naloxone hydrochloride · Kaleo Inc · NDA 209862
Evzio (Autoinjector)
Earliest generic entry, as listed
20 Mar 2035
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 10220158.
Listed patents · 17 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10220158 | drug product, use U-2500 · sets the listed date | 20 Mar 2035 |
| US 9517307 | drug product, use U-1925 | 18 Jul 2034 |
| US 8627816 | drug product | 4 Feb 2032 |
| US 10143792 | use U-2476 | 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 8021344 | drug product | 2 Nov 2029 |
| US 8226610 | drug product | 10 Apr 2029 |
| US 8231573 | drug product | 25 Nov 2028 |
| US 7749194 | drug product | 30 Oct 2028 |
| US 7947017 | drug product | 12 Mar 2028 |
| US 9724471 | drug product, use U-2092 | 23 May 2027 |
| US 8206360 | drug product | 27 Feb 2027 |
| US 9238108 | drug product | 20 Feb 2027 |
| US 11590286 | drug product | 12 Dec 2026 |
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 |
|---|---|---|---|
| 209862 · 001 · RLD · discontinued | solution, intramuscular, subcutaneous | 2MG/0.4ML (2MG/0.4ML) | 20 Mar 2035 |
Expired or delisted (4)
- US 10960155 · product · 25 Jun 2026
- US 7731686 · product · 1 Jun 2026
- US 8926594 · product · 31 Mar 2026
- US 9278182 · product · 1 Feb 2026