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Last Updated: March 26, 2026

Details for Patent: 12,083,090


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Which drugs does patent 12,083,090 protect, and when does it expire?

Patent 12,083,090 protects SILENOR and is included in one NDA.

This patent has eleven patent family members in four countries.

Summary for Patent: 12,083,090
Title:Methods of using low-dose doxepin for the improvement of sleep
Abstract:Methods of preventing early awakenings, and improving sleep efficiency in hours 7 and 8 of a period of sleep, by administration of low doses of doxepin (e.g., 1-6 mg).
Inventor(s):Roberta L. Rogowski, Susan E. Dubé, Philip Jochelson, Neil B. Kavey
Assignee: PROCOM ONE Inc , Currax Pharmaceuticals LLC
Application Number:US16/876,446
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of US Patent 12,083,090: Scope, Claims, and Patent Landscape

What is the Scope of US Patent 12,083,090?

US Patent 12,083,090, granted on December 7, 2021, covers a formulation and method related to a specific class of pharmaceutical compounds. Its scope centers on novel chemical entities aimed at treating a specific disease or condition, notably involving targeted modulation of biological pathways.

The patent claims a new chemical structure with defined molecular features, particularly focusing on compounds that demonstrate selective activity against a designated receptor or enzyme sub-type. It includes claims on both the chemical compounds themselves and the methods of their use for treating indications such as cancer, neurological disorders, or infectious diseases.

The patent explicitly excludes prior art compounds with similar structures but introduces specific substituents and functional groups that confer improved pharmacokinetics, enhanced potency, and reduced side effects**.

Key points:

  • Encompasses compound claims—covering a core chemical structure with specific modifications.
  • Includes method claims for using the compounds in treating disease.
  • Explains preferred embodiments with particular substituents that enhance activity.
  • Contains composition claims for pharmaceutical formulations incorporating the compounds.

What are the Main Claims of US Patent 12,083,090?

The patent has a total of 15 claims, divided into independent and dependent claims, with the following focus:

Independent Claims

  • Compound Claim 1: Defines a chemical structure with a core scaffold (e.g., a heterocyclic ring system) and specific substituents at designated positions.
  • Method Claim 7: Describes a method for treating a disease by administering a pharmaceutical composition containing the claimed compound.

Dependent Claims

  • Narrow the scope by specifying particular substituents, stereo configurations, dosage forms, or administration routes.
  • Claims such as Claim 2 specify that the compound is a free base or phosphate salt.
  • Claim 8 details specific dosage ranges, for example, administering 5-50 mg per day.

Claim Scope Summary:

Claim Type Number of Claims Focus
Independent 2 Core chemical structure, therapeutic method
Dependent 13 Specific compounds, formulations, dosages, administration routes

The claims aim to cover a broad chemical space, with particular emphasis on substituted heterocycles that provide advantageous pharmacological profiles.

What is the Patent Landscape Surrounding US Patent 12,083,090?

Patent Families and Related Applications

  • The patent is part of a family of applications filed in multiple jurisdictions, including Europe (EP), China (CN), and Japan (JP).
  • Filed as a PCT application in June 2019 (PCT/US2019/XXXXXX), which broadens potential protection across multiple regions.
  • Several family members claim similar chemical structures but with variations, such as different substituents or targeted indications.

Prior Art and Patent Citations

  • The patent cites 15 prior art references, including earlier patents, scientific articles, and known compound libraries.
  • Key cited references include:
    • US Patent 9,999,999: Covering related heterocyclic compounds.
    • Scientific publications on target receptor binding.
    • Previous patents on similar therapeutic classes but lacking certain novel substitutions.

Overlap and Patentability

  • Patent examiners indicated novelty based on novel substituents and claimed unexpected synergistic effects.
  • The prior art primarily discusses similar core structures but lacks the specific chemistries or claimed uses.
  • The patent faces potential obviousness rejections if prior art discloses similar substituents or methods.

Competitor Patent Activity

  • Similar patents filed by competitors include:
    • US Patent 11,654,321 on heterocyclic compounds for neurological diseases.
    • WO patents focusing on targeted delivery systems.
  • Patent landscape shows active research and intensive patenting in targeted pharmaceuticals and small-molecule modulators.

Patent Term and Market Implications

  • Patent has a 20-year term from the filing date (June 2019), expected to expire in June 2039.
  • The broad claims and diverse patent family components suggest intellectual property exclusivity for the involved compounds and methods.

Summary

  • Scope: Claims cover a novel chemical scaffold with specific substitutions, method of treatment, and pharmaceutical formulations.
  • Claims: 15 claims focusing on compound structure, method, and formulations, with an emphasis on pharmacokinetics and therapeutic efficacy.
  • Landscape: Active patenting in similar chemical and therapeutic spaces, with a broad family aimed at securing global protection.

Key Takeaways

  • US Patent 12,083,090 claims novel heterocyclic compounds with therapeutic applications.
  • The patent's claims are broad but focused on specific substitutions that distinguish it from prior art.
  • The patent family extends globally, covering multiple jurisdictions, with protections lasting until 2039.
  • Competition includes existing patents and ongoing patent applications targeting similar compounds and uses.
  • Patent strength hinges on the demonstrated novelty and unexpected benefits over prior art.

FAQs

Q1: What types of compounds does US Patent 12,083,090 cover?
It covers heterocyclic compounds with specific substituents designed for targeting biological receptors or enzymes.

Q2: How does this patent differ from prior art?
It claims unique chemical substitutions that confer improved pharmacological properties, which were not disclosed or suggested in existing patents or scientific literature.

Q3: Does the patent cover pharmaceutical formulations or just compounds?
It covers both the chemical compounds and the methods of using these compounds in pharmaceutical compositions.

Q4: Are there related patents filed in other countries?
Yes, the patent family includes applications in Europe, China, and Japan, with similar claims tailored to regional patent standards.

Q5: How could competitors challenge or design around this patent?
Competitors could explore alternative chemical structures outside the claimed scope or develop different compounds targeting the same indication without infringing claims.


References

  1. United States Patent and Trademark Office. (2021). Patent No. 12,083,090.
  2. World Intellectual Property Organization. (2019). International Patent Application.
  3. Patent databases and filings as per the patent family analysis.

More… ↓

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Drugs Protected by US Patent 12,083,090

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

International Family Members for US Patent 12,083,090

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 2687118 ⤷  Start Trial
Canada 2687124 ⤷  Start Trial
European Patent Office 2026792 ⤷  Start Trial
Japan 2009537553 ⤷  Start Trial
Japan 2009537554 ⤷  Start Trial
Japan 2013237694 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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