Orange Book product · Brand (NDA)
QTERN
DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
At a glance
May 02, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
12
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 8221786 expires
Listed drug product patent expiration.
Mar 21, 2028
in 1 yr 9 mo
Patent 8361972 expires
Listed method-of-use patent (U-493) expiration.
Mar 21, 2028
in 1 yr 9 mo
Patent 8716251 expires
Listed drug product patent expiration.
Mar 21, 2028
in 1 yr 9 mo
Patent 8221786*PED expires
Listed listed patent expiration.
Sep 21, 2028
in 2 yr 4 mo
Patent 8361972*PED expires
Listed listed patent expiration.
Sep 21, 2028
in 2 yr 4 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
Pharmaceutical detail
Active ingredient
DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
Strength
5MG;EQ 5MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 209091
Product number
002
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 (12)
| 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 | |
| 8221786 | Mar 21, 2028 | in 1 yr 9 mo | Product |
| 8361972 | Mar 21, 2028 | in 1 yr 9 mo | U-493 |
| 8716251 | Mar 21, 2028 | in 1 yr 9 mo | Product |
| 8221786*PED | Sep 21, 2028 | in 2 yr 4 mo | |
| 8361972*PED | Sep 21, 2028 | in 2 yr 4 mo | |
| 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 |
