Orange Book product · Brand (NDA)
JENTADUETO
LINAGLIPTIN; METFORMIN HYDROCHLORIDE
At a glance
Jan 30, 2012
Approved
Brand (NDA)
Application
AB
TE code
17
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 30, 2012
14 yr 7 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 8673927*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 10973827 expires
Listed drug product patent 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 10973827*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 8846695 expires
Listed method-of-use patent (U-1503) expiration.
Jun 04, 2030
in 4 yr
Patent 9155705*PED expires
Listed listed patent expiration.
Nov 21, 2030
in 4 yr 6 mo
Patent 8846695*PED expires
Listed listed patent expiration.
Dec 04, 2030
in 4 yr 6 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
Route
ORAL
TE code
AB
Application
NDA 201281
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2016JENTADUETO XRBrand (NDA)
NDA 208026 · BOEHRINGER INGELHEIM
- 2025LINAGLIPTIN AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 208427 · DR REDDYS
- 2025LINAGLIPTIN AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 208459 · MSN
- 2023LINAGLIPTIN AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 208449 · ZYDUS PHARMS
- 2021LINAGLIPTIN AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 208336 · SUNSHINE
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 (17)
| 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 |
| 8673927*PED | Nov 04, 2027 | in 1 yr 5 mo | |
| 10022379 | Apr 02, 2029 | in 2 yr 10 mo | U-2339 |
| 10973827 | Apr 02, 2029 | in 2 yr 10 mo | Product |
| 9415016 | Apr 02, 2029 | in 2 yr 10 mo | Product |
| 10022379*PED | Oct 02, 2029 | in 3 yr 4 mo | |
| 10973827*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 |
| 8846695 | Jun 04, 2030 | in 4 yr | U-1503Delisted |
| 9155705*PED | Nov 21, 2030 | in 4 yr 6 mo | |
| 8846695*PED | Dec 04, 2030 | in 4 yr 6 mo | |
| 12364700 | Jun 08, 2037 | in 11 yr 2 mo | U-4224 |
| 12364700*PED | Dec 08, 2037 | in 11 yr 8 mo |
