cliffwatch

lumateperone tosylate · Intra-Cellular · NDA 209500

Caplyta

Earliest generic entry, as listed · earliest of 3 marketed strengths
10 Dec 2040

Blocked by patent: US 12122792, US 12122792, US 12122792, US 12410195.

Listed patents · 40 unexpired

PatentClaimsExpires
US 12122792product, use U-401910 Dec 2040
US 12122792product, use U-402010 Dec 2040
US 12122792product, use U-434010 Dec 2040
US 12410195product10 Dec 2040
US 12090155product, use U-40007 Jul 2040
US 11980617use U-434227 Oct 2039
US 11980617use U-394027 Oct 2039
US 10695345product, use U-81430 Aug 2039
US 10695345product, use U-54330 Aug 2039
US 11052084product, use U-336330 Aug 2039
US 11052084product, use U-336230 Aug 2039
US 11052084product, use U-434130 Aug 2039
US 11690842product, use U-336330 Aug 2039
US 11690842product, use U-336230 Aug 2039
US 11690842product, use U-434130 Aug 2039
US 11806348product, use U-336330 Aug 2039
US 11806348product, use U-336230 Aug 2039
US 11806348product, use U-434130 Aug 2039
US 12070459product, use U-434130 Aug 2039
US 12070459product, use U-336230 Aug 2039
US 12070459product, use U-336330 Aug 2039
US 12128043product, use U-336330 Aug 2039
US 12128043product, use U-336230 Aug 2039
US 12409176use U-426115 Mar 2039
US 10960009use U-8143 Dec 2034
US 11026951use U-32743 Dec 2034
US 11026951use U-33643 Dec 2034
US 9956227use U-27143 Dec 2034
US RE48839use U-434419 Aug 2033
US RE48839use U-327119 Aug 2033
US RE48839use U-81419 Aug 2033
US 8648077substance, product1 Dec 2029
US 10117867use U-327127 May 2029
US 9168258product27 May 2029
US 9616061product27 May 2029
US 9199995use U-271312 Mar 2029
US 9199995use U-434312 Mar 2029
US 9586960substance, product12 Mar 2029
US RE48825substance12 Mar 2029
US 10464938product12 Mar 2028

Exclusivities · 2 unexpired

M-319miscellaneous (3 years)24 Apr 2029
I-904new indication (3 years)5 Nov 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 · 3

NDA · productFormStrengthListed expiry
209500 · 001 · RLDcapsule, oralEQ 42MG BASE10 Dec 2040
209500 · 002 · RLDcapsule, oralEQ 10.5MG BASE10 Dec 2040
209500 · 003 · RLDcapsule, oralEQ 21MG BASE10 Dec 2040
Expired or delisted (2)
  • US 11753419 · product · 10 Dec 2040 · delisted
  • US 8598119 · use U-543 · 28 Dec 2029 · delisted