Orange Book product · Brand (NDA)
QTERNMET XR
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
At a glance
May 02, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 02, 2019
7 yr 3 mo ago
Patent 6515117 expires
Listed drug substance patent expiration.
Oct 04, 2025
9 mo ago
Patent 6515117*PED expires
Listed listed patent expiration.
Apr 04, 2026
3 mo ago
Today
Patent 8501698 expires
Listed drug product patent expiration.
Jun 20, 2027
in 1 yr
Patent 8501698*PED expires
Listed listed patent expiration.
Dec 20, 2027
in 1 yr 6 mo
Patent 8716251 expires
Listed drug product patent expiration.
Mar 21, 2028
in 1 yr 9 mo
Patent 8716251*PED expires
Listed listed patent expiration.
Sep 21, 2028
in 2 yr 4 mo
Patent 7919598 expires
Listed drug substance patent expiration.
Dec 16, 2029
in 3 yr 7 mo
Patent 7919598*PED expires
Listed listed patent expiration.
Jun 16, 2030
in 4 yr 1 mo
Patent 9616028 expires
Listed drug product patent expiration.
Nov 12, 2030
in 4 yr 6 mo
Patent 9616028*PED expires
Listed listed patent expiration.
May 12, 2031
in 5 yr
Pharmaceutical detail
Active ingredient
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Strength
2.5MG;1GM;EQ 2.5MG BASE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 210874
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 6515117 | Oct 04, 2025 | 9 mo ago | SubstanceProductU-493 |
| 6515117*PED | Apr 04, 2026 | 3 mo ago | |
| 8501698 | Jun 20, 2027 | in 1 yr | ProductU-493 |
| 8501698*PED | Dec 20, 2027 | in 1 yr 6 mo | |
| 8716251 | Mar 21, 2028 | in 1 yr 9 mo | Product |
| 8716251*PED | Sep 21, 2028 | in 2 yr 4 mo | |
| 7919598 | Dec 16, 2029 | in 3 yr 7 mo | Substance |
| 7919598*PED | Jun 16, 2030 | in 4 yr 1 mo | |
| 9616028 | Nov 12, 2030 | in 4 yr 6 mo | Product |
| 9616028*PED | May 12, 2031 | in 5 yr |

