Orange Book product · Brand (NDA)
NESINA
ALOGLIPTIN BENZOATE
At a glance
Jan 25, 2013
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 25, 2013
13 yr 7 mo ago
Today
Exclusivity ends · M-300
New use / labeling-change exclusivity (3 years)
Jul 27, 2026
in 1 mo
Patent 7807689 expires
Listed drug substance patent expiration.
Jun 27, 2028
in 2 yr 1 mo
Patent 8697125 expires
Listed drug product patent expiration.
Jun 16, 2029
in 3 yr
Pharmaceutical detail
Active ingredient
ALOGLIPTIN BENZOATE
Strength
EQ 6.25MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 022271
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- M-300New use / labeling-change exclusivity (3 years)
Jul 27, 2026
in 1 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7807689 | Jun 27, 2028 | in 2 yr 1 mo | SubstanceProductU-1337 |
| 8697125 | Jun 16, 2029 | in 3 yr | Product |
