Orange Book product · Brand (NDA)
INPEFA
SOTAGLIFLOZIN
At a glance
May 26, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 26, 2023
3 yr 1 mo ago
Today
Patent 7781577 expires
Listed drug substance patent expiration.
May 04, 2028
in 1 yr 11 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
May 26, 2028
in 2 yr
Patent 8476413 expires
Listed drug substance patent expiration.
May 29, 2028
in 2 yr
Patent 8217156 expires
Listed drug substance patent expiration.
Oct 07, 2030
in 4 yr 4 mo
Pharmaceutical detail
Active ingredient
SOTAGLIFLOZIN
Strength
200MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 216203
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)
- NCENew chemical entity exclusivity (5 years)
May 26, 2028
in 2 yr
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7781577 | May 04, 2028 | in 1 yr 11 mo | SubstanceProductU-3628 |
| 8476413 | May 29, 2028 | in 2 yr | SubstanceProductU-3628 |
| 8217156 | Oct 07, 2030 | in 4 yr 4 mo | SubstanceProduct |
