CAPLYTA Drug Patent Profile
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Which patents cover Caplyta, and what generic alternatives are available?
Caplyta is a drug marketed by Intra-cellular and is included in one NDA. There are eighteen patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and forty-six patent family members in twenty countries.
The generic ingredient in CAPLYTA is lumateperone tosylate. Two suppliers are listed for this compound. Additional details are available on the lumateperone tosylate profile page.
DrugPatentWatch® Generic Entry Outlook for Caplyta
Caplyta was eligible for patent challenges on December 20, 2023.
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.
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
Summary for CAPLYTA
| International Patents: | 146 |
| US Patents: | 18 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 40 |
| Clinical Trials: | 2 |
| Patent Applications: | 21 |
| Drug Prices: | Drug price information for CAPLYTA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CAPLYTA |
| What excipients (inactive ingredients) are in CAPLYTA? | CAPLYTA excipients list |
| DailyMed Link: | CAPLYTA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CAPLYTA
*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
| Sponsor | Phase |
|---|---|
| University of New Mexico | Phase 4 |
| University of Chicago | Phase 2 |
| Intra-Cellular Therapies, Inc. | Phase 2 |
Pharmacology for CAPLYTA
| Drug Class | Atypical Antipsychotic |
Anatomical Therapeutic Chemical (ATC) Classes for CAPLYTA
Paragraph IV (Patent) Challenges for CAPLYTA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| CAPLYTA | Capsules | lumateperone tosylate | 42 mg | 209500 | 7 | 2023-12-20 |
US Patents and Regulatory Information for CAPLYTA
CAPLYTA is protected by twenty-four US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of CAPLYTA is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA
Methods of treating schizophrenia and depression
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA
Methods of treating bipolar disorder
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BIPOLAR DISORDER I, BIPOLAR DISORDER II, OR BIPOLAR DEPRESSION
Methods of treating bipolar disorder
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BIPOLAR I DISORDER, BIPOLAR II DISORDER, OR BIPOLAR DEPRESSION
Pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BIPOLAR DEPRESSION MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BIPOLAR DEPRESSION 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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods and compositions for sleep disorders and other disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods and compositions for sleep disorders and other disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Method for the treatment of residual symptoms of schizophrenia
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods and compositions for sleep disorders and other disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BIPOLAR DEPRESSION
Methods and compositions for sleep disorders and other disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA
FDA Regulatory Exclusivity protecting CAPLYTA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
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: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Intra-cellular | CAPLYTA | lumateperone tosylate | CAPSULE;ORAL | 209500-003 | Apr 22, 2022 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Intra-cellular | CAPLYTA | lumateperone tosylate | CAPSULE;ORAL | 209500-001 | Dec 20, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Intra-cellular | CAPLYTA | lumateperone tosylate | CAPSULE;ORAL | 209500-001 | Dec 20, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Intra-cellular | CAPLYTA | lumateperone tosylate | CAPSULE;ORAL | 209500-001 | Dec 20, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Intra-cellular | CAPLYTA | lumateperone tosylate | CAPSULE;ORAL | 209500-001 | Dec 20, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Intra-cellular | CAPLYTA | lumateperone tosylate | CAPSULE;ORAL | 209500-003 | Apr 22, 2022 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Intra-cellular | CAPLYTA | lumateperone tosylate | CAPSULE;ORAL | 209500-001 | Dec 20, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| >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: ⤷ Sign Up
Brazil
Patent: 2021003838
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 08558
Estimated Expiration: ⤷ Sign Up
China
Patent: 2584838
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 43739
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 0913
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 57000
Estimated Expiration: ⤷ Sign Up
Patent: 21535151
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 21002321
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 210052472
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Japan | 2003502330 | ⤷ Sign Up | |
| Brazil | 112016012781 | NOVOS MÉTODOS | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 0077001 | ⤷ Sign Up | |
| Canada | 2716730 | SOLIDE DE GAMMA-CARBOLINES FUSIONNEES A HETEROCYCLES SUBSTITUES (SUBSTITUTED HETEROCYCLE FUSED GAMMA-CARBOLINES SOLID) | ⤷ Sign Up |
| Japan | 2003502331 | ⤷ Sign Up | |
| South Korea | 20110022631 | METHODS AND COMPOSITIONS FOR SLEEP DISORDERS AND OTHER DISORDERS | ⤷ Sign Up |
| South Korea | 20190006606 | 수면 장애 및 다른 장애를 치료하기 위한 방법 및 조성물 (METHODS AND COMPOSITIONS FOR SLEEP DISORDERS AND OTHER DISORDERS) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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.
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