indigotindisulfonate sodium · Provepharm Sas · NDA 216264
Bludigo
Earliest generic entry, as listed
23 Dec 2037
Blocked by patent: US 10927258, US 11499050.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10927258 | substance | 23 Dec 2037 |
| US 11499050 | substance | 23 Dec 2037 |
| US 11845867 | substance | 25 Nov 2036 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 8 Jul 2027 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 216264 · 001 · RLD | solution, intravenous | 40MG/5ML (8MG/ML) | 23 Dec 2037 |