Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

AstraZeneca
Boehringer Ingelheim
Baxter
Express Scripts
Harvard Business School
McKesson

Last Updated: September 25, 2022

CAPLYTA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


DrugPatentWatch® Generic Entry Outlook for Caplyta

Caplyta will be eligible for patent challenges on December 20, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 30, 2039. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

< Available with Subscription >

  Try it Free

Drug patent expirations by year for CAPLYTA
Drug Prices for CAPLYTA

See drug prices for CAPLYTA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for CAPLYTA
Generic Entry Date for CAPLYTA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CAPLYTA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of ChicagoPhase 2
Intra-Cellular Therapies, Inc.Phase 2

See all CAPLYTA clinical trials

Pharmacology for CAPLYTA
Anatomical Therapeutic Chemical (ATC) Classes for CAPLYTA

US Patents and Regulatory Information for CAPLYTA

CAPLYTA is protected by eighteen US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of CAPLYTA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting CAPLYTA

Methods and compositions for sleep disorders and other disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BIPOLAR DEPRESSION

Pharmaceutical compositions comprising ((6bR,10aS)-1-(4-fluorophenyl)-4-(3-methyl-2,3,6b,9,10,10a-hexahydro-1H-p- yrido[3',4':4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)butan-1-one or pharmaceutically acceptable salts thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA

Methods of treating schizophrenia and depression
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA

Methods of treating bipolar disorder
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BIPOLAR DISORDER I, BIPOLAR DISORDER II, OR BIPOLAR DEPRESSION

Methods of treating bipolar disorder
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BIPOLAR I DISORDER, BIPOLAR II DISORDER, OR BIPOLAR DEPRESSION

Pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BIPOLAR DEPRESSION MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS

Pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS

Methods and compositions for sleep disorders and other disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA

4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3',4':4,5]pyrro- lo[1,2,3-de]quinoxalin-8(7H)-yl)-1-(4-fluorophenyl)-1-butanone toluenesulfonic acid addition salt and salt crystals
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3',4':4,5]pyrro- lo[1,2,3-de]quinoxalin-8(7H)-yl)-1-(4-fluorophenyl)-1-butanone toluenesulfonic acid addition salt and salt crystals
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MODULATION OF 5-HYDROXYTRYPTAMINE 2 RECEPTOR ACTIVITY IN SCHIZOPHRENIA

4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3',4':4,5]pyrro- lo[1,2,3-de] quinoxalin-8(7H)-yl)-1-(4-fluorophenyl)-1-butanone toluenesulfonic acid salt crystal forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods and compositions for sleep disorders and other disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method for the treatment of residual symptoms of schizophrenia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN RESIDUAL SYMPTOMS OF SCHIZOPHRENIA

4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3',4':4,5]pyrro- lo[1,2,3-de]quinoxalin-8(7H)-yl)-1-(4-fluorophenyl)-1-butanone toluenesulfonic acid salt crystal forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3',4':4,5]pyrro- lo[1,2,3-de]quinoxalin-8(7H)-yl)-1-(4-fluorophenyl)-1-butanone toluenesulfonic acid salt crystal forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods and compositions for sleep disorders and other disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BIPOLAR DEPRESSION

Methods and compositions for sleep disorders and other disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA

FDA Regulatory Exclusivity protecting CAPLYTA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

INDICATED FOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I OR II DISORDER (BIPOLAR DEPRESSION) IN ADULTS, AS MONOTHERAPY AND AS ADJUNCTIVE THERAPY WITH LITHIUM OR VALPROATE
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-001 Dec 20, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-001 Dec 20, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-003 Apr 22, 2022 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-001 Dec 20, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-001 Dec 20, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-002 Apr 22, 2022 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-003 Apr 22, 2022 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for CAPLYTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-001 Dec 20, 2019 See Plans and Pricing See Plans and Pricing
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-001 Dec 20, 2019 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for CAPLYTA

When does loss-of-exclusivity occur for CAPLYTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 19331490
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2021003838
Estimated Expiration: See Plans and Pricing

Canada

Patent: 08558
Estimated Expiration: See Plans and Pricing

China

Patent: 2584838
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 43739
Estimated Expiration: See Plans and Pricing

Israel

Patent: 0913
Estimated Expiration: See Plans and Pricing

Japan

Patent: 21535151
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 210052472
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering CAPLYTA around the world.

Country Patent Number Title Estimated Expiration
South Korea 20210049199 신규한 방법 (NOVEL METHODS) See Plans and Pricing
South Korea 101981840 See Plans and Pricing
Brazil 112021003838 métodos novos See Plans and Pricing
Canada 2374239 See Plans and Pricing
South Korea 20190083009 치환된 헤테로환 융합 감마-카르볼린 합성 (- SUBSTITUTED HETEROCYCLE FUSED GAMMA-CARBOLINES SYNTHESIS) See Plans and Pricing
South Korea 20100122948 SUBSTITUTED HETEROCYCLE FUSED GAMMA-CARBOLINES SOLID See Plans and Pricing
South Korea 20150140418 치환된 헤테로사이클 융합 감마-카볼라인 고체 (SUBSTITUTED HETEROCYCLE FUSED GAMMA-CARBOLINES SOLID) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
Merck
AstraZeneca
Dow
Boehringer Ingelheim
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.