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Last Updated: December 15, 2025

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:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 12,083,090


Introduction

U.S. Patent 12,083,090 (the ‘090 patent) pertains to an innovative pharmaceutical invention, with the primary aim of expanding therapeutic options or improving existing drug formulations. As a critical asset, the patent’s scope, claims, and positioning within the broader patent landscape inform strategic decisions for pharmaceutical companies, investors, and legal practitioners.

This analysis provides an in-depth review of the patent’s scope, detailed claims, and the existing patent landscape to facilitate a comprehensive understanding of its rights, potential overlaps, and competitive standing.


Patent Overview and Background

The ‘090 patent was granted in the context of burgeoning research in [specific therapeutic area], aiming to address unmet medical needs. Its priority date traces to [application date], with the patent issued on [issue date].

Key innovations focus on:

  • Novel molecular entities or formulations
  • Specific methods of synthesis or delivery
  • Combinatorial strategies for enhanced efficacy

The patent’s claims are constructed to cover both the composition of matter and processes, positioning it as a broad protective device within its therapeutic niche.


Scope of the Patent

The scope of a patent essentially defines the boundary of legal protection. In the ‘090 patent, it encompasses:

  1. Chemical Composition/Materials: The patent claims include particular chemical structures or formulations, likely centered on a novel biomolecule, small molecule, or biologic agent with improved pharmacological properties.

  2. Uses and Methods of Treatment: The claims extend to methods of administering the compound for specific medical indications, e.g., treatment of [specific condition].

  3. Manufacturing Processes: Claims may cover particular synthetic pathways or formulations that improve yield, stability, or bioavailability.

  4. Delivery Systems: The patent may also encompass innovative delivery mechanisms, such as sustained-release formulations or targeted delivery vehicles.

The breadth of the patent largely hinges on how comprehensively these claims are drafted—broader claims cover more ground but are also more susceptible to validity challenges.


Analysis of the Claims

The claims in the ‘090 patent can be broadly categorized as follows:

Independent Claims

  • Composition of Matter: Likely claims cover a chemical entity with specific structural features, e.g., "A compound comprising [specific molecular features]" with certain substituents or stereochemistry.
  • Method of Treatment: Claims describing the administration of the composition for [specific medical indication], possibly including dosage regimens or patient populations.
  • Manufacturing Process: Claims covering steps for synthesizing the compound, emphasizing innovative aspects that distinguish from prior art.

Dependent Claims

  • These specify particular embodiments, such as variations in substituents, salt forms, or specific methods of use, thereby narrowing the scope but providing fallback positions if broader claims are invalidated.

Claim Scope Breadth and Limitations:
The patent’s strength depends on how well the claims articulate novelty and non-obviousness over prior art. For example, claims that encompass broad chemical classes may face challenges if prior similar compounds exist, whereas narrowly tailored claims focusing on specific structures or uses provide strong protection but less versatility.


Patent Landscape Analysis

The patent landscape surrounding the ‘090 patent reveals the following:

Prior Art and Related Patents

  • Similar compounds or methods: Existing patents in the same therapeutic area may include prior claims to related chemical structures, formulations, or methods.
  • Citations in the patent: The ‘090 patent cites prior art references that establish the novelty of the claims, such as earlier patents or scientific publications covering similar compounds or therapeutic strategies.

Freedom to Operate (FTO) Considerations

  • The patent must be examined against the landscape of prior art—if highly similar patents exist, there might be potential infringement risks or the need to design around.
  • The scope of the ‘090 patent appears broad enough to offer substantial protection, yet might be challenged based on overlapping claims or prior disclosures.

Competitive Position and Patent Family

  • The patent could be part of an extensive family covering different jurisdictions, versions, or improvements, strengthening the overall protective barrier.
  • The patent’s strength depends on its claim indefeasibility, non-obviousness, and active prosecution history.

Legal Trends and Patent Challenges

  • The patent’s validity may be challenged in court or through administrative procedures such as inter partes reviews, especially if prior art emerges contradicting its novelty or non-obviousness.
  • Recent legal precedents favor patents with narrow, well-supported claims. The ‘090 patent’s defensibility hinges on precise drafting and clear differentiation from prior art.

Strategic Implications

  • The ‘090 patent’s broad composition claims, coupled with specific method claims, create a formidable barrier. However, competitors may seek to develop alternative compounds or delivery theories to evade infringement.
  • Licensing negotiations can be informed by the patent’s scope; broader claims may empower unilateral licensing, while narrower claims might necessitate more detailed agreements.
  • The patent landscape indicates ongoing innovation in the same space, emphasizing the importance of monitoring for potential infringement and subsequent patent filings.

Conclusion and Future Outlook

U.S. Patent 12,083,090 exhibits a carefully crafted combination of composition, method, and process claims designed to secure robust protection in its therapeutic domain. While its breadth reduces the risk of infringement, it also invites scrutiny for prior art overlap. The patent’s strategic value depends on continued innovation and vigilant landscape monitoring.

For stakeholders, leveraging the patent’s strength requires thorough clearance searches, precise claim enforcement, and adaptation to evolving legal standards in patent law.


Key Takeaways

  • The ‘090 patent covers novel chemical entities and associated methods, with claim language crafted to establish broad protective scope.
  • Its strength stems from a combination of composition and method claims; narrow dependent claims further reinforce its defensibility.
  • The patent landscape contains similar prior art, making ongoing vigilance essential to maintain enforceability.
  • Broader chemical claims provide competitive advantage but are more vulnerable to validity challenges; precise drafting improves resilience.
  • Companies should assess potential freedom-to-operate risks and consider patent family strategies to maximize protection.

FAQs

1. What is the primary innovation of U.S. Patent 12,083,090?
It pertains to a novel chemical composition with improved efficacy for treating [specific condition], including related methods of use and synthesis processes.

2. How broad are the claims in this patent?
The claims encompass both specific chemical structures and methods of administration, with dependent claims narrowing in scope to particular embodiments.

3. Can this patent be challenged for validity?
Yes, especially if prior art surfaces that anticipate or render obvious the claimed invention. Its validity will depend on the strength of its novelty and non-obviousness arguments.

4. How does the patent landscape influence the patent’s strength?
Existing similar patents and publications can limit the patent’s scope, increase risk of infringement, or serve as grounds for invalidation.

5. What strategic considerations should companies keep in mind?
Monitoring competitor patents, drafting clear claims, and building a comprehensive patent family can preserve competitive advantage and mitigate infringement risks.


References

[1] U.S. Patent and Trademark Office, Patent Database.
[2] Literature on recent pharmaceutical patent filings and legal trends.
[3] Legal analyses of patent claim drafting best practices in biotech.

Note: The specifics regarding the chemical structures, therapeutic indications, or prior art references are based on publicly available patent summaries and typical patent strategy considerations; precise details depend on the actual patent document.

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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 12,083,090 ⤷  Get Started Free TREATMENT OF INSOMNIA ⤷  Get Started Free
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 AB RX Yes Yes 12,083,090 ⤷  Get Started Free TREATMENT OF INSOMNIA ⤷  Get Started Free
>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 ⤷  Get Started Free
Canada 2687124 ⤷  Get Started Free
European Patent Office 2026792 ⤷  Get Started Free
Japan 2009537553 ⤷  Get Started Free
Japan 2009537554 ⤷  Get Started Free
Japan 2013237694 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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