naloxone hydrochloride · Kaleo Inc · NDA 215457
Naloxone Hydrochloride (Autoinjector)
Earliest generic entry, as listed
24 May 2031
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 10143792. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10143792 | use U-2476 · sets the listed date | 24 May 2031 |
| US 10322239 | use U-1907 | 28 Feb 2031 |
| US 8939943 | drug product | 28 Feb 2031 |
| US 9022022 | drug product | 28 Feb 2031 |
| US 9474869 | drug product, use U-1907 | 28 Feb 2031 |
| US 9814838 | drug product | 28 Feb 2031 |
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 |
|---|---|---|---|
| 215457 · 001 · RLD · discontinued | solution, intramuscular, subcutaneous | 10MG/0.4ML (10MG/0.4ML) | 24 May 2031 |