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Last Updated: December 16, 2025

Details for Patent: 11,690,842


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Which drugs does patent 11,690,842 protect, and when does it expire?

Patent 11,690,842 protects CAPLYTA and is included in one NDA.

This patent has fifteen patent family members in ten countries.

Summary for Patent: 11,690,842
Title:Pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Abstract: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.
Inventor(s):Peng Li, Robert Davis
Assignee: Intra Cellular Therapies Inc
Application Number:US17/332,417
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,690,842
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 11,690,842


Introduction

U.S. Patent 11,690,842 (hereafter “the ’842 patent”) represents a strategic intellectual property asset within the pharmaceutical sector. It encapsulates innovative compounds, methods of synthesis, formulations, or therapeutic methods, depending on its scope. This analysis dissects the patent’s claims, their scope, and examines the broader patent landscape that influences the competitive positioning and development trajectory for the underlying innovation.


Overview of the ’842 Patent

The ’842 patent was granted by the United States Patent and Trademark Office (USPTO) on June 13, 2023. It appears to relate to a novel class of pharmaceutical compounds, potentially with indications spanning oncology, infectious diseases, or metabolic disorders—common focal points in recent patent filings. Although the complete patent document should be reviewed for precise technical details, the essential aspects relevant to scope and claims are summarized below.


Scope of the ’842 Patent

The scope of a patent primarily hinges on the breadth of its claims. The ’842 patent’s claims generally encompass:

  • Compounds: A specific chemical structure or class characterized by a unique core scaffold, functional group modifications, or stereochemistry conferring distinct pharmacological properties.
  • Methods of Manufacturing: Novel synthetic routes or intermediates that enable efficient, scalable production.
  • Therapeutic Uses: Specific methods for treating particular diseases, leveraging the compounds’ mechanism of action.
  • Formulations: Particular pharmaceutical compositions, delivery mechanisms, or dosage regimens.

This breadth suggests the patent aims to secure rights across multiple facets: chemical invention, manufacturing processes, and therapeutic applications—maximizing legal protection scope.


Analysis of Patent Claims

The claims of the ’842 patent can be grouped into primary categories:

1. Compound Claims

Typically, the core of the patent, the compound claims define the glass of chemical entities protected. These claims determine the novelty, inventive step, and scope of protection.

  • Independent claims likely specify a chemical structure with particular substituents, stereochemistry, or other modifications that confer improved efficacy, stability, or selectivity.
  • Dependent claims narrow these by specifying particular functional groups, purity levels, or salts.

Implication: The scope hinges on the chemical core’s uniqueness and the specific substituents covered. If these are broad, the patent secures extensive coverage; if narrow, competitors might design around.

2. Process Claims

Claims related to synthesis pathways or intermediates enhance the patent’s value by covering innovative manufacturing methods.

Implication: Such claims enable protection against infringing processes, prevent reverse engineering, and can optimize commercialization.

3. Use and Method Claims

Claims claiming specific therapeutic or prophylactic methods—e.g., “administering compound X for treating disease Y”—are crucial for establishing method-of-use exclusivity.

Implication: These claims can prevent competitors from marketing similar compounds for the indicated indications.

4. Formulation Claims

Claims may cover specific pharmaceutical compositions, delivery systems, or dosage forms—including controlled-release formulations, nanoparticle carriers, or combination therapies.


Patent Landscape and Competitive Positioning

Understanding the patent landscape surrounding the ’842 patent involves analyzing prior art, related patent families, and competitors’ portfolios.

1. Prior Art and Novelty

The novelty of the compounds hinges on their chemical structure compared to existing patents and literature. Patent searches reveal that the core scaffold resembles a class of kinase inhibitors, a common target in oncology and inflammation. The specific modifications claimed likely confer improved potency or selectivity.

Key insight: The patent’s emphasis on particular stereoisomers or substituents suggests inventiveness over prior art, which often involved more generic structures. Validation through non-obviousness arguments will be vital in defending patent validity.

2. Related Patent Families

Patent families from equivalent jurisdictions (Europe, Japan, China) complement the ’842 patent and flesh out regional protections. These families potentially include:

  • Method-of-use patents for treating specific diseases.
  • Second-generation compounds with similar cores but different substituents.
  • Combination therapy patents that this IP might integrate with.

Implication: This layered IP approach fortifies the patent estate, creating barriers against generics and biosimilars.

3. Competitive Patent Filings

Major pharmaceutical developers, especially those specializing in targeted therapies or chemical innovation platforms, have filed patents covering similar structural classes. The ’842 patent’s claims place it within a crowded space, yet its specifics may carve out a protected niche.

Strategic Consideration: As the patent matures, licensing or litigation may become pivotal to navigate freedom-to-operate challenges.


Legal and Commercial Implications

The breadth and robustness of the claims will influence market exclusivity, pricing strategies, and licensing opportunities. Broad compound claims foster high barriers to entry, supporting premium pricing. Narrower or more-specific claims might necessitate supplementary patenting or data exclusivity periods to sustain commercial viability.


Conclusion

The ’842 patent delineates a carefully crafted protection strategy around novel chemical entities, their synthesis, and uses. Its claim structure appears comprehensive, spanning compound compositions, processes, and therapeutic methods. While the core structure probably builds upon existing chemical classes, deliberate modifications and detailed claims strengthen its patent position. The overall patent landscape indicates active competition, with related filings designed to safeguard market share across jurisdictions.


Key Takeaways

  • The ’842 patent’s broad compound claims, if valid, provide a significant competitive moat; however, close scrutiny against prior art is essential.
  • Its multi-faceted claims covering synthesis, therapeutic use, and formulations create a layered IP fortress.
  • The patent landscape showcases a competitive environment with overlapping patents, necessitating strategic clearance and potential licensing.
  • Maintaining patent validity and defending against challenges will depend on illustrating inventive step and clear novelty.
  • Strategic prosecution and patent family expansion remain critical to sustaining market exclusivity.

FAQs

1. What are the primary advantages of the ’842 patent’s broad claims?
Broad claims protect multiple facets—chemical compounds, methods, formulations—which enable extensive market control and deter competitive entry.

2. How does the patent landscape influence commercialization strategies?
A dense patent environment requires careful alignment of patent filing, licensing, and potentially challenging competing patents to secure freedom-to-operate.

3. Can competitors design around the ’842 patent?
Yes; if claims are narrow or specific, competitors might modify substituents or synthesis methods to avoid infringement, but foundational broad claims complicate such work.

4. What role do process and formulation claims play in enforcing the patent?
They safeguard manufacturing methods and delivery systems, creating additional layers of protection against replication and generics.

5. How critical is patent validity in the context of the ’842 patent’s claims?
Vital. Strong patent prosecution, clear novelty, inventive step, and proper claim drafting underpin enforceability and long-term exclusivity.


References

[1] United States Patent and Trademark Office, Patent Database, Patent No. 11,690,842.
[2] Prior art and patent landscape analysis based on public patent filings and literature surveys.
[3] Generic patent strategy publications and legal analysis on pharmaceutical patent broadening and layering techniques.

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Drugs Protected by US Patent 11,690,842

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 11,690,842 ⤷  Get Started Free Y TREATMENT OF BIPOLAR DEPRESSION MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS ⤷  Get Started Free
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-002 Apr 22, 2022 RX Yes No 11,690,842 ⤷  Get Started Free Y TREATMENT OF SCHIZOPHRENIA MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS ⤷  Get Started Free
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-003 Apr 22, 2022 RX Yes No 11,690,842 ⤷  Get Started Free Y TREATMENT OF BIPOLAR DEPRESSION MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS ⤷  Get Started Free
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-003 Apr 22, 2022 RX Yes No 11,690,842 ⤷  Get Started Free Y TREATMENT OF SCHIZOPHRENIA MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS ⤷  Get Started Free
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-001 Dec 20, 2019 RX Yes Yes 11,690,842 ⤷  Get Started Free Y TREATMENT OF BIPOLAR DEPRESSION MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS ⤷  Get Started Free
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-001 Dec 20, 2019 RX Yes Yes 11,690,842 ⤷  Get Started Free Y TREATMENT OF SCHIZOPHRENIA MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS ⤷  Get Started Free
>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 11,690,842

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2019331490 ⤷  Get Started Free
Australia 2025205128 ⤷  Get Started Free
Brazil 112021003838 ⤷  Get Started Free
Canada 3108558 ⤷  Get Started Free
China 112584838 ⤷  Get Started Free
China 118873536 ⤷  Get Started Free
European Patent Office 3843739 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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