FDA Orange Book
Is there a generic for Nesina?
Nesina contains 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 Nesina (alogliptin benzoate). The Orange Book shows its last listed patent expires June 16, 2029 and its last listed exclusivity ends July 27, 2026.
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Nesina products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 12.5MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 25MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 6.25MG BASE | Marketed (Rx) | None | 0 | None |
NDA 022271, 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.
Nesina patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7807689 | June 27, 2028 | Drug substance, Drug product | U-1337 | 022271 |
| 8697125 | June 16, 2029 | Drug product | None | 022271 |
Nesina exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-300 | Miscellaneous | July 27, 2026 | 022271 |
Nesina NDC codes
Questions
Is there a generic for Nesina?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Nesina (alogliptin benzoate). The Orange Book shows its last listed patent expires June 16, 2029 and its last listed exclusivity ends July 27, 2026.
What is the generic name for Nesina?
The active ingredient in Nesina is alogliptin benzoate, per the FDA Orange Book.
When does the Nesina patent expire?
The last patent listed for Nesina in the Orange Book expires June 16, 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.