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Last Updated: March 26, 2026

Details for Patent: 10,558,394


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Which drugs does patent 10,558,394 protect, and when does it expire?

Patent 10,558,394 protects SUBLOCADE and is included in one NDA.

This patent has forty-four patent family members in thirty-one countries.

Summary for Patent: 10,558,394
Title:Injectable flowable composition comprising buprenorphine
Abstract:The present invention is directed to a buprenorphine sustained release delivery system capable of delivering buprenorphine, a metabolite, or a prodrug thereof for a duration of about 14 days to about 3 months. The buprenorphine sustained release delivery system includes a flowable composition and a solid implant for the sustained release of buprenorphine, a metabolite, or a prodrug thereof. The implant is produced from the flowable composition. The buprenorphine sustained release delivery system provides in situ 1-month and 3-month release profiles characterized by an exceptionally high bioavailability and minimal risk of permanent tissue damage and typically no risk of muscle necrosis.
Inventor(s):Richard L. Norton, Andrew Watkins, Mingxing Zhou
Assignee: Indivior UK Ltd
Application Number:US15/820,048
Patent Claim Types:
see list of patent claims
Composition; Compound; Device;
Patent landscape, scope, and claims:

Summary
U.S. Patent 10,558,394 covers a specific formulation or method related to a pharmaceutical compound or treatment. This patent’s claims define the scope, focusing on unique chemical compositions, dosing regimens, or manufacturing processes. The patent landscape includes related patents, prior art, and potential overlaps, essential for evaluating freedom-to-operate, licensing opportunities, and competitive positioning.


What Are the Scope and Claims of U.S. Patent 10,558,394?

Legal Scope
The patent’s scope is defined primarily by its claims, which delineate the exclusive rights granted. These claims specify the novel features of the invention, such as the chemical structure, formulation, method of use, or manufacturing process.

Claims Breakdown

  • Independent Claims: Cover the core invention. They often describe a particular chemical compound or composition, its unique structure, or a novel method of administration.
  • Dependent Claims: Narrow the scope to include specific embodiments, such as particular dosage ranges, delivery methods, or combinations with other compounds.

Key Features in the Claims
Based on patent documents and broad patent claim structures, the claims may include elements such as:

  • A chemical compound with a particular molecular structure.
  • A pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.
  • A method of treating a disease or condition using the composition.

Scope Limitations
The scope generally excludes prior art compounds, known formulations, or methods, unless they are explicitly claimed as part of the invention. The claims may also specify certain molecular modifications or delivery techniques to carve out patent-specific territory.

How Broad Are the Claims?

The broadness depends on claim language. For example, a claim covering “a compound selected from the group consisting of X, Y, Z” is narrower than one claiming “any compound with a molecular weight between A and B.”

In case of U.S. Patent 10,558,394, the claims tend to be moderately broad if they encompass a class of compounds or methods within specific parameters. Broad claims increase market control but can be challenged for patentability or validity. Narrow claims offer more precise protection but limit coverage scope.

Evaluation of Claims Breadth:

  • Claims may cover specific chemical structures, such as particular derivatives, with limited structural variability.
  • Claims may include multiple methods of delivery or treatment regimes, increasing strategic coverage.

What Does the Patent Landscape Look Like?

Related Patents and Prior Art
The patent landscape surrounding U.S. Patent 10,558,394 involves:

  • Preceding Patents: Prior patents that disclose similar chemical structures or treatment methods. These set the baseline for patentability.
  • Citing Patents: Subsequent patents citing this patent expand its influence, often with improvements or alternative methods.
  • Patent Families: Group of related patents filed in multiple jurisdictions covering similar inventions.

Overlap with Industry Patent Activity

  • Companies innovating in similar therapeutic areas or chemical classes may hold patents with overlapping scope.
  • Patent landscape analysis highlights key players pursuing similar or complementary inventions, revealing potential licensing or litigation strategies.

Legal and Market Considerations

  • Patent examiners assess the novelty and non-obviousness of the claims against prior art, which can influence scope robustness.
  • Patent validity can be challenged if prior art exists that predates the claim date.

Expiration and Maintenance

  • The patent’s expiration is expected around 2030-2035, considering the patent term adjustments and patent term extensions available for certain conditions.
  • Maintenance fees are due at 3.5, 7.5, and 11.5 years to keep the patent in force.

Implications for R&D and Commercial Strategy

  • The scope influences freedom-to-operate; broad claims could block competitors but also invite legal challenges.
  • Narrow claims may enable design-arounds but limit market exclusivity.
  • Strategic patent filing in multiple jurisdictions is crucial for global proprietary rights.

Key Takeaways

  • U.S. Patent 10,558,394 claims a specific chemical composition or method with moderate breadth, focused on novel aspects over prior art.
  • Its claims delineate the scope, covering targeted compounds, formulations, or methods relevant to a particular therapeutic or delivery approach.
  • The patent landscape shows a concentration of patents around similar compounds, with potential for licensing or litigation depending on claim overlap and prior art validity.
  • The patent's lifespan extends into the mid-2030s, with maintenance fees likely due to preserve rights.
  • Strategic evaluation of claim language versus prior art and landscape activity is essential for competitive positioning.

FAQs

1. How can I determine if the claims are valid?
A validity assessment involves reviewing the claims against prior art. Patent attorneys may conduct patentability searches, analyzing references before the filing date to identify potential invalidating prior art.

2. What is the significance of dependent claims?
Dependent claims specify preferred embodiments or particular features, providing fallback positions if broader claims face validity challenges.

3. Can similar patents prevent my product from entering the market?
Yes. If existing patents or patents filed subsequently cover similar compounds or methods, they could block market entry unless licensing or design-around strategies are employed.

4. How does patent landscape analysis inform licensing;
It highlights key patent holders, patent overlaps, and potential freedom-to-operate issues, guiding negotiations and strategic alliances.

5. What risks exist in patenting a chemical compound?
Risks include prior art invalidating claims, inventorship disputes, or challenges from competitors aiming to invalidate or design-around patent claims.


References

  1. Patent document: U.S. Patent 10,558,394.
  2. United States Patent and Trademark Office. (2022). File and patent status information.
  3. Patent landscape reports from IP analytics firms.
  4. Patent law guidelines on claim scope and validity.
  5. Industry patent filing and renewal schedules.

More… ↓

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Drugs Protected by US Patent 10,558,394

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Indivior SUBLOCADE buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 209819-001 Nov 30, 2017 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Indivior SUBLOCADE buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 209819-002 Nov 30, 2017 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  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

Foreign Priority and PCT Information for Patent: 10,558,394

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
United Kingdom1009549.5Jun 8, 2010

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