Orange Book product · Brand (NDA)
KAZANO
ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE
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 8900638 expires
Listed drug product patent expiration.
May 24, 2029
in 3 yr
Pharmaceutical detail
Active ingredient
ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE
Strength
EQ 12.5MG BASE;1GM
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 203414
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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 |
| 8900638 | May 24, 2029 | in 3 yr | Product |
