Orange Book product · Brand (NDA)
JANUMET
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
At a glance
Mar 30, 2007
Approved
Brand (NDA)
Application
AB
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 30, 2007
19 yr 6 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 8414921 expires
Listed drug product patent expiration.
Jul 21, 2028
in 2 yr 1 mo
Patent 8414921*PED expires
Listed listed patent expiration.
Jan 21, 2029
in 2 yr 8 mo
Pharmaceutical detail
Active ingredient
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Strength
1GM;EQ 50MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 022044
Product number
002
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.
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7326708 | Nov 24, 2026 | in 5 mo | SubstanceProductU-802 |
| 7326708*PED | May 24, 2027 | in 11 mo | |
| 8414921 | Jul 21, 2028 | in 2 yr 1 mo | ProductU-1036 |
| 8414921*PED | Jan 21, 2029 | in 2 yr 8 mo |
