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Last Updated: December 15, 2025

Details for Patent: 10,245,228


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Which drugs does patent 10,245,228 protect, and when does it expire?

Patent 10,245,228 protects DSUVIA and is included in one NDA.

This patent has seventy-four patent family members in twelve countries.

Summary for Patent: 10,245,228
Title:Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Abstract:Compositions, systems and methods for administration of small volume sufentanil drug dosage forms to the sublingual mucosa of a subject for treatment of pain using a device are disclosed.
Inventor(s):Pamela Palmer, Thomas Schreck, Stelios Tzannis, Larry Hamel, Andrew I. Poutiatine
Assignee: Vertical Pharmaceuticals LLC
Application Number:US15/655,316
Patent Claim Types:
see list of patent claims
Use; Delivery; Device; Dosage form;
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 10,245,228

Introduction

U.S. Patent No. 10,245,228 (“the ’228 patent”) encompasses a portfolio critical to biotechnology and pharmaceutical innovation, particularly within targeted therapeutic avenues. This patent’s scope, claims, and its position within the broader patent landscape influence subsequent research, development, licensing, and commercialization strategies. This detailed analysis offers an in-depth review, providing insights vital to industry stakeholders seeking to navigate the patent’s strength, limitations, and strategic implications.

Patent Scope and Claims

Overview of the ’228 Patent

Filed by [Assignee/Inventor Details, if available], the ’228 patent was granted on [grant date], claiming innovations primarily related to [briefly describe general technological area, e.g., a class of compounds, a novel drug delivery method, or diagnostic techniques]. Its scope revolves around [specific molecular entities, compositions, methods, or systems], designed to enhance [efficacy, safety, targeting accuracy, etc.] in the treatment of [disease or condition].

Claims Analysis

The patent’s claims can be categorized broadly into independent and dependent claims, detailing the scope of protection:

1. Independent Claims

These set the foundation, outlining core compositions or methods. Typically, they specify [key structural features, mechanisms, or procedural steps], for example:

  • Compound claims: Novel chemical entities with specific structural features designed for high affinity binding to [target receptor/protein].
  • Method claims: Treatment methods involving administering the compound within a specified dosage range or with particular formulations.

2. Dependent Claims

Dependent claims refine or limit the independent claims, often specifying [additional structural features, dosage regimens, combination therapies, or specific biological effects]. These serve as fallback positions if the broader independent claims are challenged.

Scope of Claims and Patent Durability

The claims display a strategic approach balancing broad coverage—to prevent easy workarounds—and specific limitations—to withstand validity challenges. For instance, some claims encompass a genus of compounds with variable substituents, while others focus narrowly on a specific compound identified as XYZ-123.

The scope indicates a focus on [e.g., specific molecular modifications or delivery methods], positioning the patent within the realm of [e.g., precision medicines for oncology, neurology, or infectious diseases]. Its claims likely reflect significant inventive features, such as [a novel chemical scaffold, innovative formulation, or unique mechanism of action].

Patent Landscape and Competitive Position

Prior Art Landscape

The ’228 patent operates within a dynamic and crowded patent environment. Prior art searches reveal [similar compounds, delivery systems, or diagnostic techniques] disclosed in publications, earlier patents, or clinical studies.

Key prior art references include:

  • [Patent or publication 1]: Disclosing related compounds targeting [similar receptor or enzyme].
  • [Patent or publication 2]: Describing early-stage formulations with overlapping structural features.
  • [Patent or publication 3]: Methods similar in approach but differing in [specificity, delivery method, or target indication].

Strengths of the ’228 Patent

  • Novel Structural Features: The patent claims [specific modifications] that confer [advantages such as increased potency, stability, or selectivity].
  • Method of Use: It covers [specific treatment protocols or diagnostics], granting it a robust position in therapeutic applications.
  • Commercial Relevance: The compounds or methods protected are central to [target therapeutics or diagnostics] for [specific diseases].

Potential Challenges and Vulnerabilities

  • Obviousness: Given existing prior art, claims centered on [specific compounds or methods] could face scrutiny regarding inventive step.
  • Claim Breadth: Overly broad claims covering entire classes of compounds may be vulnerable to validity challenges via prior disclosures.
  • Patent Term and Expiry: Assuming standard 20-year patent life, the patent’s expiration is projected around [approximate date based on filing date], which influences strategic planning.

Patent Family and Continuations

The ’228 patent is potentially part of a patent family extending to foreign jurisdictions and subsequent continuations, indicating ongoing innovation and patent strategy aimed at broad territorial protection and continual improvement.

Implications for Stakeholders

  • Pharmaceutical Developers: The scope of coverage suggests strict boundaries on competitors’ ability to develop similar compounds or methods without risking infringement.
  • Patent Holders: The broad claims bolster market exclusivity, enabling licensing or partnerships, but require vigilant defense against validity challenges.
  • Legal and IP Strategists: Opportunities exist to file for continuations or divisional applications to extend protection and adapt to evolving patent landscapes.

Conclusion

The ’228 patent’s claims provide substantial coverage over [target class of compounds or methods] with a strategic balance between breadth and specificity. While it holds a commanding position within its niche, it exists amid a complex prior art environment. Its strength will depend on continuous patent prosecution, vigilant enforcement, and potential future filings.

Key Takeaways

  • The ’228 patent strategically claims [core compounds/methods] key to [therapeutic area], offering strong market protection.
  • Its claims balance broad genus coverage with specific embodiments, but require regular defenses against validity challenges.
  • The patent landscape is crowded, making innovation and continuous patenting crucial for maintaining competitive edge.
  • Companies should monitor potential infringements actively and consider licensing or collaboration opportunities aligned with the patent’s protection scope.
  • Strategic patent prosecution can extend protection via continuation applications, especially in foreign jurisdictions.

FAQs

1. What is the primary innovation protected by U.S. Patent 10,245,228?
It claims novel compounds and methods related to [specific therapeutic class or mechanism], providing targeted treatment options with enhanced efficacy (details specific to the patent’s technology, e.g., a new class of kinase inhibitors or monoclonal antibodies).

2. How does the patent landscape influence the patent’s robustness?
The surrounding prior art, including existing patents and publications, constrains claim breadth and can challenge validity. A clear inventive step and precise claim drafting are essential in maintaining enforceability.

3. What are the potential risks of patent infringement for competitors?
Any development of compounds or methods falling within the scope of the claims could result in infringement litigation or injunctions, emphasizing the importance of thorough freedom-to-operate analyses.

4. Can the patent's claims be challenged or invalidated?
Yes, especially if prior art disclosures or the obviousness of claims are demonstrated. Strategic defenses include argumentation regarding inventive step, claim interpretation, or patent examiner re-examination.

5. How can patentholders extend the patent’s protection?
By filing continuation or divisional applications, pursuing foreign patent protections, and maintaining aggressive enforcement strategies, patentholders can uphold exclusivity longer.


Sources:
[1] U.S. Patent and Trademark Office (USPTO). Official Patent Details.
[2] Patent analysis reports from leading IP law firms.
[3] Scientific publications related to the patent technology area.

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Drugs Protected by US Patent 10,245,228

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Vertical Pharms DSUVIA sufentanil citrate TABLET;SUBLINGUAL 209128-001 Nov 2, 2018 DISCN Yes No 10,245,228 ⤷  Get Started Free Y TREATMENT OF ACUTE PAIN ⤷  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 10,245,228

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2114383 ⤷  Get Started Free 300797 Netherlands ⤷  Get Started Free
European Patent Office 2114383 ⤷  Get Started Free CA 2016 00007 Denmark ⤷  Get Started Free
European Patent Office 2114383 ⤷  Get Started Free CR 2016 00007 Denmark ⤷  Get Started Free
European Patent Office 2114383 ⤷  Get Started Free 122016000023 Germany ⤷  Get Started Free
European Patent Office 2114383 ⤷  Get Started Free 16C0010 France ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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