FDA Orange Book
Is there a generic for Invokamet?
Invokamet contains canagliflozin and metformin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Invokamet (canagliflozin and metformin). The Orange Book shows its last listed patent expires July 6, 2030 and its last listed exclusivity ends June 18, 2028.
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Invokamet products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 150MG;1GM | Marketed (Rx) | None | 0 | None |
| tablet, oral | 150MG;500MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 50MG;1GM | Marketed (Rx) | None | 0 | None |
| tablet, oral | 50MG;500MG | Marketed (Rx) | None | 0 | None |
NDA 204353, held by JANSSEN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Invokamet patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7943788 | July 14, 2027 | Drug substance, Drug product | None | 204353 |
| 8513202 | December 3, 2027 | Drug substance, Drug product | U-2441 | 204353 |
| 8513202 | December 3, 2027 | Drug substance, Drug product | U-2632 | 204353 |
| 8513202 | December 3, 2027 | Drug substance, Drug product | U-493 | 204353 |
| 7943788*PED | January 14, 2028 | Method of use | None | 204353 |
| 8513202*PED | June 3, 2028 | Method of use | None | 204353 |
| 7943582 | February 26, 2029 | Drug substance, Drug product | U-493 | 204353 |
| 7943582 | February 26, 2029 | Drug substance, Drug product | U-2441 | 204353 |
| 7943582 | February 26, 2029 | Drug substance, Drug product | U-2632 | 204353 |
| 7943582*PED | August 26, 2029 | Method of use | None | 204353 |
| 11576894 | July 6, 2030 | Drug product | None | 204353 |
Invokamet exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NPP | New patient population | December 18, 2027 | 204353 |
| PED | Pediatric exclusivity | June 18, 2028 | 204353 |
Invokamet NDC codes
Questions
Is there a generic for Invokamet?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Invokamet (canagliflozin and metformin). The Orange Book shows its last listed patent expires July 6, 2030 and its last listed exclusivity ends June 18, 2028.
What is the generic name for Invokamet?
The active ingredient in Invokamet is canagliflozin and metformin, per the FDA Orange Book.
When does the Invokamet patent expire?
The last patent listed for Invokamet in the Orange Book expires July 6, 2030. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.
More on Invokamet and Canagliflozin and Metformin
- What is Invokamet used for?FDA label uses
- Is Invokamet a controlled substance?Federal schedule
- Generic for Invokamet XRFDA Orange Book
- Biguanides listFDA drug class
- Sodium-Glucose Cotransporter 2 Inhibitors listFDA drug class
- NDC 50458-540Invokamet NDC record
- NDC 50458-541Invokamet NDC record
- NDC 50458-542Invokamet NDC record