FDA Orange Book
Is there a generic for Jentadueto XR?
Jentadueto XR contains 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 Jentadueto XR (linagliptin and metformin). The Orange Book shows its last listed patent expires December 8, 2037 and its last listed exclusivity ends December 20, 2026.
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Jentadueto XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 2.5MG;1GM | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 5MG;1GM | Marketed (Rx) | None | 0 | None |
NDA 208026, 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.
Jentadueto XR patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8883805 | November 26, 2025 | Drug product | None | 208026 |
| 8883805*PED | May 26, 2026 | Method of use | None | 208026 |
| 9173859 | May 4, 2027 | Drug product | U-1503 | 208026 |
| 8673927 | May 4, 2027 | Method of use | U-1503 | 208026 |
| 9173859*PED | November 4, 2027 | Method of use | None | 208026 |
| 8673927*PED | November 4, 2027 | Method of use | None | 208026 |
| 10022379 | April 2, 2029 | Method of use | U-2339 | 208026 |
| 9415016 | April 2, 2029 | Drug product | None | 208026 |
| 12678442 | April 2, 2029 | Drug product | None | 208026 |
| 10022379*PED | October 2, 2029 | Method of use | None | 208026 |
| 9415016*PED | October 2, 2029 | Method of use | None | 208026 |
| 11911388 | April 10, 2030 | Method of use | U-3854 | 208026 |
| 9155705 | May 21, 2030 | Drug product | None | 208026 |
| 9155705*PED | November 21, 2030 | Method of use | None | 208026 |
| 9555001 | March 6, 2033 | Drug product | U-1967 | 208026 |
| 9555001 | March 6, 2033 | Drug product | U-1968 | 208026 |
| 9555001*PED | September 6, 2033 | Method of use | None | 208026 |
| 12364700 | June 8, 2037 | Method of use | U-4224 | 208026 |
| 12364700*PED | December 8, 2037 | Method of use | None | 208026 |
Jentadueto XR exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-295 | Miscellaneous | June 20, 2026 | 208026 |
| PED | Pediatric exclusivity | December 20, 2026 | 208026 |
Jentadueto XR NDC codes
Questions
Is there a generic for Jentadueto XR?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Jentadueto XR (linagliptin and metformin). The Orange Book shows its last listed patent expires December 8, 2037 and its last listed exclusivity ends December 20, 2026.
What is the generic name for Jentadueto XR?
The active ingredient in Jentadueto XR is linagliptin and metformin, per the FDA Orange Book.
When does the Jentadueto XR patent expire?
The last patent listed for Jentadueto 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.