FDA Orange Book · active-ingredient family
Canagliflozin; metformin hydrochloride
Canagliflozin; metformin hydrochloride is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:INVOKAMET XR · NDA 205879
2
Brand (NDA)
0
Generics (ANDA)
7
Listed patents
16
Exclusivity periods
Brand (NDA) products · tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| INVOKAMET XRRLD×4 | JANSSEN PHARMS | NDA 205879 | — | Sep 20, 2016 | |
| INVOKAMETRLD×4 | JANSSEN PHARMS | NDA 204353 | — | Aug 08, 2014 |
Marketing exclusivity (16)
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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 (7)
| 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 |
| 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*PED | Aug 26, 2029 | in 3 yr 3 mo | |
| 11576894 | Jul 06, 2030 | in 4 yr 1 mo | Product |
Canagliflozin; metformin hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
