FDA Orange Book
Is there a generic for Bludigo?
Bludigo contains indigotindisulfonate. 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 Bludigo (indigotindisulfonate). The Orange Book shows its last listed patent expires December 23, 2037 and its last listed exclusivity ends July 8, 2027.
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Bludigo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 40MG/5ML (8MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 216264, held by PROVEPHARM SAS. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Bludigo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11845867 | November 25, 2036 | Drug substance | None | 216264 |
| 10927258 | December 23, 2037 | Drug substance | None | 216264 |
| 11499050 | December 23, 2037 | Drug substance | None | 216264 |
Bludigo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | July 8, 2027 | 216264 |
Bludigo NDC codes
Questions
Is there a generic for Bludigo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Bludigo (indigotindisulfonate). The Orange Book shows its last listed patent expires December 23, 2037 and its last listed exclusivity ends July 8, 2027.
What is the generic name for Bludigo?
The active ingredient in Bludigo is indigotindisulfonate, per the FDA Orange Book.
When does the Bludigo patent expire?
The last patent listed for Bludigo in the Orange Book expires December 23, 2037. 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.