FDA Orange Book
Is there a generic for Glyxambi?
Glyxambi contains empagliflozin and linagliptin. 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 Glyxambi (empagliflozin and linagliptin). The Orange Book shows its last listed patent expires December 8, 2037.
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Glyxambi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG;5MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 25MG;5MG | Marketed (Rx) | None | 0 | None |
NDA 206073, held by BOEHRINGER INGELHEIM. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Glyxambi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8883805 | November 26, 2025 | Drug product | None | 206073 |
| 8883805*PED | May 26, 2026 | Method of use | None | 206073 |
| 7713938 | April 15, 2027 | Drug substance, Drug product | None | 206073 |
| 9173859 | May 4, 2027 | Drug product | U-1772 | 206073 |
| 8673927 | May 4, 2027 | Method of use | U-1652 | 206073 |
| 11033552 | May 4, 2027 | Drug product | None | 206073 |
| 12178819 | May 4, 2027 | Drug product | None | 206073 |
| 7713938*PED | October 15, 2027 | Method of use | None | 206073 |
| 8673927*PED | November 4, 2027 | Method of use | None | 206073 |
| 11033552*PED | November 4, 2027 | Method of use | None | 206073 |
| 7579449 | August 1, 2028 | Drug substance | None | 206073 |
| 7579449*PED | February 1, 2029 | Method of use | None | 206073 |
| 8551957 | October 14, 2029 | Drug product | U-1651 | 206073 |
| 12115179 | February 11, 2030 | Method of use | U-4023 | 206073 |
| 8551957*PED | April 14, 2030 | Method of use | None | 206073 |
| 12115179*PED | August 11, 2030 | Method of use | None | 206073 |
| 10258637 | April 3, 2034 | Method of use | U-2290 | 206073 |
| 12433906 | April 3, 2034 | Method of use | U-4304 | 206073 |
| 12433906 | April 3, 2034 | Method of use | U-4293 | 206073 |
| 12433906 | April 3, 2034 | Method of use | U-4294 | 206073 |
| 12433906 | April 3, 2034 | Method of use | U-4295 | 206073 |
| 12433906 | April 3, 2034 | Method of use | U-4296 | 206073 |
| 11090323 | April 3, 2034 | Method of use | U-3191 | 206073 |
| 11833166 | April 3, 2034 | Method of use | U-3776 | 206073 |
| 11833166 | April 3, 2034 | Method of use | U-3777 | 206073 |
| 9949998 | June 11, 2034 | Method of use | U-2290 | 206073 |
| 10258637*PED | October 3, 2034 | Method of use | None | 206073 |
| 12433906*PED | October 3, 2034 | Method of use | None | 206073 |
| 11833166*PED | October 3, 2034 | Method of use | None | 206073 |
| 11090323*PED | October 3, 2034 | Method of use | None | 206073 |
| 12364700 | June 8, 2037 | Method of use | U-4224 | 206073 |
| 12364700*PED | December 8, 2037 | Method of use | None | 206073 |
Glyxambi NDC codes
Questions
Is there a generic for Glyxambi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Glyxambi (empagliflozin and linagliptin). The Orange Book shows its last listed patent expires December 8, 2037.
What is the generic name for Glyxambi?
The active ingredient in Glyxambi is empagliflozin and linagliptin, per the FDA Orange Book.
When does the Glyxambi patent expire?
The last patent listed for Glyxambi 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.