Orange Book product · Brand (NDA)
STEGLUJAN
ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE
At a glance
Dec 19, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 19, 2017
8 yr 7 mo ago
Today
Patent 7326708 expires
Listed drug substance patent expiration.
Nov 24, 2026
in 5 mo
Patent 7326708*PED expires
Listed listed patent expiration.
May 24, 2027
in 11 mo
Patent 9308204 expires
Listed drug product patent expiration.
Oct 21, 2030
in 4 yr 5 mo
Patent 9439901 expires
Listed method-of-use patent (U-2214) expiration.
Oct 21, 2030
in 4 yr 5 mo
Patent 8080580 expires
Listed drug substance patent expiration.
Dec 19, 2031
in 5 yr 7 mo
Pharmaceutical detail
Active ingredient
ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE
Strength
5MG;EQ 100MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 209805
Product number
001
Marketing status
RX
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 (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7326708 | Nov 24, 2026 | in 5 mo | SubstanceProductU-2214 |
| 7326708*PED | May 24, 2027 | in 11 mo | |
| 9308204 | Oct 21, 2030 | in 4 yr 5 mo | Product |
| 9439901 | Oct 21, 2030 | in 4 yr 5 mo | U-2214 |
| 8080580 | Dec 19, 2031 | in 5 yr 7 mo | SubstanceProductU-2214 |
