sodium nitrite · Hope Pharms · NDA 203922
Sodium Nitrite
Earliest generic entry, as listed
24 Dec 2031
Blocked by patent: US 8568793.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8568793 | substance, product | 24 Dec 2031 |
| US 9687506 | product, use U-3394 | 10 Feb 2030 |
| US 9687506 | 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 |
|---|---|---|---|
| 203922 · 001 · RLD | solution, intravenous | 300MG/10ML (30MG/ML) | 24 Dec 2031 |