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Caplyta patents expiration

CAPLYTA's oppositions filed in EPO
Can you believe CAPLYTA received compensation for the extended wait time during the regulatory approval process?
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
USRE48825 INTRA-CELLULAR 4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)-1-(4-fluorophenyl)-1-butanone toluenesulfonic acid salt crystal forms
Feb, 2029

(5 years from now)

US9586960 INTRA-CELLULAR 4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de] quinoxalin-8(7H)-yl)-1-(4-fluorophenyl)-1-butanone toluenesulfonic acid salt crystal forms
Mar, 2029

(5 years from now)

US8648077 INTRA-CELLULAR 4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)-1-(4-fluorophenyl)-1-butanone toluenesulfonic acid addition salt and salt crystals
Dec, 2029

(6 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10464938 INTRA-CELLULAR Pharmaceutical compositions comprising ((6bR,10aS)-1-(4-fluorophenyl)-4-(3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)butan-1-one or pharmaceutically acceptable salts thereof
Mar, 2028

(4 years from now)

US9199995 INTRA-CELLULAR 4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)-1-(4-fluorophenyl)-1-butanone toluenesulfonic acid addition salt and salt crystals
Mar, 2029

(5 years from now)

US10117867 INTRA-CELLULAR Methods and compositions for sleep disorders and other disorders
May, 2029

(5 years from now)

US9616061 INTRA-CELLULAR Methods and compositions for sleep disorders and other disorders
May, 2029

(5 years from now)

USRE48839 INTRA-CELLULAR Methods and compositions for sleep disorders and other disorders
Dec, 2029

(6 years from now)

US8598119 INTRA-CELLULAR Methods and compositions for sleep disorders and other disorders
Dec, 2029

(6 years from now)

US10960009 INTRA-CELLULAR Methods of treating schizophrenia and depression
Dec, 2034

(11 years from now)

US9956227 INTRA-CELLULAR Method for the treatment of residual symptoms of schizophrenia
Dec, 2034

(11 years from now)

US11026951 INTRA-CELLULAR Methods of treating bipolar disorder
Dec, 2034

(11 years from now)

US11690842 INTRA-CELLULAR Pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Aug, 2039

(15 years from now)

US10695345 INTRA-CELLULAR Pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Aug, 2039

(15 years from now)

US11052084 INTRA-CELLULAR Pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Aug, 2039

(15 years from now)

Caplyta is owned by Intra-Cellular.

Caplyta contains Lumateperone Tosylate.

Caplyta has a total of 15 drug patents out of which 0 drug patents have expired.

Caplyta was authorised for market use on 20 December, 2019.

Caplyta is available in capsule;oral dosage forms.

Caplyta can be used as treatment of bipolar depression mediated by the 5-ht2a receptor, serotonin transporter, and/or dopamine d1/d2 signaling pathways; treatment of schizophrenia mediated by the 5-ht2a receptor, serotonin transporter, and/or dopamine d1/d2 signaling pathways, treatment of bipolar depression, modulation of 5-hydroxytryptamine 2 receptor activity in schizophrenia, treatment of bipolar depression; treatment of schizophrenia, treatment of schizophrenia with improvement in residual symptoms of schizophrenia, treatment of bipolar i disorder, bipolar ii disorder, or bipolar depression, treatment of schizophrenia.

Drug patent challenges can be filed against Caplyta from 2023-12-21.

The generics of Caplyta are possible to be released after 30 August, 2039.

Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity (NCE) Dec 20, 2024
New Indication (I) Dec 17, 2024

Drugs and Companies using LUMATEPERONE TOSYLATE ingredient

NCE-1 date: 2023-12-21

Market Authorisation Date: 20 December, 2019

Treatment: Modulation of 5-hydroxytryptamine 2 receptor activity in schizophrenia; Treatment of bipolar depression; Treatment of schizophrenia; Treatment of schizophrenia with improvement in residual symptoms of...

Dosage: CAPSULE;ORAL

More Information on Dosage

CAPLYTA family patents

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