esketamine hydrochloride · Janssen Pharms · NDA 211243

Spravato

Earliest generic entry, as listed
18 Feb 2040

Blocked by patent: US 11883526, US 11883526, US 11883526. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 25 unexpired

PatentClaimsExpires
US 11883526use U-412018 Feb 2040
US 11883526use U-381218 Feb 2040
US 11883526use U-381318 Feb 2040
US 10869844use U-411410 Sep 2035
US 10869844use U-303610 Sep 2035
US 10869844use U-303510 Sep 2035
US 10869844use U-411310 Sep 2035
US 10869844use U-303410 Sep 2035
US 11173134use U-325710 Sep 2035
US 11173134use U-353610 Sep 2035
US 11173134use U-411510 Sep 2035
US 11311500use U-303410 Sep 2035
US 11311500use U-303510 Sep 2035
US 11311500use U-411610 Sep 2035
US 11311500use U-411710 Sep 2035
US 11311500use U-303610 Sep 2035
US 11446260use U-411914 Mar 2034
US 11446260use U-411814 Mar 2034
US 11446260use U-344414 Mar 2034
US 11446260use U-344514 Mar 2034
US 11446260use U-344614 Mar 2034
US 8785500use U-25025 Mar 2033
US 8785500use U-41125 Mar 2033
US 9592207use U-250220 Mar 2027
US 9592207use U-411220 Mar 2027

Exclusivities · 1 unexpired

I-959new 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 · productFormStrengthListed expiry
211243 · 001 · RLDspray, nasalEQ 28MG BASE18 Feb 2040