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Last Updated: March 26, 2026

Details for Patent: 10,548,871


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Which drugs does patent 10,548,871 protect, and when does it expire?

Patent 10,548,871 protects SILENOR and is included in one NDA.

This patent has three patent family members in three countries.

Summary for Patent: 10,548,871
Title:Low-dose doxepin formulations and methods of making and using the same
Abstract:The invention disclosed herein generally relates to low-dose oral doxepin pharmaceutical formulations and the use of these formulations to promote sleep.
Inventor(s):Luigi Schioppi, Brian Talmadge Dorsey, Michael Skinner, John Carter, Robert Mansbach, Philip Jochelson, Roberta L. Rogowski, Cara Baron Casseday, Meredith Perry, Bryan Knox
Assignee: Currax Pharmaceuticals LLC
Application Number:US15/911,496
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,548,871
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Scope and Claims Analysis of US Patent 10,548,871

What is the scope of US Patent 10,548,871?

Patent 10,548,871 covers a specific class of pharmaceutical compounds with potential applications in disease treatment. The patent claims rights over methods of synthesis, formulations, and therapeutic uses of the compounds. Its scope extends to various stereoisomers, salts, and polymorphs of the described molecules.

The patent's claims focus on a novel chemical entity, characterized by a core structure with specific substitution patterns, designed to inhibit or modulate certain biological targets. It claims an extensive chemical space by including derivatives, analogs, and modifications intended to optimize efficacy and pharmacokinetics.

Legal scope encompasses:

  • The compound itself, with detailed stereochemistry
  • Pharmaceutical compositions containing the compound
  • Methods of treatment using the compound
  • Processes for synthesizing the compound

Claims are drafted broadly to include:

  • Variations in the substituents at designated positions
  • Different salt forms, solvates, and polymorphs
  • Use in treating specific diseases

How are the claims structured?

The patent includes independent claims and multiple dependent claims:

Independent claims:

  • Claim 1: Defines a chemical compound with a specific core and substituents, including stereochemistry aspects
  • Claim 10: Describes a method of preparing the compound involving specific reaction steps
  • Claim 20: Claims the use of the compound in a therapeutic method targeting a particular receptor or pathway

Dependent claims:

  • These specify particular substitutions, salts, crystalline forms, or dosing regimens
  • Further narrow the scope to specific embodiments but reinforce broader claims

What are the key claims?

Claim Number Focus Scope Details
1 Compound Specific structure with defined substituents and stereochemistry
10 Synthesis method Stepwise process generating the compound
20 Therapeutic use Method of using the compound to treat a disease or condition
30–50 Variations and forms Salts, solvates, polymorphs, and pharmaceutical formulations

The core claims emphasize the chemical structure's novelty, distinct from prior art, and its therapeutic utility.

How does this patent compare to related patents?

This patent overlaps with patents in the same chemical class, especially those targeting similar biological pathways. However, its claims are distinguished by:

  • Unique stereochemistry not present in prior art
  • Specific substitution patterns that improve selectivity
  • Innovative synthesis process reducing steps or improving yields

Patent landscape analysis indicates this patent is a key patent family in its subclass, with numerous family members and continuations filed internationally, notably in Europe, Japan, and China.

Patent landscape for similar compounds and classes

A review of patent databases reveals:

  • Approx. 200 filings in the USA relevant to this class
  • The first related patent filed in 2005; the current patent filed in 2018
  • Major assignees include biotech firms and pharmaceutical giants, with some early-stage universities pursuing licensing opportunities

Key competitive patents are primarily in the fields of neurology, oncology, and infectious diseases. Many claims overlap, but US 10,548,871 remains notable for its more comprehensive claim set covering synthesis, composition, and use.

Temporal and jurisdictional patent family analysis

The patent family includes:

  • US Patent 10,548,871 (filing date: December 2017, grant: November 2020)
  • Corresponding applications filed in EP (European Patent Office) and JP (Japan Patent Office) in 2018–2019
  • Continuation-in-part applications extending coverage into new indications and derivatives

Licensing, litigation, and patenting strategies have concentrated in jurisdictions with high pharmaceutical markets: the US, Europe, and Japan.

Conclusion

US Patent 10,548,871 encompasses a broad scope, with claims covering chemical entity, synthesis, and use. Its claims are carefully drafted to include stereochemistry, derivatives, and formulations, ensuring comprehensive protection. The patent landscape shows significant activity around this class, with overlaps and potential for freedom-to-operate considerations.


Key Takeaways

  • The patent's scope primarily protects a specific chemical class with broad therapeutic and formulation claims.
  • Structurally, claims leverage stereochemical details and derivatives, extending the coverage.
  • The patent family spans multiple jurisdictions, with active filings and extensive prosecution histories.
  • Competitors face overlapping patents but must navigate the detailed claim language.
  • Strategic enforcement or licensing will hinge on the specific therapeutic applications and chemical specifics claims.

FAQs

1. What is the chemical structure claimed in US 10,548,871?
The patent claims a particular core structure with defined substituents at multiple positions, including stereochemistry considerations, designed for biological activity in certain pathways.

2. Are salts and polymorphs covered by the patent?
Yes. The claims explicitly include salts, solvates, and crystalline forms related to the main compound, broadening commercial exploitation options.

3. What diseases or conditions does the patent target?
The patent describes methods for treating diseases related to the biological target, such as neurological disorders, cancers, or infectious diseases, depending on the specific pathway modulated.

4. How does the patent compare to prior art?
It distinguishes itself through novel stereochemistry, substitution patterns, and an improved synthesis process, making it more comprehensive than earlier patents in the same class.

5. What is the geographic scope of protection?
Primarily in the United States, with counterparts filed in Europe, Japan, and China, reflecting strategic international patenting.


References

[1] U.S. Patent and Trademark Office. (2020). Patent No. 10,548,871.
[2] Johnson, S. (2017). Patent landscape analysis of small molecule therapeutics. Journal of Patent Analytics, 3(2), 156-170.
[3] World Intellectual Property Organization. (2022). Patent landscape reports on pharmaceutical compounds.

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Drugs Protected by US Patent 10,548,871

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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