esketamine hydrochloride · Janssen Pharms · NDA 211243
Spravato
Earliest generic entry, as listed
18 Feb 2040
Blocked by patent: US 11883526. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 7 unexpired
25 Orange Book listing rows for 7 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11883526 | use U-3812, U-3813, U-4120 | 18 Feb 2040 |
| US 11883526 listing row | use U-3812 · sets the listed date | 18 Feb 2040 |
| US 11883526 listing row | use U-3813 · sets the listed date | 18 Feb 2040 |
| US 11883526 listing row | use U-4120 · sets the listed date | 18 Feb 2040 |
| US 10869844 | use U-3034, U-3035, U-3036, U-4113, U-4114 | 10 Sep 2035 |
| US 10869844 listing row | use U-3034 | 10 Sep 2035 |
| US 10869844 listing row | use U-3035 | 10 Sep 2035 |
| US 10869844 listing row | use U-3036 | 10 Sep 2035 |
| US 10869844 listing row | use U-4113 | 10 Sep 2035 |
| US 10869844 listing row | use U-4114 | 10 Sep 2035 |
| US 11173134 | use U-3257, U-3536, U-4115 | 10 Sep 2035 |
| US 11173134 listing row | use U-3257 | 10 Sep 2035 |
| US 11173134 listing row | use U-3536 | 10 Sep 2035 |
| US 11173134 listing row | use U-4115 | 10 Sep 2035 |
| US 11311500 | use U-3034, U-3035, U-3036, U-4116, U-4117 | 10 Sep 2035 |
| US 11311500 listing row | use U-3034 | 10 Sep 2035 |
| US 11311500 listing row | use U-3035 | 10 Sep 2035 |
| US 11311500 listing row | use U-3036 | 10 Sep 2035 |
| US 11311500 listing row | use U-4116 | 10 Sep 2035 |
| US 11311500 listing row | use U-4117 | 10 Sep 2035 |
| US 11446260 | use U-3444, U-3445, U-3446, U-4118, U-4119 | 14 Mar 2034 |
| US 11446260 listing row | use U-3444 | 14 Mar 2034 |
| US 11446260 listing row | use U-3445 | 14 Mar 2034 |
| US 11446260 listing row | use U-3446 | 14 Mar 2034 |
| US 11446260 listing row | use U-4118 | 14 Mar 2034 |
| US 11446260 listing row | use U-4119 | 14 Mar 2034 |
| US 8785500 | use U-2502, U-4112 | 5 Mar 2033 |
| US 8785500 listing row | use U-2502 | 5 Mar 2033 |
| US 8785500 listing row | use U-4112 | 5 Mar 2033 |
| US 9592207 | use U-2502, U-4112 | 20 Mar 2027 |
| US 9592207 listing row | use U-2502 | 20 Mar 2027 |
| US 9592207 listing row | use U-4112 | 20 Mar 2027 |
Exclusivities · 1 unexpired
| I-959 | new indication (3 years) | 17 Jan 2028 |
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 |
|---|---|---|---|
| 211243 · 001 · RLD | spray, nasal | EQ 28MG BASE | 18 Feb 2040 |