FDA Orange Book
Generic for Kombiglyze XR
Kombiglyze XR contains saxagliptin 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
Yes. The generic name for Kombiglyze XR is saxagliptin and metformin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Kombiglyze XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 1GM;EQ 2.5MG BASE | Discontinued | None | 2 | AB |
| tablet, extended release, oral | 1GM;EQ 5MG BASE | Discontinued | None | 2 | AB |
| tablet, extended release, oral | 500MG;EQ 5MG BASE | Discontinued | None | 2 | AB |
NDA 200678, 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 and metformin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 205981 | AB (A-rated, therapeutically equivalent) | July 31, 2023 | 1GM;EQ 2.5MG BASE, 1GM;EQ 5MG BASE, 500MG;EQ 5MG BASE |
| DR REDDYS LABORATORIES SA | 207678 | AB (A-rated, therapeutically equivalent) | August 9, 2023 | 1GM;EQ 2.5MG BASE, 1GM;EQ 5MG BASE, 500MG;EQ 5MG BASE |
Kombiglyze XR exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-14 | Miscellaneous | October 11, 2027 | 200678 |
Questions
Is there a generic for Kombiglyze XR?
Yes. The generic name for Kombiglyze XR is saxagliptin and metformin. 2 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 Kombiglyze XR?
The active ingredient in Kombiglyze XR is saxagliptin and metformin, per the FDA Orange Book.
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.