Orange Book product · Brand (NDA)
BLUDIGO
INDIGOTINDISULFONATE SODIUM
At a glance
Jul 08, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 08, 2022
4 yr ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jul 08, 2027
in 1 yr 1 mo
Patent 11845867 expires
Listed drug substance patent expiration.
Nov 25, 2036
in 10 yr 7 mo
Patent 10927258 expires
Listed drug substance patent expiration.
Dec 23, 2037
in 11 yr 8 mo
Patent 11499050 expires
Listed drug substance patent expiration.
Dec 23, 2037
in 11 yr 8 mo
Pharmaceutical detail
Active ingredient
INDIGOTINDISULFONATE SODIUM
Strength
40MG/5ML (8MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 216264
Product number
001
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)
- NCENew chemical entity exclusivity (5 years)
Jul 08, 2027
in 1 yr 1 mo
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11845867 | Nov 25, 2036 | in 10 yr 7 mo | Substance |
| 10927258 | Dec 23, 2037 | in 11 yr 8 mo | Substance |
| 11499050 | Dec 23, 2037 | in 11 yr 8 mo | Substance |
