FDA Orange Book
Generic for Qtern
Qtern contains dapagliflozin and saxagliptin. 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
Yes. The generic name for Qtern is dapagliflozin and saxagliptin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Qtern products the Orange Book lists.
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Qtern products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG;EQ 5MG BASE | Discontinued | None | 2 | AB |
| tablet, oral | 5MG;EQ 5MG BASE | Discontinued | None | 0 | None |
NDA 209091, held by ASTRAZENECA AB. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dapagliflozin and saxagliptin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MSN LABORATORIES PRIVATE LTD | 211533 | AB (A-rated, therapeutically equivalent) | April 6, 2026 | 10MG;EQ 5MG BASE |
| TORRENT PHARMACEUTICALS LTD | 211537 | AB (A-rated, therapeutically equivalent) | April 6, 2026 | 10MG;EQ 5MG BASE |
Qtern patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 6515117 | October 4, 2025 | Drug substance, Drug product | U-493 | 209091 |
| 6515117*PED | April 4, 2026 | Method of use | None | 209091 |
| 8501698 | June 20, 2027 | Drug product | U-493 | 209091 |
| 8501698 | June 20, 2027 | Drug product | U-1976 | 209091 |
| 8501698 | June 20, 2027 | Drug product | U-1977 | 209091 |
| 8501698*PED | December 20, 2027 | Method of use | None | 209091 |
| 8361972 | March 21, 2028 | Method of use | U-493 | 209091 |
| 8716251 | March 21, 2028 | Drug product | None | 209091 |
| 8221786 | March 21, 2028 | Drug product | None | 209091 |
| 8361972 | March 21, 2028 | Method of use | U-1977 | 209091 |
| 8361972 | March 21, 2028 | Method of use | U-1976 | 209091 |
| 8221786*PED | September 21, 2028 | Method of use | None | 209091 |
| 8716251*PED | September 21, 2028 | Method of use | None | 209091 |
| 8361972*PED | September 21, 2028 | Method of use | None | 209091 |
| 7919598 | December 16, 2029 | Drug substance | None | 209091 |
| 7919598*PED | June 16, 2030 | Method of use | None | 209091 |
Questions
Is there a generic for Qtern?
Yes. The generic name for Qtern is dapagliflozin and saxagliptin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Qtern products the Orange Book lists.
What is the generic name for Qtern?
The active ingredient in Qtern is dapagliflozin and saxagliptin, per the FDA Orange Book.
When does the Qtern patent expire?
The last patent listed for Qtern in the Orange Book expires June 16, 2030. 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.