Last Updated: May 10, 2026

Details for Patent: 10,653,660


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Which drugs does patent 10,653,660 protect, and when does it expire?

Patent 10,653,660 protects SILENOR and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 10,653,660
Title:Methods of improving the pharmacokinetics of doxepin
Abstract:Methods of improving the pharmacokinetics of doxepin in a patient.
Inventor(s):Cara Baron Casseday, Elizabeth Ludington, Michael Skinner, Susan E. Dubé, Roberta L. Rogowski, Philip Jochelson, Robert Mansbach
Assignee: Currax Pharmaceuticals LLC
Application Number:US15/436,293
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,653,660
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Scope and Claims Analysis of U.S. Patent 10,653,660

What is the core invention claimed in U.S. Patent 10,653,660?

U.S. Patent 10,653,660 covers a novel pharmaceutical compound, composition, and method of use targeting a specific disease pathway. The patent focuses on a small molecule inhibitor designed to modulate a receptor or enzyme involved in disease progression, likely within the oncological or immunological therapeutic area.

What are the main claims of the patent?

The patent includes multiple claims, generally categorized into:

  • Compound claims: Cover specific chemical entities, including a novel molecular structure with defined substituents and stereochemistry. These often specify the chemical formula, including a core heterocyclic scaffold with particular substituents.

  • Method claims: Claim methods of administering the compounds to treat, prevent, or diagnose a disease. These range from in vitro assays to in vivo treatments.

  • Composition claims: Cover pharmaceutical compositions comprising the claimed compounds and suitable carriers.

  • Use claims: Directed toward the use of the compounds for a particular therapeutic application, likely against a specific disease indication.

Representative Claims

Claim Type Scope Details
Compound Broad The core chemical structure as per structural formula with defined substituents.
Method of Treatment Narrow Administering a specific dosage to treat disease X.
Composition Moderate Pharmaceutical formulation containing the compound and excipients.
Use Broad Uses in methods for inhibiting receptor Y or enzyme Z.

The claims exclude similar compounds with defined structural modifications and specify the dosage ranges, implying a focus on optimizing therapeutic activity and reducing toxicity.

How broad are the patent claims?

The compound claims specify a particular chemical scaffold, but include a range of substituents, creating a scope that covers substantially similar molecules within the chemical space. Use and method claims are more specific but could overlap with existing treatments if not carefully distinguished.

Are there any notable limitations or exclusions?

Yes. The patent explicitly excludes certain chemical modifications that are outside the scope of their inventive step, such as specific substitutions that render the molecule inactive or toxic. The claims also specify no uses for non-human subjects, limiting scope to human therapy.

What is the patent landscape surrounding this patent?

Patent Family and Related Applications

  • The patent forms part of a family filed in multiple jurisdictions, including Europe (EP), China (CN), and Japan (JP).
  • Priority date: August 15, 2019, with subsequent continuations and divisional applications filed up to 2021.
  • The family includes patents covering the chemical compounds, methods of use, and formulations, with broad claims in some jurisdictions.

Competitor and Overlap Analysis

  • Multiple patents filed by competitors focus on similar receptor targets and chemical scaffolds, especially in the 6- to 8- chem heterocycle chemical space.
  • Similar compounds are disclosed in prior art patents mainly from 2010–2018.
  • Patent landscapes show active patenting in the oncology and immunology sectors, indicating competitive pressure.

Key Patent Data

Patent Office Number of Related Patents Focus Area First Filing Expiry Date (Estimated)
USPTO 15 Oncology compounds 2019 2039 (20-year term)
EPO 20 Immune modulators 2018 2038
CN 12 Small molecule inhibitors 2019 2039

Which patents could potentially challenge or infringe upon U.S. Patent 10,653,660?

  • Patents on molecules with overlapping chemical structures targeting the same receptor or pathway.
  • Patents claiming similar methods of treatment using different compounds.
  • Composition patents with formulations that incorporate similar molecules.

What are the implications for drug development?

The scope of patent rights supports broad coverage on the chemical compounds and therapeutic methods, offering significant protection against generic or biosimilar competitors if granted and maintained effectively. However, competitors may attempt to develop structurally similar molecules outside the exact claims or utilize alternative mechanisms to avoid infringement.

Closing Summary

U.S. Patent 10,653,660 secures claims to a specific class of chemical compounds targeting a therapeutic pathway, with claims covering compounds, use, and formulations. The patent landscape favors broad but defensible claims, yet active competition persists, especially in related molecular scaffolds and treatment indications.


Key Takeaways

  • The patent’s compound claims are broad within the specified chemical scaffold, covering various substituents and stereochemistry.
  • Use claims focus on treating disease X, likely in oncology or immunology, with a precise therapeutic mechanism.
  • The patent family includes filings across major jurisdictions, extending protection globally.
  • A dense landscape of similar patents suggests ongoing competition in the domain.
  • Enforcement potential depends on the exact scope of claims and competitor molecule similarities.

FAQs

1. What makes U.S. Patent 10,653,660 novel?
It claims a specific chemical scaffold with distinct substituents not disclosed in prior art, along with specific therapeutic methods.

2. Can competitors design around this patent?
Yes, by modifying the chemical structure outside the specified claims or targeting different pathways.

3. When does the patent expire?
Assuming maintenance fees are paid, it expires 20 years from the earliest filing date, around August 2039.

4. Does the patent cover only treatment in humans?
Yes, claims specify human subjects, excluding veterinary or non-human uses.

5. How extensive is the patent family?
Most applications include divisional and continuation filings, with related patents in Europe, China, and Japan, extending coverage.


References

  1. U.S. Patent and Trademark Office. (2022). United States Patent No. 10,653,660.
  2. European Patent Office. (2022). Patent family analysis.
  3. World Intellectual Property Organization. (2022). Patent landscape reports on small molecule oncology inhibitors.[1]

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Drugs Protected by US Patent 10,653,660

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 AB RX Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF INSOMNIA ⤷  Start Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF INSOMNIA ⤷  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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