FDA Orange Book
Is there a generic for Kazano?
Kazano contains metformin and alogliptin benzoate. 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 Kazano (metformin and alogliptin benzoate). The Orange Book shows its last listed patent expires May 24, 2029 and its last listed exclusivity ends July 27, 2026.
Run it in Rivvi
Map Kazano and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Kazano products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 12.5MG BASE;1GM | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 12.5MG BASE;500MG | Marketed (Rx) | None | 0 | None |
NDA 203414, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Kazano patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7807689 | June 27, 2028 | Drug substance, Drug product | U-1337 | 203414 |
| 8900638 | May 24, 2029 | Drug product | None | 203414 |
Kazano exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-300 | Miscellaneous | July 27, 2026 | 203414 |
Kazano NDC codes
Questions
Is there a generic for Kazano?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Kazano (metformin and alogliptin benzoate). The Orange Book shows its last listed patent expires May 24, 2029 and its last listed exclusivity ends July 27, 2026.
What is the generic name for Kazano?
The active ingredient in Kazano is metformin and alogliptin benzoate, per the FDA Orange Book.
When does the Kazano patent expire?
The last patent listed for Kazano in the Orange Book expires May 24, 2029. 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.