033	in 6 yr 10 mo	ProductU-1967
9555001	Mar 06, 2033	in 6 yr 10 mo	ProductU-1968
9555001*PED	Sep 06, 2033	in 7 yr 4 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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