FDA Orange Book
Is there a generic for Trijardy XR?
Trijardy XR contains empagliflozin, linagliptin 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 Trijardy XR (empagliflozin, linagliptin and metformin). The Orange Book shows its last listed patent expires December 8, 2037.
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Trijardy XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 10MG;5MG;1GM | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 12.5MG;2.5MG;1GM | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 25MG;5MG;1GM | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 5MG;2.5MG;1GM | Marketed (Rx) | None | 0 | None |
NDA 212614, held by BOEHRINGER INGELHEIM PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Trijardy XR patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8883805 | November 26, 2025 | Drug product | None | 212614 |
| 8883805*PED | May 26, 2026 | Method of use | None | 212614 |
| 7713938 | April 15, 2027 | Drug substance, Drug product | None | 212614 |
| 7713938*PED | October 15, 2027 | Method of use | None | 212614 |
| 7579449 | August 1, 2028 | Drug substance | None | 212614 |
| 7579449*PED | February 1, 2029 | Method of use | None | 212614 |
| 10022379 | April 2, 2029 | Drug product | U-2732 | 212614 |
| 12678442 | April 2, 2029 | Drug product | None | 212614 |
| 9415016 | April 2, 2029 | Drug product | None | 212614 |
| 12678442*PED | October 2, 2029 | Method of use | None | 212614 |
| 8551957 | October 14, 2029 | Drug product | U-2730 | 212614 |
| 12115179 | February 11, 2030 | Method of use | U-4023 | 212614 |
| 8551957*PED | April 14, 2030 | Method of use | None | 212614 |
| 9155705 | May 21, 2030 | Drug product | None | 212614 |
| 10406172 | June 15, 2030 | Drug product | U-2733 | 212614 |
| 12115179*PED | August 11, 2030 | Method of use | None | 212614 |
| 11564886 | March 7, 2032 | Drug product | U-3531 | 212614 |
| 10596120 | March 7, 2032 | Drug product | U-2790 | 212614 |
| 10596120 | March 7, 2032 | Drug product | U-2776 | 212614 |
| 10258637 | April 3, 2034 | Method of use | U-2731 | 212614 |
| 11090323 | April 3, 2034 | Method of use | U-3192 | 212614 |
| 11833166 | April 3, 2034 | Method of use | U-3776 | 212614 |
| 11833166 | April 3, 2034 | Method of use | U-3777 | 212614 |
| 9949998 | June 11, 2034 | Method of use | U-2731 | 212614 |
| 10258637*PED | October 3, 2034 | Method of use | None | 212614 |
| 11833166*PED | October 3, 2034 | Method of use | None | 212614 |
| 11090323*PED | October 3, 2034 | Method of use | None | 212614 |
| 9949998*PED | December 11, 2034 | Method of use | None | 212614 |
| 12364700 | June 8, 2037 | Method of use | U-4224 | 212614 |
| 12364700*PED | December 8, 2037 | Method of use | None | 212614 |
Trijardy XR NDC codes
Questions
Is there a generic for Trijardy XR?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Trijardy XR (empagliflozin, linagliptin and metformin). The Orange Book shows its last listed patent expires December 8, 2037.
What is the generic name for Trijardy XR?
The active ingredient in Trijardy XR is empagliflozin, linagliptin and metformin, per the FDA Orange Book.
When does the Trijardy XR patent expire?
The last patent listed for Trijardy XR in the Orange Book expires December 8, 2037. 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 Trijardy XR and Empagliflozin, Linagliptin and Metformin
- What is Trijardy XR used for?FDA label uses
- Is Trijardy XR a controlled substance?Federal schedule
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- NDC 0597-0380Trijardy XR NDC record
- NDC 0597-0385Trijardy XR NDC record
- NDC 0597-0390Trijardy XR NDC record