Caplyta is a drug owned by Intra-cellular Therapies Inc. It is protected by 25 US drug patents filed from 2020 to 2024. Out of these, 23 drug patents are active and 2 have expired. Caplyta's patents have been open to challenges since 21 December, 2023. 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| 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
(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 |
| 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 |
Feb, 2029
(4 years from now) | Active |
| USRE39680 | Substituted heterocycle fused gamma-carbolines |
Jun, 2020
(4 years ago) |
Expired
|
| US7183282 | Substituted heterocycle fused γ-carbolines |
Jun, 2020
(4 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| 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
(15 years from now) | Active |
| US12122792 | 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)phenyl)butan-1-one for treating conditions of the central nervous system and cardiac disorders |
Dec, 2040
(15 years from now) | Active |
| US12090155 | Methods |
Jul, 2040
(15 years from now) | Active |
| US11980617 | Methods of treating acute depression and/or acute anxiety |
Oct, 2039
(14 years from now) | Active |
| US11690842 | Pharmaceutical capsule compositions comprising lumateperone mono-tosylate |
Aug, 2039
(14 years from now) | Active |
| US11052084 | Pharmaceutical capsule compositions comprising lumateperone mono-tosylate |
Aug, 2039
(14 years from now) | Active |
| US10695345 | Pharmaceutical capsule compositions comprising lumateperone mono-tosylate |
Aug, 2039
(14 years from now) | Active |
| US12128043 | Pharmaceutical capsules comprising lumateperone mono-tosylate |
Aug, 2039
(14 years from now) | Active |
| US11806348 | Methods of treatment using pharmaceutical capsule compositions comprising lumateperone mono-tosylate |
Aug, 2039
(14 years from now) | Active |
| US12070459 | Pharmaceutical capsule compositions comprising lumateperone mono-tosylate |
Aug, 2039
(14 years from now) | Active |
| US11026951 | Methods of treating bipolar disorder |
Dec, 2034
(9 years from now) | Active |
| US9956227 | Method for the treatment of residual symptoms of schizophrenia |
Dec, 2034
(9 years from now) | Active |
| US10960009 | Methods of treating schizophrenia and depression |
Dec, 2034
(9 years from now) | Active |
| USRE48839 | Methods and compositions for sleep disorders and other disorders |
Aug, 2033
(8 years from now) | Active |
| US8598119 | Methods and compositions for sleep disorders and other disorders |
Dec, 2029
(5 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 |
| 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 |
| 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 |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Caplyta's patents.
Latest Legal Activities on Caplyta's Patents
Given below is the list of recent legal activities going on the following patents of Caplyta.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent eCofC Notification | 30 Jan, 2024 | US11806348 |
| Email Notification Critical | 30 Jan, 2024 | US11806348 |
| Mail Patent eCofC Notification | 30 Jan, 2024 | US11806348 |
| Recordation of Patent eCertificate of Correction | 30 Jan, 2024 | US11806348 |
| Post Issue Communication - Certificate of Correction | 10 Jan, 2024 | US11806348 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 30 Nov, 2023 | US10695345 |
| Recordation of Patent Grant Mailed Critical | 07 Nov, 2023 | US11806348 |
| Mail Patent eGrant Notification | 07 Nov, 2023 | US11806348 |
| Patent eGrant Notification | 07 Nov, 2023 | US11806348 |
| Email Notification Critical | 07 Nov, 2023 | US11806348 |
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. All of its exclusivities have expired 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 |
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 |
|---|---|---|---|
 | |||
| 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
Explore Our Curated Drug Screens
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.
Alternative Brands for Caplyta
Caplyta which is used for treating schizophrenia, bipolar depression, and bipolar disorder by modulating serotonin and dopamine receptor activity., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Alkermes Inc |
| |||||||||
| Astrazeneca |
| |||||||||
| Indivior |
| |||||||||
| Janssen Pharms |
| |||||||||
| Otsuka |
| |||||||||
| Otsuka Pharm Co Ltd |
| |||||||||
| Sunovion Pharms Inc |
| |||||||||
| Teva |
| |||||||||
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.
Approval Date:
Caplyta was approved by FDA for market use on 22 April, 2022.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. 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 10.5MG BASE | CAPSULE | Prescription | ORAL |
| EQ 42MG BASE | CAPSULE | Prescription | ORAL |
| EQ 21MG BASE | CAPSULE | Prescription | ORAL |