Orange Book product · Brand (NDA)
INVOKAMET XR
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
At a glance
Sep 20, 2016
Approved
Brand (NDA)
Application
Not listed
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 20, 2016
9 yr 11 mo ago
Today
Patent 7943788 expires
Listed drug substance patent expiration.
Jul 14, 2027
in 1 yr 1 mo
Patent 8513202 expires
Listed drug substance patent expiration.
Dec 03, 2027
in 1 yr 6 mo
Patent 8513202 expires
Listed drug substance patent expiration.
Dec 03, 2027
in 1 yr 6 mo
Patent 8513202 expires
Listed drug substance patent expiration.
Dec 03, 2027
in 1 yr 6 mo
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Dec 18, 2027
in 1 yr 6 mo
Patent 7943788*PED expires
Listed listed patent expiration.
Jan 14, 2028
in 1 yr 7 mo
Patent 8513202*PED expires
Listed listed patent expiration.
Jun 03, 2028
in 2 yr
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Jun 18, 2028
in 2 yr
Patent 7943582 expires
Listed drug substance patent expiration.
Feb 26, 2029
in 2 yr 9 mo
Patent 7943582 expires
Listed drug substance patent expiration.
Feb 26, 2029
in 2 yr 9 mo
Patent 7943582 expires
Listed drug substance patent expiration.
Feb 26, 2029
in 2 yr 9 mo
Patent 7943582*PED expires
Listed listed patent expiration.
Aug 26, 2029
in 3 yr 3 mo
Pharmaceutical detail
Active ingredient
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Strength
50MG;1GM
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 205879
Product number
002
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.
Marketing exclusivity (2)
- NPPNew patient population exclusivity (3 years)
Dec 18, 2027
in 1 yr 6 mo
- PEDPediatric exclusivity (adds 6 months)
Jun 18, 2028
in 2 yr
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7943788 | Jul 14, 2027 | in 1 yr 1 mo | SubstanceProduct |
| 8513202 | Dec 03, 2027 | in 1 yr 6 mo | SubstanceProductU-2441 |
| 8513202 | Dec 03, 2027 | in 1 yr 6 mo | SubstanceProductU-2632 |
| 8513202 | Dec 03, 2027 | in 1 yr 6 mo | SubstanceProductU-493 |
| 7943788*PED | Jan 14, 2028 | in 1 yr 7 mo | |
| 8513202*PED | Jun 03, 2028 | in 2 yr | |
| 7943582 | Feb 26, 2029 | in 2 yr 9 mo | SubstanceProductU-2441 |
| 7943582 | Feb 26, 2029 | in 2 yr 9 mo | SubstanceProductU-2632 |
| 7943582 | Feb 26, 2029 | in 2 yr 9 mo | SubstanceProductU-493 |
| 7943582*PED | Aug 26, 2029 | in 3 yr 3 mo |
