Orange Book product · Brand (NDA)
JANUVIA
SITAGLIPTIN PHOSPHATE
Brand (NDA)NDA 021995TE ABRX MSD
At a glance
Oct 16, 2006
Approved
Brand (NDA)
Application
AB
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 16, 2006
20 yr 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
Pharmaceutical detail
Active ingredient
SITAGLIPTIN PHOSPHATE
Strength
EQ 25MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021995
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 (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7326708 | Nov 24, 2026 | in 5 mo | SubstanceProductU-802 |
| 7326708*PED | May 24, 2027 | in 11 mo |
