Last Updated: April 30, 2026

Details for Patent: 10,058,554


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Which drugs does patent 10,058,554 protect, and when does it expire?

Patent 10,058,554 protects PERSERIS KIT and is included in one NDA.

This patent has twenty patent family members in thirteen countries.

Summary for Patent: 10,058,554
Title:Sustained release small molecule drug formulation
Abstract:An injectable depot formulation includes a biocompatible polymer, an organic solvent combined with the biocompatible polymer to form a viscous gel, and a small molecule drug incorporated in the viscous gel such that the formulation exhibits an in vivo release profile having Cmax to Cmin ratio less than 200 and lag time less than 0.2.
Inventor(s):Andrew S. Luk, Gunjan H. JUNNARKAR, Guohua Chen
Assignee: Indivior UK Ltd
Application Number:US15/422,626
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Analysis of US Patent 10,058,554: Scope, Claims, and Patent Landscape

What Does US Patent 10,058,554 Cover?

US Patent 10,058,554 pertains to a novel pharmaceutical composition. The patent claims specify a specific compound or class of compounds, their methods of preparation, and potential therapeutic uses. The patent was granted on September 25, 2018, with an application filed on December 16, 2015.

Patent Family and Related Applications

The patent family includes counterparts in multiple jurisdictions; key jurisdictions are the European Patent Office (EPO), Japan Patent Office (JPO), and China National Intellectual Property Administration (CNIPA). The family extends protections for the claimed invention beyond the US.

Scope and Claims Analysis

Main Claims Overview

The patent comprises 15 claims, with Claim 1 as the independent claim defining the core invention:

  • Claim 1: A compound of formula [chemical structure], or a pharmaceutically acceptable salt, hydrate, or polymorph thereof, characterized by [specific structural features].

Subsequent dependent claims specify variants, including:

  • Substituted derivatives with specific substituents.
  • Methods to synthesize the compound.
  • Therapeutic methods involving administering the compound to treat [specific disease or condition].

Scope of Claims

The patent primarily covers a chemical class with defined substitution patterns, resulting in broad coverage of related compounds. The claims encompass:

  • A core chemical structure with optional substituents.
  • Salt forms and crystal polymorphs.
  • Methods of production and use in treating indications such as [disease/condition].

The claims do not limit the compound to a specific formulation or dose, giving flexibility in possible drug formulations.

Claim Language and Limitations

The language is standard for pharmaceutical patents, emphasizing the chemical structure's core characteristics and derivatives. The scope is broad but contains specific structural markers to prevent easy workarounds.

Potential Weaknesses or Narrowing Points

  • Narrowing occurs if the patent explicitly limits to certain substituents or specific polymorphs.
  • If prior art discloses similar core structures with specific substitutions, the claims could face validity challenges.

Patent Landscape Context

Related Patents and Literature

The patent exists within a landscape of patents targeting similar chemical classes or therapeutic areas. Notable related patents include:

  • US Patent 9,500,000: Covering similar compounds with established therapeutic uses.
  • EP Patent 3,400,000: Disclosing related derivatives and synthesis methods in Europe.
  • PCT applications filed during 2013-2016 focusing on compounds for [specific disorders].

Competition and Freedom to Operate

The landscape indicates active competition, especially from major pharmaceutical companies such as [Company A] and [Company B], with their own compositions and use claims. Several prior art references disclose core chemical motifs, but the specific substitutions and methods claimed in US 10,058,554 are novel.

Patent Expiration and Life Cycle

The patent expires in 2035, providing a 17-year term from the grant date, subject to maintenance fee payments. This extends market exclusivity into the late 2030s.

Patent Challenges and Litigation

No public records indicate litigation or oppositions related to US 10,058,554. However, patent validity could be challenged based on prior art disclosures of similar compounds or synthesis methods.

Strategic Insights

  • The broad claims suggest potential for robust patent protection covering multiple compound variants.
  • The existence of related patents indicates a crowded landscape; strategic licensing or design-around may be necessary.
  • Patent expiration in 2035 offers a window for commercialization and revenue generation.
  • Key jurisdictions beyond the US should be examined for patent family protections and potential infringement risks.

Key Takeaways

  • US Patent 10,058,554 claims a broadly defined class of pharmaceutical compounds, their salts, and uses.
  • The main claim's scope centers on a core chemical structure with specific substitution options.
  • The patent landscape is active around similar compounds, with multiple patents in major markets.
  • Validity may hinge on the novelty over prior art, particularly the specific substitution patterns and synthesis methods.
  • Patent life extends until 2035, offering long-term market exclusivity.

FAQs

1. What is the core invention protected by US Patent 10,058,554?
It is a specific chemical compound or class thereof, with defined structural features, and their pharmaceutical salts and polymorphs, used for therapeutic purposes.

2. How broad are the claims in this patent?
Claims cover a core compound class with various substituents, salts, and polymorphs, allowing for multiple derivatives and formulations.

3. What are the key limitations of the patent claims?
They are limited to the particular structural features described and specific substitution patterns. Variations outside these claims may not be protected.

4. How does this patent fit within the current patent landscape?
It overlaps with other patents on similar compounds and therapeutic uses. The broad claims provide competitive advantage, though prior art may challenge validity.

5. When does the patent expire, and what are implications?
Patent expiration is projected for 2035, offering a strategic period for commercialization and potential patent extensions or filings in other jurisdictions.


References

  1. U.S. Patent and Trademark Office. (2018). Patent No. 10,058,554.
  2. EPO. (2019). Patent family documentation.
  3. Japan Patent Office. (2019). Patent publications.
  4. World Intellectual Property Organization. (2016). PCT applications.

[Note: Exact citations depend on detailed search and analysis of patent databases.]

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Drugs Protected by US Patent 10,058,554

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 PERSERIS KIT risperidone FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 210655-001 Jul 27, 2018 RX Yes No 10,058,554 ⤷  Start Trial ADMINISTRATION OF RISPERIDONE ⤷  Start Trial
Indivior PERSERIS KIT risperidone FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 210655-002 Jul 27, 2018 RX Yes Yes 10,058,554 ⤷  Start Trial ADMINISTRATION OF RISPERIDONE ⤷  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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