FDA Orange Book
Generic for Onglyza
Onglyza contains 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 Onglyza is saxagliptin. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Onglyza products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 2.5MG BASE | Discontinued | None | 3 | AB |
| tablet, oral | EQ 5MG BASE | Discontinued | None | 3 | AB |
NDA 022350, 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 saxagliptin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA LTD | 205972 | AB (A-rated, therapeutically equivalent) | July 31, 2023 | EQ 2.5MG BASE, EQ 5MG BASE |
| GLENMARK PHARMACEUTICALS LTD | 205994 | AB (A-rated, therapeutically equivalent) | July 31, 2023 | EQ 2.5MG BASE, EQ 5MG BASE |
| MYLAN PHARMACEUTICALS INC | 205980 | AB (A-rated, therapeutically equivalent) | July 31, 2023 | EQ 2.5MG BASE, EQ 5MG BASE |
Onglyza patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7951400 | November 30, 2028 | Drug product | None | 022350 |
Onglyza exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-14 | Miscellaneous | October 11, 2027 | 022350 |
Questions
Is there a generic for Onglyza?
Yes. The generic name for Onglyza is saxagliptin. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Onglyza?
The active ingredient in Onglyza is saxagliptin, per the FDA Orange Book.
When does the Onglyza patent expire?
The last patent listed for Onglyza in the Orange Book expires November 30, 2028. 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.