FDA Orange Book
Is there a generic for Synjardy XR?
Synjardy XR contains empagliflozin 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 Synjardy XR (empagliflozin and metformin). The Orange Book shows its last listed patent expires December 11, 2034 and its last listed exclusivity ends December 20, 2026.
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Synjardy XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 10MG;1GM | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 12.5MG;1GM | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 25MG;1GM | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 5MG;1GM | Marketed (Rx) | None | 0 | None |
NDA 208658, 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.
Synjardy XR patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7713938 | April 15, 2027 | Drug substance, Drug product | None | 208658 |
| 7713938*PED | October 15, 2027 | Method of use | None | 208658 |
| 7579449 | August 1, 2028 | Drug substance | None | 208658 |
| 7579449*PED | February 1, 2029 | Method of use | None | 208658 |
| 12115179 | February 11, 2030 | Method of use | U-4023 | 208658 |
| 12115179*PED | August 11, 2030 | Method of use | None | 208658 |
| 10596120 | March 7, 2032 | Drug product | U-2775 | 208658 |
| 10596120 | March 7, 2032 | Drug product | U-2792 | 208658 |
| 10596120*PED | September 7, 2032 | Method of use | None | 208658 |
| 12433906 | April 3, 2034 | Method of use | U-4304 | 208658 |
| 11666590 | April 3, 2034 | Method of use | U-4154 | 208658 |
| 12263153 | April 3, 2034 | Method of use | U-4154 | 208658 |
| 12427162 | April 3, 2034 | Method of use | U-4287 | 208658 |
| 12433906 | April 3, 2034 | Method of use | U-4293 | 208658 |
| 12433906 | April 3, 2034 | Method of use | U-4294 | 208658 |
| 12433906 | April 3, 2034 | Method of use | U-4295 | 208658 |
| 12433906 | April 3, 2034 | Method of use | U-4296 | 208658 |
| 10258637 | April 3, 2034 | Method of use | U-2290 | 208658 |
| 11833166 | April 3, 2034 | Method of use | U-3776 | 208658 |
| 11833166 | April 3, 2034 | Method of use | U-3777 | 208658 |
| 11090323 | April 3, 2034 | Method of use | U-3193 | 208658 |
| 11813275 | April 3, 2034 | Method of use | U-3759 | 208658 |
| 9949997 | May 17, 2034 | Method of use | U-3532 | 208658 |
| 9949997 | May 17, 2034 | Method of use | U-3533 | 208658 |
| 9949998 | June 11, 2034 | Method of use | U-2290 | 208658 |
| 10258637*PED | October 3, 2034 | Method of use | None | 208658 |
| 11813275*PED | October 3, 2034 | Method of use | None | 208658 |
| 11833166*PED | October 3, 2034 | Method of use | None | 208658 |
| 11090323*PED | October 3, 2034 | Method of use | None | 208658 |
| 12433906*PED | October 3, 2034 | Method of use | None | 208658 |
| 9949997*PED | November 17, 2034 | Method of use | None | 208658 |
| 9949998*PED | December 11, 2034 | Method of use | None | 208658 |
Synjardy XR exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-296 | Miscellaneous | June 20, 2026 | 208658 |
| PED | Pediatric exclusivity | December 20, 2026 | 208658 |
Synjardy XR NDC codes
Questions
Is there a generic for Synjardy XR?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Synjardy XR (empagliflozin and metformin). The Orange Book shows its last listed patent expires December 11, 2034 and its last listed exclusivity ends December 20, 2026.
What is the generic name for Synjardy XR?
The active ingredient in Synjardy XR is empagliflozin and metformin, per the FDA Orange Book.
When does the Synjardy XR patent expire?
The last patent listed for Synjardy XR in the Orange Book expires December 11, 2034. 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.