FDA Orange Book
Is there a generic for Invokamet XR?
Invokamet XR 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 XR (canagliflozin and metformin). The Orange Book shows its last listed patent expires August 26, 2029 and its last listed exclusivity ends June 18, 2028.
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Invokamet XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 150MG;1GM | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 150MG;500MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 50MG;1GM | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 50MG;500MG | Marketed (Rx) | None | 0 | None |
NDA 205879, 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 XR patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7943788 | July 14, 2027 | Drug substance, Drug product | None | 205879 |
| 8513202 | December 3, 2027 | Drug substance, Drug product | U-2441 | 205879 |
| 8513202 | December 3, 2027 | Drug substance, Drug product | U-2632 | 205879 |
| 8513202 | December 3, 2027 | Drug substance, Drug product | U-493 | 205879 |
| 7943788*PED | January 14, 2028 | Method of use | None | 205879 |
| 8513202*PED | June 3, 2028 | Method of use | None | 205879 |
| 7943582 | February 26, 2029 | Drug substance, Drug product | U-2441 | 205879 |
| 7943582 | February 26, 2029 | Drug substance, Drug product | U-2632 | 205879 |
| 7943582 | February 26, 2029 | Drug substance, Drug product | U-493 | 205879 |
| 7943582*PED | August 26, 2029 | Method of use | None | 205879 |
Invokamet XR exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NPP | New patient population | December 18, 2027 | 205879 |
| PED | Pediatric exclusivity | June 18, 2028 | 205879 |
Invokamet XR NDC codes
Questions
Is there a generic for Invokamet XR?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Invokamet XR (canagliflozin and metformin). The Orange Book shows its last listed patent expires August 26, 2029 and its last listed exclusivity ends June 18, 2028.
What is the generic name for Invokamet XR?
The active ingredient in Invokamet XR is canagliflozin and metformin, per the FDA Orange Book.
When does the Invokamet XR patent expire?
The last patent listed for Invokamet XR in the Orange Book expires August 26, 2029. 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 XR and Canagliflozin and Metformin
- What is Invokamet XR used for?FDA label uses
- Is Invokamet XR a controlled substance?Federal schedule
- Generic for InvokametFDA Orange Book
- Biguanides listFDA drug class
- Sodium-Glucose Cotransporter 2 Inhibitors listFDA drug class
- NDC 50458-940Invokamet XR NDC record
- NDC 50458-941Invokamet XR NDC record
- NDC 50458-942Invokamet XR NDC record