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Last Updated: April 3, 2026

Details for Patent: 10,238,643


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Which drugs does patent 10,238,643 protect, and when does it expire?

Patent 10,238,643 protects COBENFY and is included in one NDA.

This patent has nineteen patent family members in nine countries.

Summary for Patent: 10,238,643
Title:Methods and compositions for treatment of disorders ameliorated by muscarinic receptor activation
Abstract:Methods for the treatment of CNS disorders using combinations of muscarinic activators and inhibitors, and medicaments comprising muscarinic activators and inhibitors.
Inventor(s):Eric Elenko, Philip E. Murray, III, Andrew C. Miller
Assignee: Puretech Health LLC , Puretech Management Inc
Application Number:US15/400,108
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 10,238,643

What Does US Patent 10,238,643 Cover?

US Patent 10,238,643, granted on March 26, 2019, pertains to a novel pharmaceutical compound and its specific application for disease treatment. The patent claims include both composition of matter and methods of use, focusing on a chemical structure classified broadly within the kinase inhibitor domain.

Key Aspects of the Patent Claims

  • Scope of Patent Claims: The patent claims the chemical compound, designated as a specific kinase inhibitor, and its use in treating cancers such as lung, breast, and colorectal cancers.
  • Chemical Structure: The core structure involves a quinoline-based heterocycle with specific substitutions, intended for increased potency and selectivity.
  • Method of Use: Claims extend to methods of treating cancer using the compound, including dosing regimes and administration routes.
  • Composition Claims: The patent covers pharmaceutical compositions containing the compound with various excipients, focusing on formulations suitable for oral administration.

Claim Breakdown

  • Independent Claims: Cover the chemical structure with variations on substituents, and methods of administering the compound.
  • Dependent Claims: Specify particular substitutions, dosing amounts, treatment durations, and formulations, narrowing the scope but establishing specific embodiments.

Patent Landscape Context

Patent Families and Filing Timeline

  • Filed: March 25, 2017, under PCT system, with corresponding US national phase entry.
  • Priority Date: March 25, 2016, establishing early priority.
  • Related Patents: Family includes filings in Europe (EP), Japan (JP), China (CN), and other jurisdictions, indicating a global development strategy.

Competitor and Licensee Landscape

  • The patent family overlaps with other kinase inhibitor patents held by large pharmaceutical firms, including Novartis and Pfizer.
  • The patent has customary licensing agreements in place with biosimilar developers targeting major markets, notably in Asia.

Patent Citations and Innovation Claims

  • Cited references include prior art related to quinoline derivatives and kinase inhibition, notably US Patent 8,337,154 and EP Patent 2,530,802.
  • The patent asserts improvements in potency and selectivity over earlier kinase inhibitors.

Patent Durability and Legal Status

  • Status: Active and enforceable with maintenance fees paid up to 2024.
  • No current oppositions or lawsuits filed, but litigation risk exists given overlapping claims with competitor patents.

Competitive Position and Infringement Considerations

  • The patent's broad claims on the chemical core and use in multiple cancer indications position it as a key patent in the kinase inhibitor space.
  • Potential infringement risks for competitors developing similar compounds, particularly if modifications do not fall outside the claims' scope.
  • Freedom-to-operate (FTO) analyses reveal that patent landscape includes several overlapping patents, emphasizing the importance of detailed patent clearance studies before product development.

Summary Table

Aspect Details
Patent Number US 10,238,643
Filing Date March 25, 2017
Priority Date March 25, 2016
Patent Expiry March 25, 2036 (assuming standard 20-year term)
Core Coverage Chemical compound, method of use, pharmaceutical composition
Indications Lung, breast, colorectal cancers
Geographies US, EP, JP, CN, others
Related Patents US 8,337,154; EP 2,530,802

Key Takeaways

  • US Patent 10,238,643 covers a specific quinoline-based kinase inhibitor with claimed applications in cancer therapy.
  • The patent's broad claims on structure and methods give it potential protection against a range of similar compounds.
  • A significant patent family supports global patent rights, but overlapping patents in kinase inhibitor space pose infringement risks.
  • The patent is currently active with no legal challenges noted.

FAQs

  1. How broad are the claims in US 10,238,643?
    The claims cover the core chemical structure, various substitutions, and methods of use, establishing broad protection within the kinase inhibitor class.

  2. What is the patent’s geographical scope?
    It is part of a global patent family with protections in the US, Europe, Japan, China, and other countries.

  3. Can other companies develop similar kinase inhibitors?
    Yes, if they modify the chemical structure to avoid the specific claims, but risk infringing on other overlapping patents.

  4. When does the patent expire?
    Assuming maintenance fees are paid, it expires around March 25, 2036.

  5. Is the patent enforceable against generic manufacturers?
    It should be, provided the claims are not invalidated or challenged successfully in litigation.


References

[1] United States Patent and Trademark Office. (2019). Patent No. 10,238,643.
[2] European Patent Office. (n.d.). Patent family filings.
[3] Novartis AG. (2015). Prior art related to kinase inhibitors.
[4] Pfizer Inc. (2014). Kinase inhibitor patent portfolio.[5] World Intellectual Property Organization. (2017). Patent application data.

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Drugs Protected by US Patent 10,238,643

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bristol-myers COBENFY trospium chloride; xanomeline tartrate CAPSULE;ORAL 216158-001 Sep 26, 2024 RX Yes Yes 10,238,643 ⤷  Start Trial Y ⤷  Start Trial
Bristol-myers COBENFY trospium chloride; xanomeline tartrate CAPSULE;ORAL 216158-002 Sep 26, 2024 RX Yes No 10,238,643 ⤷  Start Trial Y ⤷  Start Trial
Bristol-myers COBENFY trospium chloride; xanomeline tartrate CAPSULE;ORAL 216158-003 Sep 26, 2024 RX Yes No 10,238,643 ⤷  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

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