Generic Caplyta Availability

Last updated on Nov 6, 2024.

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.

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
  ✓
  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
  ✓
  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
  ✓
  Patent use: TREATMENT OF SCHIZOPHRENIA
  ✓
  Drug product
- August 30, 2039
  ✓
  Patent use: TREATMENT OF SCHIZOPHRENIA
  ✓
  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
  ✓
  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
  ✓
  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
  ✓
  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
Patent 11,690,842
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
Patent 11,753,419
Patent expiration dates:
- December 10, 2040
  ✓
  Drug product
Patent 11,806,348
Patent expiration dates:
- 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
- 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
Patent 11,980,617
Patent expiration dates:
- October 27, 2039
  ✓
  Patent use: TREATMENT OF BIPOLAR DISORDER OR BIPOLAR DEPRESSION, INCLUDING ASSOCIATED DEPRESSIVE EPISODES
Patent 12,070,459
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
Patent 12,090,155
Patent expiration dates:
- July 7, 2040
  ✓
  Patent use: TREATMENT OF DEPRESSIVE EPISODES OR MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR II DISORDER
  ✓
  Drug product
Patent 12,122,792
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
  ✓
  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
  ✓
  Drug product
Patent 12,128,043
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
  ✓
  Drug substance
  ✓
  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
  ✓
  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
  ✓
  Drug substance
  ✓
  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
  ✓
  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:
- February 12, 2029
  ✓
  Drug substance
- March 12, 2029
  ✓
  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
  ✓
  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

More about Caplyta (lumateperone)

Patient resources

Caplyta drug information

Professional resources

Related treatment guides

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.

Medical Disclaimer

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

User Reviews & Ratings

6.5 / 10

173 Reviews

Images

Pill ITI-007 42 mg is Caplyta 42 mg — Caplyta 42 mg (ITI-007 42 mg)