sodium nitrite; sodium thiosulfate · Hope Pharms · NDA 201444
Nithiodote
Earliest generic entry, as listed
24 Dec 2031
Blocked by patent: US 8568793.
Listed patents · 8 unexpired
9 Orange Book listing rows for 8 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8568793 | drug substance, drug product · sets the listed date | 24 Dec 2031 |
| US 8496973 | drug substance, drug product, use U-1419 | 29 Mar 2031 |
| US 10479686 | drug product, use U-3390 | 7 Jul 2030 |
| US 9345724 | drug substance, drug product, use U-2015 | 7 Jul 2030 |
| US 9585912 | drug substance, drug product | 7 Jul 2030 |
| US 11753301 | drug substance, drug product, use U-3681 | 10 Feb 2030 |
| US 12304813 | drug product | 10 Feb 2030 |
| US 9687506 | drug product, use U-3394, U-3395 | 10 Feb 2030 |
| US 9687506 listing row | drug product, use U-3394 | 10 Feb 2030 |
| US 9687506 listing row | drug product, use U-3395 | 10 Feb 2030 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
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 |
|---|---|---|---|
| 201444 · 001 · RLD | solution, solution, intravenous, intravenous | 300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML) | 24 Dec 2031 |