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Generic Caplyta Availability

Last updated on Sep 8, 2022.

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]

Has a generic version of Caplyta been approved?

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
    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
      ✓ 
      Patent use: TREATMENT OF BIPOLAR DEPRESSION
  • Patent 10,464,938

    Patent expiration dates:

    • March 12, 2028
      ✓ 
      Drug product
  • Patent 10,695,345

    Patent expiration dates:

    • August 30, 2039
      ✓ 
      Patent use: TREATMENT OF SCHIZOPHRENIA
      ✓ 
      Drug product
    • August 30, 2039
      ✓ 
      Patent use: TREATMENT OF SCHIZOPHRENIA
      ✓ 
      Drug product
  • Patent 10,960,009

    Patent expiration dates:

    • December 3, 2034
      ✓ 
      Patent use: TREATMENT OF SCHIZOPHRENIA
  • Patent 11,026,951

    Patent expiration dates:

    • December 3, 2034
      ✓ 
      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
  • Patent 11,052,084

    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
    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
  • 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
    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
      ✓ 
      Drug substance
      ✓ 
      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
    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
      ✓ 
      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
    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
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Methods and compositions for sleep disorders and other disorders
    Patent 9,616,061
    Issued: April 11, 2017
    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
    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
      ✓ 
      Patent use: TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN RESIDUAL SYMPTOMS OF SCHIZOPHRENIA
  • Patent RE48825

    Patent expiration dates:

    • February 12, 2029
      ✓ 
      Drug substance
    • March 12, 2029
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Patent RE48839

    Patent expiration dates:

    • December 28, 2029
      ✓ 
      Patent use: TREATMENT OF BIPOLAR DEPRESSION
    • December 28, 2029
      ✓ 
      Patent use: TREATMENT OF SCHIZOPHRENIA

Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:

    • December 17, 2024 - 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
    • December 20, 2024 - NEW CHEMICAL ENTITY

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.

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