Generic Caplyta Availability

Last updated on Jul 9, 2025.

Caplyta is a brand name of lumateperone, approved by the FDA in the following formulation(s):

CAPLYTA (lumateperone tosylate - capsule;oral)

• 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.

• 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
    
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    Patent use: TREATMENT OF BIPOLAR DEPRESSION
• 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
    
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    Drug product
• 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
    
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    Patent use: TREATMENT OF SCHIZOPHRENIA
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    Drug product
  • August 30, 2039
    
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    Patent use: TREATMENT OF SCHIZOPHRENIA
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    Drug product
• 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
    
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    Patent use: TREATMENT OF SCHIZOPHRENIA
• 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
    
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    Patent use: TREATMENT OF BIPOLAR DISORDER I, BIPOLAR DISORDER II, OR BIPOLAR DEPRESSION
  • December 3, 2034
    
    ✓ 
    Patent use: TREATMENT OF BIPOLAR I DISORDER, BIPOLAR II DISORDER, OR BIPOLAR DEPRESSION
• 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
    
    ✓ 
    Patent use: TREATMENT OF BIPOLAR DEPRESSION MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS
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    Drug product
  • August 30, 2039
    
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    Patent use: TREATMENT OF SCHIZOPHRENIA MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS
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    Drug product
• 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
    
    ✓ 
    Patent use: TREATMENT OF BIPOLAR DEPRESSION MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS
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    Drug product
  • August 30, 2039
    
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    Patent use: TREATMENT OF SCHIZOPHRENIA MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS
    ✓ 
    Drug product
• 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
    
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    Drug product
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    Sponsor has requested patent be delisted
• 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
    
    ✓ 
    Patent use: TREATMENT OF BIPOLAR DEPRESSION MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS
    ✓ 
    Drug product
  • August 30, 2039
    
    ✓ 
    Patent use: TREATMENT OF SCHIZOPHRENIA MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS
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    Drug product
• 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
    
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    Patent use: TREATMENT OF BIPOLAR DISORDER OR BIPOLAR DEPRESSION, INCLUDING ASSOCIATED DEPRESSIVE EPISODES
• 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
    
    ✓ 
    Patent use: TREATMENT OF BIPOLAR DEPRESSION MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS
    ✓ 
    Drug product
  • August 30, 2039
    
    ✓ 
    Patent use: TREATMENT OF SCHIZOPHRENIA MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS
    ✓ 
    Drug product
• 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
    
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    Patent use: TREATMENT OF DEPRESSIVE EPISODES OR MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR II DISORDER
    ✓ 
    Drug product
• 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
    
    ✓ 
    Patent use: TREATMENT OF BIPOLAR DEPRESSION BY INHIBITING THE 5-HT2A RECEPTOR, INHIBITING THE SEROTONIN TRANSPORTER, AND/OR MODULATING DOPAMINE D2 RECEPTOR FUNCTION, OR TREATMENT OF BIPOLAR DISORDER
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    Drug product
  • December 10, 2040
    
    ✓ 
    Patent use: TREATMENT OF SCHIZOPHRENIA BY INHIBITING THE 5-HT2A RECEPTOR, INHIBITING THE SEROTONIN TRANSPORTER, AND/OR MODULATING DOPAMINE D2 RECEPTOR FUNCTION, OR TREATMENT OF SCHIZOPHRENIA
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    Drug product
• 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
    
    ✓ 
    Patent use: TREATMENT OF BIPOLAR DEPRESSION MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS
    ✓ 
    Drug product
  • August 30, 2039
    
    ✓ 
    Patent use: TREATMENT OF SCHIZOPHRENIA MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS
    ✓ 
    Drug product
• 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
    
    ✓ 
    Patent use: TREATMENT OF SCHIZOPHRENIA
    ✓ 
    Sponsor has requested patent be delisted
• 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
    
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    Drug substance
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    Drug product
• 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
    
    ✓ 
    Drug product
• 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
    
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    Patent 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]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
    
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    Drug substance
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    Drug product
• 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
    
    ✓ 
    Drug product
• 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
    
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    Patent 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]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
    
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    Drug substance
  • March 12, 2029
    
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    Drug substance
    ✓ 
    Drug product
• 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, 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:

  • August 19, 2033
    
    ✓ 
    Patent use: TREATMENT OF BIPOLAR DEPRESSION
  • August 19, 2033
    
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    Patent use: TREATMENT OF SCHIZOPHRENIA

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