Caplyta Patent Expiration

Caplyta is a drug owned by Intra-cellular Therapies Inc. It is protected by 20 US drug patents filed from 2020 to 2023. Out of these, 18 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 10, 2040. Details of Caplyta's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
USRE39680 Substituted heterocycle fused gamma-carbolines
Jun, 2020

(4 years ago)

Expired
US7183282 Substituted heterocycle fused γ-carbolines
Jun, 2020

(4 years ago)

Expired
USRE48825 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
Mar, 2029

(4 years from now)

Active
US9586960 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
Mar, 2029

(4 years from now)

Active
US8648077 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
Dec, 2029

(5 years from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10464938 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
Mar, 2028

(3 years from now)

Active
US9199995 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
Mar, 2029

(4 years from now)

Active
US9168258 Methods and compositions for sleep disorders and other disorders
May, 2029

(4 years from now)

Active
US10117867 Methods and compositions for sleep disorders and other disorders
May, 2029

(4 years from now)

Active
US9616061 Methods and compositions for sleep disorders and other disorders
May, 2029

(4 years from now)

Active
US8598119 Methods and compositions for sleep disorders and other disorders
Dec, 2029

(5 years from now)

Active
USRE48839 Methods and compositions for sleep disorders and other disorders
Aug, 2033

(9 years from now)

Active
US10960009 Methods of treating schizophrenia and depression
Dec, 2034

(10 years from now)

Active
US11026951 Methods of treating bipolar disorder
Dec, 2034

(10 years from now)

Active
US9956227 Method for the treatment of residual symptoms of schizophrenia
Dec, 2034

(10 years from now)

Active
US11690842 Pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Aug, 2039

(15 years from now)

Active
US11052084 Pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Aug, 2039

(15 years from now)

Active
US10695345 Pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Aug, 2039

(15 years from now)

Active
US11806348 Methods of treatment using pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Aug, 2039

(15 years from now)

Active
US11753419 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 conditions of the central nervous system and cardiac disorders
Dec, 2040

(16 years from now)

Active


FDA has granted several exclusivities to Caplyta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Caplyta, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Caplyta.

Exclusivity Information

Caplyta holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2024. Details of Caplyta's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-882) Dec 17, 2024
New Chemical Entity Exclusivity(NCE) Dec 20, 2024

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Several oppositions have been filed on Caplyta's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Caplyta's generic, the next section provides detailed information on ongoing and past EP oppositions related to Caplyta patents.

Caplyta's oppositions filed in EPO

Caplyta has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 27, 2022, by Sandoz Ag. This opposition was filed on patent number EP14867061A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP14867061A Apr, 2022 Sandoz AG Granted and Under Opposition


US patents provide insights into the exclusivity only within the United States, but Caplyta is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Caplyta's family patents as well as insights into ongoing legal events on those patents.

Caplyta's family patents

Caplyta has patent protection in a total of 20 countries. It's US patent count contributes only to 32.5% of its total global patent coverage. Click below to unlock the full patent family tree for Caplyta.

Family Patents

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Generic Launch

Generic Release Date:

Caplyta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 10, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Caplyta Generics:

There are no approved generic versions for Caplyta as of now.





About Caplyta

Caplyta is a drug owned by Intra-Cellular Therapies Inc. It is used for treating schizophrenia, bipolar depression, and bipolar disorder by modulating serotonin and dopamine receptor activity. Caplyta uses Lumateperone Tosylate as an active ingredient. Caplyta was launched by Intra-Cellular in 2022.

Can you believe Caplyta received compensation for the extended wait time during the regulatory approval process?

A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.

Market Authorisation Date:

Caplyta was approved by FDA for market use on 22 April, 2022.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Caplyta is 22 April, 2022, its NCE-1 date is estimated to be 21 December, 2023

Active Ingredient:

Caplyta uses Lumateperone Tosylate as the active ingredient. Check out other Drugs and Companies using Lumateperone Tosylate ingredient

Treatment:

Caplyta is used for treating schizophrenia, bipolar depression, and bipolar disorder by modulating serotonin and dopamine receptor activity.

Dosage:

Caplyta is available in capsule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 42MG BASE CAPSULE Prescription ORAL
EQ 10.5MG BASE CAPSULE Prescription ORAL
EQ 21MG BASE CAPSULE Prescription ORAL