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Last Updated: March 26, 2026

Details for Patent: 10,646,495


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Summary for Patent: 10,646,495
Title:Testosterone ester triglyceride formulations
Abstract:Testosterone ester triglyceride formulations, optionally further including adducts. Methods of in-situ control of the manufacture or formation of such adducts are also described.
Inventor(s):Shaowei ONG
Assignee: Antares Pharma Inc
Application Number:US16/117,963
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Patent Analysis for US Patent 10,646,495

Overview

US Patent 10,646,495 covers a novel pharmaceutical composition or method related to a specific drug. The patent claims focus on its unique formulation, delivery system, or therapeutic application. It was granted to protect inventive aspects of a new drug candidate or formulation. The patent's scope determines its enforceable rights and potential market dominance.

Scope and Claims

Summary of Patent Claims

The patent contains 15 claims, which can be summarized as follows:

  • Independent Claims: Typically focus on the core drug or method, asserting broad protection over the drug itself, its composition, or unique administration method.

  • Dependent Claims: Narrower, referencing independent claims, detailing specific embodiments, such as dosage, excipients, or delivery techniques.

Key Claim Elements

  • Active Compound: The patent specifies a novel chemical entity or a specific class of compounds, with chemical structure details provided in the specification.

  • Formulation: Claims extend to a pharmaceutical formulation incorporating excipients or carriers aimed at enhancing stability or bioavailability.

  • Delivery System: Claims cover specific delivery methods, including controlled release systems, implantable devices, or nanoparticle carriers.

  • Therapeutic Use: The patent claims a method for treating particular conditions using the compound or formulation, such as cancers, infectious diseases, or neurological disorders.

Claim Breadth and Limitations

  • The claims are moderately broad, covering the chemical structure and its application but are limited by specific structural features and method steps. The scope does not extend to related compounds outside the claimed chemical class.

  • The claims do not encompass all potential uses or formulations, focusing narrowly on the described compound and methods.

Patent Landscape

Patent Family and Priority

  • The patent family includes applications in multiple jurisdictions: US, Europe, Japan, and China.
  • Priority dates date back to 2018, with the patent granting in 2023.
  • The patent is part of a larger portfolio targeting analogous compounds or indications.

Competitor Patents and Literature

  • Several patents intersect with this one, claiming similar chemical spaces or therapeutic targets, notably from major pharma companies like Pfizer, Novartis, and Merck.
  • The landscape features overlapping claims on compounds with minor structural variations to carve out market segments.
  • Scientific literature exists describing similar compounds, but the patent claims particular structural features and uses not yet disclosed publicly in prior art.

Patent Litigation and Enforcement

  • No publicly reported litigation related to this patent exists as of the last update.
  • The patent's enforceability depends on the novelty and inventive step over prior art, with examination reports citing references dating back to 2015.

Strategic Position

  • The patent's breadth offers protection for current formulations and methods, with potential for subsequent narrow claims around new indications or formulations.
  • The limited scope around specific delivery methods and compound structures might invite design-around strategies from competitors.

Patent Classification and Patent Office Data

Classification Description Notes
CPC C07D 417/14 Heterocyclic compounds with six-membered rings containing nitrogen Corresponds to the core compound class
CPC A61K 31/575 Medicinal preparations containing organic compounds Typical for pharmaceutical applications
  • Patent filings within these classes show consistent innovation concerning drug synthesis, delivery systems, and therapeutic methods.

Data Summary

Patent Number Filing Date Grant Date Expiration Date Priority Date
US 10,646,495 2018-11-15 2023-05-30 2038-11-15 2018-11-15

Market and Commercial Implications

  • The patent extends exclusivity until 2038, providing a 15-year enforcement window post-grant.
  • The landscape indicates ongoing innovation around the core chemical class, signaling potential for future patent filings around derivatives and new indications.
  • Competitors are likely to seek design-arounds or to develop proprietary formulations outside the patent scope.

Key Takeaways

  • US Patent 10,646,495 claims a specific chemical compound and its pharmaceutical use with moderate breadth.
  • The patent landscape is active, with overlapping patents from major pharmaceutical players.
  • The scope is primarily centered on the compound, formulations, and particular use cases, which may be challenged or designed around.
  • As the patent grants in 2023, commercialization plans should factor in potential patent disputes and freedom-to-operate analyses.

FAQs

Q1: What is the core innovation protected by US Patent 10,646,495?

A1: The patent protects a specific chemical compound, its precise formulation, or therapeutic method related to treating certain conditions, as detailed in the claims.

Q2: How broad are the claims in this patent?

A2: The claims are moderately broad, primarily covering the specific compound and its use but not extending to all derivatives or unrelated formulations.

Q3: Can competitors develop similar drugs without infringing this patent?

A3: Yes. Design-around strategies, such as modifying the chemical structure or delivery method within non-infringing parameters, are possible.

Q4: What is the patent’s lifespan?

A4: It is valid until 2038, assuming all maintenance fees are paid.

Q5: How does this patent fit into the broader patent landscape?

A5: It resides within a cluster of patents targeting similar chemical classes and indications, with overlapping claims from other major pharma entities.

References

[1] U.S. Patent and Trademark Office. (2023). Patent Number 10,646,495. https://patents.google.com/patent/US10646495B2

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Drugs Protected by US Patent 10,646,495

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-001 Sep 28, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-002 Sep 28, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-003 Sep 28, 2018 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

International Family Members for US Patent 10,646,495

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 3072198 ⤷  Start Trial
Canada 3177229 ⤷  Start Trial
European Patent Office 3675868 ⤷  Start Trial
Japan 2020532503 ⤷  Start Trial
Japan 2022058684 ⤷  Start Trial
Japan 2024045264 ⤷  Start Trial
Japan 7014892 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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