Generic Caplyta Availability
Last updated on Jun 11, 2025.
Caplyta is a brand name of lumateperone, approved by the FDA in the following formulation(s):
CAPLYTA (lumateperone tosylate - capsule;oral)
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Manufacturer: INTRA-CELLULAR
Approval date: December 20, 2019
Strength(s): EQ 42MG BASE [RLD] -
Manufacturer: INTRA-CELLULAR
Approval date: April 22, 2022
Strength(s): EQ 10.5MG BASE [RLD], EQ 21MG BASE [RLD]
Is there a generic version of Caplyta available?
No. There is currently no therapeutically equivalent version of Caplyta available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Caplyta. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Methods and compositions for sleep disorders and other disorders
Patent 10,117,867
Issued: November 6, 2018
Inventor(s): Mates Sharon & Fienberg Allen & Wennogle Lawrence P.
Assignee(s): INTRA-CELLULAR THERAPIES, INC.Use of particular substituted heterocycle fused gamma-carboline compounds as pharmaceuticals and pharmaceutical compositions comprising them for the treatment of one or more disorders involving the 5-HT2A, SERT and/or dopamine D2 pathways are disclosed. In addition, the compounds may be combined with other therapeutic agents for the treatment of one or more sleep disorders, depression, psychosis, dyskinesias, and/or Parkinson's disease or any combinations.
Patent expiration dates:
- May 27, 2029✓
- May 27, 2029
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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
Patent 10,464,938
Issued: November 5, 2019
Inventor(s): Tomesch John Charles & Li Peng & Yao Wei & Zhang Qiang & Beard James David & Thompson Andrew S. & Cheng Hua & Wennogle Lawrence P.
Assignee(s): INTRA-CELLULAR THERAPIES, INC.The present invention provides pharmaceutical compositions comprising certain optionally substituted heterocycle fused gamma-carbolines of Formula 2J, as shown below, and as further defined herein:
Patent expiration dates:
- March 12, 2028✓
- March 12, 2028
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Pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Patent 10,695,345
Issued: June 30, 2020
Inventor(s): Li Peng & Davis Robert
Assignee(s): INTRA-CELLULAR THERAPIES, INC.The present disclosure relates to pharmaceutical capsules comprising lumateperone, in free, or pharmaceutically acceptable salt form, optionally in combination with one or more additional therapeutic agents, processes for manufacture thereof and methods of use in the treatment or prophylaxis of disease.
Patent expiration dates:
- August 30, 2039✓✓
- August 30, 2039✓✓
- August 30, 2039
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Methods of treating schizophrenia and depression
Patent 10,960,009
Issued: March 30, 2021
Inventor(s): Vanover Kimberly & Li Peng & Mates Sharon & Davis Robert & Wennogle Lawrence P.
Assignee(s): INTRA-CELLULAR THERAPIES, INC.The disclosure provides the use of particular substituted heterocycle fused gamma-carboline compounds as pharmaceuticals for the treatment of residual symptoms of psychosis or schizophrenia. The disclosure also provides novel long acting injectable formulations of particular substituted heterocycle fused gamma-carboline compounds and use of such long acting injectable formulations for the treatment of residual symptoms of psychosis or schizophrenia.
Patent expiration dates:
- December 3, 2034✓
- December 3, 2034
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Methods of treating bipolar disorder
Patent 11,026,951
Issued: June 8, 2021
Inventor(s): Vanover Kimberly & Li Peng & Mates Sharon & Davis Robert & Wennogle Lawrence P.
Assignee(s): INTRA-CELLULAR THERAPIES, INC.The disclosure provides the use of particular substituted heterocycle fused gamma-carboline compounds as pharmaceuticals for the treatment of residual symptoms of psychosis or schizophrenia. The disclosure also provides novel long acting injectable formulations of particular substituted heterocycle fused gamma-carboline compounds and use of such long acting injectable formulations for the treatment of residual symptoms of psychosis or schizophrenia.
Patent expiration dates:
- December 3, 2034✓
- December 3, 2034✓
- December 3, 2034
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Pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Patent 11,052,084
Issued: July 6, 2021
Inventor(s): Li Peng & Davis Robert
Assignee(s): INTRA-CELLULAR THERAPIES, INC.The present disclosure relates to pharmaceutical capsules comprising lumateperone, in free, or pharmaceutically acceptable salt form, optionally in combination with one or more additional therapeutic agents, processes for manufacture thereof and methods of use in the treatment or prophylaxis of disease.
Patent expiration dates:
- August 30, 2039✓✓
- August 30, 2039✓✓
- August 30, 2039
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Pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Patent 11,690,842
Issued: July 4, 2023
Inventor(s): Li; Peng et al.
Assignee(s): INTRA-CELLULAR THERAPIES, INC. (New York, NY)The present disclosure relates to pharmaceutical capsules comprising lumateperone, in free, or pharmaceutically acceptable salt form, optionally in combination with one or more additional therapeutic agents, processes for manufacture thereof and methods of use in the treatment or prophylaxis of disease.
Patent expiration dates:
- August 30, 2039✓✓
- August 30, 2039✓✓
- August 30, 2039
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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-((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)phenyl)butan-1-one for treating conditio
Patent 11,753,419
Issued: September 12, 2023
Inventor(s): Li; Peng et al.
Assignee(s): INTRA-CELLULAR THERAPIES, INC. (New York, NY)The invention relates to a particular substituted heterocycle fused gamma carboline, the compound of Formula I, ##STR00001##
and new methods and uses pertaining thereto, and pharmaceutical compositions thereof, such as methods of use in the treatment of diseases involving the 5-HT receptor, the serotonin transporter (SERT), and/or pathways involving dopamine D.sub.2 receptor signaling, sodium channel activity, and/or norepinephrine transporter activity.Patent expiration dates:
- December 10, 2040✓
- December 10, 2040
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Methods of treatment using pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Patent 11,806,348
Issued: November 7, 2023
Inventor(s): Li; Peng et al.
Assignee(s): INTRA-CELLULAR THERAPIES, INC. (New York, NY)The present disclosure relates to pharmaceutical capsules comprising lumateperone, in free, or pharmaceutically acceptable salt form, optionally in combination with one or more additional therapeutic agents, processes for manufacture thereof and methods of use in the treatment or prophylaxis of disease.
Patent expiration dates:
- August 30, 2039✓✓
- August 30, 2039✓✓
- August 30, 2039
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Methods of treating acute depression and/or acute anxiety
Patent 11,980,617
Issued: May 14, 2024
Inventor(s): Snyder; Gretchen et al.
Assignee(s): INTRA-CELLULAR THERAPIES, INC. (New York, NY)The disclosure provides methods for the acute treatment of depression and/or anxiety, for the enhancement of mTOR (e.g., mTORC1) signaling, and for the reduction of neuroinflammation, comprising administering to a patient in need thereof, a therapeutically effective amount of a 5-HT2A or 5-HT2A/D2 receptor ligand, e.g. lumateperone.
Patent expiration dates:
- October 27, 2039✓
- October 27, 2039
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Pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Patent 12,070,459
Issued: August 27, 2024
Inventor(s): Li; Peng et al.
Assignee(s): INTRA-CELLULAR THERAPIES, INC. (New York, NY)The present disclosure relates to pharmaceutical capsules comprising lumateperone, in free, or pharmaceutically acceptable salt form, optionally in combination with one or more additional therapeutic agents, processes for manufacture thereof and methods of use in the treatment or prophylaxis of disease.
Patent expiration dates:
- August 30, 2039✓✓
- August 30, 2039✓✓
- August 30, 2039
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Methods
Patent 12,090,155
Issued: September 17, 2024
Inventor(s): Mates; Sharon et al.
Assignee(s): INTRA-CELLULAR THERAPIES, INC. (New York, NY)The disclosure provides methods for the treatment of Bipolar II Disorder, comprising administering to a patient in need thereof, a therapeutically effective amount of lumateperone, in free or pharmaceutically acceptable salt form, optionally in deuterated form.
Patent expiration dates:
- July 7, 2040✓✓
- July 7, 2040
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Pharmaceutical compositions comprising 4-((6bR,10aS)-3-methyl2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin8(7H)-yl)-1-(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)ph
Patent 12,122,792
Issued: October 22, 2024
Inventor(s): Li; Peng et al.
Assignee(s): INTRA-CELLULAR THERAPIES, INC. (New York, NY)The invention relates to pharmaceutical compositions comprising the compound of Formula I, ##STR00001##
and new methods and uses pertaining thereto, and pharmaceutical compositions thereof, such as methods of use in the treatment of diseases involving the 5-HT receptor, the serotonin transporter (SERT), and/or pathways involving dopamine D.sub.2 receptor signaling, sodium channel activity, and/or norepinephrine transporter activity.Patent expiration dates:
- December 10, 2040✓✓
- December 10, 2040✓✓
- December 10, 2040
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Pharmaceutical capsules comprising lumateperone mono-tosylate
Patent 12,128,043
Issued: October 29, 2024
Inventor(s): Li; Peng et al.
Assignee(s): INTRA-CELLULAR THERAPIES, INC. (New York, NY)The present disclosure relates to pharmaceutical capsules comprising lumateperone, in free, or pharmaceutically acceptable salt form, optionally in combination with one or more additional therapeutic agents, processes for manufacture thereof and methods of use in the treatment or prophylaxis of disease.
Patent expiration dates:
- August 30, 2039✓✓
- August 30, 2039✓✓
- August 30, 2039
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Methods and compositions for sleep disorders and other disorders
Patent 8,598,119
Issued: December 3, 2013
Inventor(s): Mates Sharon & Fienberg Allen & Wennogle Lawrence
Assignee(s): Intra-Cellular Therapies, Inc.Use of particular substituted heterocycle fused gamma-carboline compounds as pharmaceuticals and pharmaceutical compositions comprising them for the treatment of one or more disorders involving the 5-HT2A, SERT and/or dopamine D2 pathways are disclosed. In addition, the compounds may be combined with other therapeutic agents for the treatment of one or more sleep disorders, depression, psychosis, dyskinesias, and/or Parkinson's disease or any combinations.
Patent expiration dates:
- December 28, 2029✓✓
- December 28, 2029
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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
Patent 8,648,077
Issued: February 11, 2014
Inventor(s): Tomesch John & Wennogle Lawrence P.
Assignee(s): Intra-Cellular Therapies, Inc.The present invention relates to toluenesulfonic acid addition salt crystals of 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, the method of making and using such crystals.
Patent expiration dates:
- December 1, 2029✓✓
- December 1, 2029
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Methods and compositions for sleep disorders and other disorders
Patent 9,168,258
Issued: October 27, 2015
Inventor(s): Mates Sharon & Fienberg Allen & Wennogle Lawrence P.
Assignee(s): INTRA-CELLULAR THERAPRIES, INC.Use of particular substituted heterocycle fused gamma-carboline compounds as pharmaceuticals and pharmaceutical compositions comprising them for the treatment of one or more disorders involving the 5-HT2A, SERT and/or dopamine D2 pathways are disclosed. In addition, the compounds may be combined with other therapeutic agents for the treatment of one or more sleep disorders, depression, psychosis, dyskinesias, and/or Parkinson's disease or any combinations.
Patent expiration dates:
- May 27, 2029✓
- May 27, 2029
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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
Patent 9,199,995
Issued: December 1, 2015
Inventor(s): Tomesch John & Wennogle Lawrence P.
Assignee(s): INTRA-CELLULAR THERAPIES, INC.The present invention relates to 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 tosylate salt in crystalline and in solid forms, the method of making and using such crystals.
Patent expiration dates:
- March 12, 2029✓
- March 12, 2029
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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
Patent 9,586,960
Issued: March 7, 2017
Inventor(s): Tomesch John & Wennogle Lawrence P.
Assignee(s): INTRA-CELLULAR THERAPIES, INC.The present invention relates to toluenesulfonic acid addition salt crystals of 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, and methods of using such crystals as 5-hydroxytryptamine 2 receptor agonists and antagonists in treating disorders of the central nervous system.
Patent expiration dates:
- March 12, 2029✓✓
- March 12, 2029
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Methods and compositions for sleep disorders and other disorders
Patent 9,616,061
Issued: April 11, 2017
Inventor(s): Mates Sharon & Fienberg Allen & Wennogle Lawrence
Assignee(s): INTRA-CELLULAR THERAPIES, INC.Use of particular substituted heterocycle fused gamma-carboline compounds as pharmaceuticals and pharmaceutical compositions comprising them for the treatment of one or more disorders involving the 5-HT2A, SERT and/or dopamine D2 pathways are disclosed. In addition, the compounds may be combined with other therapeutic agents for the treatment of one or more sleep disorders, depression, psychosis, dyskinesias, and/or Parkinson's disease or any combinations.
Patent expiration dates:
- May 27, 2029✓
- May 27, 2029
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Method for the treatment of residual symptoms of schizophrenia
Patent 9,956,227
Issued: May 1, 2018
Inventor(s): Vanover Kimberly & Li Peng & Mates Sharon & Davis Robert & Wennogle Lawrence P.
Assignee(s): INTRA-CELLULAR THERAPIES, INC.The disclosure provides the use of particular substituted heterocycle fused gamma-carboline compounds as pharmaceuticals for the treatment of residual symptoms of psychosis or schizophrenia. The disclosure also provides novel long acting injectable formulations of particular substituted heterocycle fused gamma-carboline compounds and use of such long acting injectable formulations for the treatment of residual symptoms of psychosis or schizophrenia.
Patent expiration dates:
- December 3, 2034✓
- December 3, 2034
-
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
Patent RE48825
Issued: November 23, 2021
Inventor(s): Tomesch John & Wennogle Lawrence P.
Assignee(s): INTRA-CELLULAR THERAPIES, INC.The present invention relates to toluenesulfonic acid addition salt crystals of 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, and methods of using such crystals as 5-hydroxytryptamine 2 receptor agonists and antagonists in treating disorders of the central nervous system.
Patent expiration dates:
- March 12, 2029✓
- March 12, 2029✓✓
- March 12, 2029
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Methods and compositions for sleep disorders and other disorders
Patent RE48839
Issued: December 7, 2021
Inventor(s): Mates Sharon & Fienberg Allen & Wennogle Lawrence
Assignee(s): Intra-Cellular Therapies, IncUse of particular substituted heterocycle fused gamma-carboline compounds as pharmaceuticals and pharmaceutical compositions comprising them for the treatment of one or more disorders involving the 5-HT2A, SERT and/or dopamine D2 pathways are disclosed. In addition, the compounds may be combined with other therapeutic agents for the treatment of one or more sleep disorders, depression, psychosis, dyskinesias, and/or Parkinson's disease or any combinations.
Patent expiration dates:
- August 19, 2033✓
- August 19, 2033✓
- August 19, 2033
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Glossary
Term | Definition |
---|---|
Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.