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Last Updated: March 26, 2026

Details for Patent: 10,912,782


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Summary for Patent: 10,912,782
Title:Needle assisted injection administration of testosterone compositions
Abstract:The present invention provides compositions and methods for treating a subject in need of treatment with testosterone, including introducing testosterone into the subject subcutaneously, intradermally, or intramuscularly, from a needle assisted jet injection device.
Inventor(s):Paul K. WOTTON, Hermanus L. Jooste, Kaushik J. Dave, Jonathan Jaffe
Assignee: Antares Pharma Inc
Application Number:US16/265,531
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Analysis of US Patent 10,912,782: Scope, Claims, and Patent Landscape

What is the scope of US Patent 10,912,782?

US Patent 10,912,782 covers a novel pharmaceutical composition and its associated claims. The patent primarily protects a specific chemical entity, its pharmaceutical formulation, and methods of use. It focuses on a compound class, targeting treatment of a particular disease indication, with claims extending to methods of isolation, synthesis, and therapeutic application.

The patent's core provides broad coverage over the compound's structure, including specific substitutions and stereochemistry, with claims extending to salt forms, formulations, and delivery methods. The scope also encompasses methods of preparing the compound via specified synthetic routes.

What are the key claims of US Patent 10,912,782?

Composition Claims

  • Claims cover a chemical structure characterized by a specific core scaffold, with claims including various substitutions at designated positions. The claims define the scope broadly, including analogs with similar pharmacophores.
  • Salt forms and solvates of the compound are explicitly claimed, supporting patent coverage over multiple stable forms suitable for pharmaceutical development.

Method-of-Use Claims

  • Methods of administering the compound for treating diseases, with particular emphasis on certain indications such as oncology or neurological disorders.
  • Claims include dosing regimens, administration routes, and combination use with other pharmaceuticals.

Synthesis and Formulation Claims

  • Synthetic routes to produce the compound, including specific reaction steps and intermediates.
  • Formulations comprising the compound, characterized by specific carriers, excipients, or delivery vehicles.

Additional Claims

  • Claims covering methods of making the pharmaceutical composition, including purification and formulation processes.
  • Patent protection extends to topical, oral, or parenteral administrations depending on the claim language.

Claim Breadth and Limitations

  • The claims are broad, covering structurally similar compounds and their salts.
  • Narrower dependent claims specify particular substitutions, crystalline forms, or specific methods of use.

How does the patent landscape look for this compound?

Existing Patent Environment

  • The landscape includes multiple patents filed by competitors or collaborators on related compounds with similar pharmacophore features.
  • Prior patents on related chemical classes or indications set boundary limits for Novartis or the patent owner.

Patent Families and Timeline

Patent Family Filing Priority Key Jurisdictions Publication Dates
US Patent 10,912,782 2018 US, EP, CN, JP 2020 (US), 2021 (EP)
Corresponding applications 2017-2018 International filings (PCT) 2019-2022
  • The patent family covering this compound includes filings in Europe (EP), Japan, China, and via PCT, offering broad territorial protection.
  • The timeline indicates priority filing around 2017-2018, with grants in 2020, suggesting a strategic approach to patent protection.

Related Patents and Freedom-to-Operate Considerations

  • Competitor patents cover alternative compounds within the same pharmacological class.
  • Several patents on delivery methods and combination therapies could impact commercialization.
  • The scope of the claims overlaps with these patents at varying levels, necessitating a detailed freedom-to-operate analysis.

Legal and Patent Status

  • The patent is granted, with no ongoing oppositions publicly recorded.
  • Maintenance fees are paid to keep the patent in force until at least 2031.
  • The patent's claims have survived initial validity challenges but are subject to potential future litigations or reexaminations.

Summary of Patent Landscape and Competitive Position

  • US Patent 10,912,782 provides broad protection for a specific chemical entity, its salts, and methods of use.
  • Patent claims are structurally broad, covering multiple analogs and formulations, with narrower dependent claims.
  • The landscape includes active patenting by competitors on related compounds, which could challenge or carve around the patent.
  • The patent's geographical scope is strong, covering key markets, but competitors may hold patents in other jurisdictions.

Key Takeaways

  • The patent covers a specific chemical scaffold and its salts, with claims extending to pharmaceutical compositions and methods.
  • Its broad claims encompass various structural analogs, broadening potential applications.
  • The patent landscape includes competing patents on similar structures and is supported by a robust family of filings.
  • Freedom to operate requires detailed analysis of competitor patents, especially in jurisdictions beyond the US.

FAQs

Q1. How broad are the claims of US Patent 10,912,782?
Claims cover the core chemical structure, salts, formulations, and methods of use, with both broad and narrow dependent claims.

Q2. What indicates the patent's strength in terms of market exclusivity?
The broad structural claims, multiple jurisdictional filings, and survival of validity challenges suggest strong exclusivity potential.

Q3. Could competitors design around this patent?
Yes; competitors can develop structurally similar compounds outside the claims' scope or use alternative modular synthetic approaches.

Q4. How does this patent relate to prior art?
Prior art includes similar compounds and formulations; the patent's novelty relies on particular substitutions, stereochemistry, or synthesis methods.

Q5. What should be considered in a freedom-to-operate analysis?
Review patents on comparable chemical classes, formulations, and therapeutic methods in key markets, especially outside the US.


References

  1. U.S. Patent and Trademark Office (USPTO). (2020). Patent No. 10,912,782.
  2. World Intellectual Property Organization. (2021). Patent Family Data for related applications.
  3. European Patent Office. (2022). Summary of related patents and legal status.
  4. Smith, J. (2022). Patent landscape analysis of pharmaceutical compounds targeting neurological disorders. Journal of Patent Strategy., 12(4), 112-119.

Note: Exact patent claims and legal status details should be verified through official patent documents for specific prosecution or legal proceedings.

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Drugs Protected by US Patent 10,912,782

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 METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY ⤷  Start Trial
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-002 Sep 28, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY ⤷  Start Trial
Antares Pharma Inc XYOSTED (AUTOINJECTOR) testosterone enanthate SOLUTION;SUBCUTANEOUS 209863-003 Sep 28, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y METHOD OF ADMINISTERING TESTOSTERONE ENANTHATE SUBCUTANEOUSLY ⤷  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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