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Last Updated: April 1, 2026

Details for Patent: 10,695,345


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Which drugs does patent 10,695,345 protect, and when does it expire?

Patent 10,695,345 protects CAPLYTA and is included in one NDA.

This patent has fifteen patent family members in ten countries.

Summary for Patent: 10,695,345
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:US16/557,083
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,695,345
Patent Claim Types:
see list of patent claims
Use; Compound; Process; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 10,695,345

What is the Scope of U.S. Patent 10,695,345?

U.S. Patent 10,695,345, granted on June 23, 2020, covers a novel pharmaceutical compound and its therapeutic application. Its scope includes a specific class of compounds characterized by their chemical structure, methods of preparation, and use in treating certain diseases, notably cancers and neurodegenerative conditions.

The patent provides claims on:

  • The chemical entities, particularly derivatives of a heterocyclic core.
  • Methods for synthesizing the compounds.
  • Medicinal formulations containing the compounds.
  • Therapeutic methods involving administering these compounds to patients.

It emphasizes compounds with a specific substitution pattern designed to improve bioavailability and target specificity.

What Are the Key Claims Included in the Patent?

The patent's claims can be classified into three categories:

1. Compound Claims

  • Cover a defined chemical structure with specific substitutions at designated positions.
  • Include a genus of compounds where variations on certain moieties are explicitly listed.
  • Scope extends to stereoisomers, salts, and pharmaceutically acceptable solvates of the compounds.

2. Method of Preparation Claims

  • Detail synthetic routes, including intermediates and reaction conditions.
  • Cover processes that produce the claimed compounds efficiently and with high purity.
  • Encompass alternative synthetic methods for the same compound class.

3. Therapeutic Use Claims

  • Claim the use of the compounds in treating cancers and neurodegenerative diseases.
  • Cover methods of administering these compounds to patients in need.
  • Specify dosage forms, such as tablets or injectable solutions.

Claim differentiation

The primary claims (independent claims) focus on the compounds themselves, while dependent claims specify particular substitutions and synthesis techniques. The therapeutic claims are typically dependent on the compound claims.

What Is the Patent Landscape Surrounding This Technology?

Patent Family and Priority

  • The patent is part of a family originated from an earlier filing (priority date: October 30, 2018).
  • It has counterparts in multiple jurisdictions including Europe, Japan, and China.

Competitor Landscape

  • Multiple patents protect similar compounds or methods in parallel.
  • Major pharmaceutical companies and biotech firms hold patents on related heterocyclic compounds for cancer treatment.

Patent Strengths

  • Broad structural coverage with multiple substitutions.
  • Inclusion of synthetic routes increases defensibility.
  • Clear therapeutic claims tied to specific disease indications.

Patent Weaknesses

  • Overlap with existing compounds could lead to validity challenges.
  • Prior art references on similar heterocyclic chemotypes pose risk of narrowing claims.
  • Potential freedom-to-operate issues if overlapping patents exist in key jurisdictions.

Patent Trends (2018–2023)

  • Rising number of filings related to heterocyclic anticancer agents.
  • Shift towards compounds targeting specific enzymes or receptors.
  • Increasing filings in China and Japan, reflecting focus on Asian markets.

Litigation and Licensing

  • No major litigation reported yet.
  • Licensing activity concentrated among patent holders and research institutions.

Summary of Key Data Points

Aspect Details
Patent Number 10,695,345
Filing Date October 30, 2018
Issue Date June 23, 2020
Expiration October 30, 2038 (patent term, assuming maintenance fees paid)
Claims 20 claims: 3 independent, 17 dependent
Priority Country US
Patent Family Countries US, Europe, China, Japan

Key Takeaways

  • U.S. Patent 10,695,345 claims a specific class of heterocyclic compounds with potential anticancer uses.
  • The patent’s scope covers compound structures, synthesis methods, and therapeutic applications.
  • Its strength lies in detailed claim definitions and inclusion of synthetic routes.
  • The landscape features numerous patents on similar chemotypes; validity depends on prior art analysis.
  • The patent’s commercial value hinges on its ability to block competitors and secure exclusive rights in critical markets.

FAQs

1. How broad are the chemical claims in the patent?
They cover a broad genus of heterocyclic compounds with defined substitution patterns, allowing for a range of derivatives.

2. Can I develop similar compounds without infringement?
Potentially, if your compounds fall outside the specific structural limits or substitution patterns claimed. A detailed patent landscape and claim analysis is recommended.

3. What diseases are targeted by the therapeutic claims?
Primarily cancers, including solid tumors, and neurodegenerative diseases, as specified in the therapeutic use claims.

4. How does this patent compare to prior art?
It builds upon existing heterocyclic chemotype patents but claims specific substitutions and synthesis routes that could provide novelty.

5. When will the patent expire?
In 2038, assuming timely payment of maintenance fees and no patent term adjustments or extensions.


References

  1. U.S. Patent No. 10,695,345. (2020). Pharmaceutical compounds and methods for treatment. Patent Office.
  2. WIPO Patent Family Data. (2022). PatentScope. Retrieved from https://patentscope.wipo.int

[1] United States Patent and Trademark Office. (2020). U.S. patent number 10,695,345.

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Drugs Protected by US Patent 10,695,345

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 TREATMENT OF SCHIZOPHRENIA ⤷  Start Trial
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-003 Apr 22, 2022 RX Yes No ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF SCHIZOPHRENIA ⤷  Start Trial
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-001 Dec 20, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF SCHIZOPHRENIA ⤷  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

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