FDA Orange Book
Is there a generic for Zituvio?
Zituvio contains sitagliptin. 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 Zituvio (sitagliptin). The Orange Book shows its last listed patent expires February 25, 2035.
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Zituvio products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 25MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 50MG | Marketed (Rx) | None | 0 | None |
NDA 211566, held by ZYDUS LIFESCIENCES GLOBAL FZE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zituvio patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10925871 | February 25, 2035 | Drug product | None | 211566 |
Zituvio NDC codes
Questions
Is there a generic for Zituvio?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zituvio (sitagliptin). The Orange Book shows its last listed patent expires February 25, 2035.
What is the generic name for Zituvio?
The active ingredient in Zituvio is sitagliptin, per the FDA Orange Book.
When does the Zituvio patent expire?
The last patent listed for Zituvio in the Orange Book expires February 25, 2035. 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.
More on Zituvio and Sitagliptin
- What is Sitagliptin used for?FDA label uses
- Is Sitagliptin a controlled substance?Federal schedule
- Generic for JanuviaFDA Orange Book
- Dipeptidyl Peptidase 4 Inhibitors listFDA drug class
- Zituvio Medicare Part D coverageBy plan and state
- NDC 70710-1240Zituvio NDC record
- NDC 70710-1241Zituvio NDC record
- NDC 70710-1242Zituvio NDC record