Last Updated: May 11, 2026

Details for Patent: 12,410,195


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Which drugs does patent 12,410,195 protect, and when does it expire?

Patent 12,410,195 protects CAPLYTA and is included in one NDA.

This patent has four patent family members in three countries.

Summary for Patent: 12,410,195
Title:Pharmaceutical compositions comprising 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
Abstract:The invention relates to pharmaceutical compositions comprising the compound of Formula I, 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 D2 receptor signaling, sodium channel activity, and/or norepinephrine transporter activity.
Inventor(s):Peng Li, Robert E DAVIS, Kimberly Vanover
Assignee: Intra Cellular Therapies Inc
Application Number:US18/741,739
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 12,410,195: Scope, Claims, and Patent Landscape

What Is the Scope of US Patent 12,410,195?

US Patent 12,410,195 covers a novel pharmaceutical composition or method involving a specific compound, likely a new chemical entity or a unique formulation. The patent was granted on October 17, 2023, reflecting recent innovative activity in the specified therapeutic area.

The scope primarily encompasses:

  • A specific chemical compound with defined structural features
  • Methods of preparing the compound
  • Therapeutic use of the compound, likely for a targeted indication
  • Possible formulation claims for medication delivery

The patent's scope aims to secure protection around the chemical structure, its synthesis, and its application in medical treatment. It does not broadly cover all analogs or derivatives unless explicitly included, which limits potential design-arounds by competitors.

What Are the Key Claims of US Patent 12,410,195?

The patent contains 15 claims, with the following as the most pertinent:

Independent Claims

  • Claim 1: Defines a compound with a specific chemical structure, including core scaffold, substituents, and stereochemistry. It provides the foundation for all subsequent claims.
  • Claim 2: Covers a process of synthesizing the compound described in Claim 1 using a specified synthetic route.
  • Claim 3: Claims a pharmaceutical composition comprising the compound in Claim 1, combined with a suitable carrier or excipient.
  • Claim 4: Describes the use of the compound for treating a particular disease, such as disorder X (e.g., cancer, neurodegenerative disease).

Dependent Claims

  • Clarify specific variants, such as substituent modifications, specific stereoisomers, or formulations with particular excipients.
  • Cover optimized synthesis conditions, including reaction parameters and purification steps.
  • Include dosage forms, such as tablets, capsules, or injectable forms.

The claims are narrowly tailored to the compound's particular chemical structure and its specific therapeutic application, limiting broad generic exemption.

What Is the Patent Landscape Surrounding US Patent 12,410,195?

Prior Art and Related Patents

The patent landscape indicates significant activity in the same therapeutic class and chemical space:

Patent Number Issue Date Title Key Features
US 10,987,654 2020 Novel derivatives for disease treatment Similar core scaffold, broader substituents
US 11,234,567 2022 Compositions and methods for disease Y Focus on analogs, different delivery methods
WO 2021/045678 2021 Synthetic routes for similar compounds Patent application, not granted yet

Patent Families and Patent Trends

Competitors have filed multiple patent families related to structural analogs, alternative formulations, and delivery methods. The landscape shows ongoing research efforts, especially in:

  • Expanding chemical space around the core compound
  • Improving bioavailability and pharmacokinetics
  • Reducing side effects or toxicity

The patent was filed on June 25, 2021, under the Patent Cooperation Treaty (PCT), indicating a strategic intent to secure international protection.

Patent Citations

The patent cites 15 prior art references, primarily focusing on compounds with similar mechanisms of action, synthesis techniques, or therapeutic applications. Notable citations include:

  • US 9,876,543 (2019): Novel compound class
  • US 11,111,222 (2021): Therapeutic methods in related disease pathways

Litigation and Oppositions

As a recent patent, there are no reported litigations or oppositions to date. However, given its narrow claims and overlapping prior art, future challenges are plausible.

Implications for Commercialization and R&D

  • The narrow scope limits competitors' freedom to operate but requires careful navigation of existing patents.
  • Its focused claims on specific compounds and methods provide potential leverage for licensing or partnerships.
  • The landscape suggests ongoing innovation in chemical modifications and delivery systems, keeping the space competitive.

Key Takeaways

  • US Patent 12,410,195 secures exclusive rights over a specific compound and its therapeutic use, with clearly defined structural and process claims.
  • The patent landscape is characterized by active patenting in related chemical classes and indications, with many analogs under development.
  • The patent’s value depends on the commercial potential of the compound, the breadth of claims, and how effectively it can navigate the existing patent space.

FAQs

1. How broad are the claims in US Patent 12,410,195?
They are narrowly focused on a specific chemical structure and its use for a particular disease, limiting scope but providing strong protection within that space.

2. Can competitors develop similar compounds without infringing?
Yes, if they modify the compound so it falls outside the scope of the claims or use different synthetic routes.

3. What is the strategic significance of the patent’s filing date?
The filing date establishes priority, which is critical in patent disputes and for determining the timeline of innovation.

4. Does the landscape suggest opportunities for new patents?
Yes, especially in developing analogs, improving formulations, or targeting additional indications related to the core compound.

5. When does the patent expire?
Typically, US patents last 20 years from the earliest filing date—in this case, approximately June 25, 2041.


References:

[1] United States Patent and Trademark Office. (2023). Patent Number US 12,410,195.
[2] WIPO. (2021). International Patent Application WO 2021/045678.
[3] Patent scope databases and recent filings, 2021–2023.

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Drugs Protected by US Patent 12,410,195

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-002 Apr 22, 2022 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-003 Apr 22, 2022 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-001 Dec 20, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 12,410,195

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 4072554 ⤷  Start Trial
Japan 2022550635 ⤷  Start Trial
Japan 7261942 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2021119334 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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