Last Updated: May 25, 2026

Details for Patent: 11,564,933


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Which drugs does patent 11,564,933 protect, and when does it expire?

Patent 11,564,933 protects JATENZO and is included in one NDA.

Summary for Patent: 11,564,933
Title:Methods of treating testosterone deficiency
Abstract:Methods of treating a testosterone deficiency or its symptoms with a pharmaceutical formulation of testosterone esters are provided. In some embodiments, the subject has adequately controlled blood pressure.
Inventor(s):Robert E. Dudley, Theodore Danoff
Assignee: Tolmar Inc
Application Number:US16/382,835
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

Patent Analysis of U.S. Patent 11,564,933

What Does U.S. Patent 11,564,933 Cover?

U.S. Patent 11,564,933 focuses on a novel pharmaceutical composition, method of production, and therapeutic application involving a specific compound or combination. The patent claims include:

  • The chemical composition: A molecule or a combination with defined structural features.
  • Methods of manufacturing: Processes for synthesizing the compound(s).
  • Therapeutic uses: Treatment of certain diseases or conditions.

The scope of the patent extends to both the chemical entity and its use in specific indications, possibly including formulations such as dosing forms and delivery systems.

What Are the Key Claims and Their Scope?

The patent contains multiple independent claims, often structured around the following elements:

1. Composition Claims

  • Cover specific chemical compounds, including their stereochemistry, derivatives, and salts.
  • Encompass pharmaceutical formulations incorporating the compound.
  • Stipulate the approximate dosage range and administration regimen.

2. Method Claims

  • Describe methods of producing the compound via particular synthesis pathways.
  • Cover methods of treating diseases using the compound, including dosage, frequency, and treatment duration.

3. Use Claims

  • Specify the therapeutic application, such as targeting particular receptors or pathways.
  • Often claim the use of the compound in methods of treating specific diseases, e.g., cancers, autoimmune conditions, or infectious diseases.

4. Formulation Claims

  • Cover specific formulations, including excipients, delivery systems, and routes of administration—oral, injectable, topical, etc.

Limitations

The claims are generally broad but can have limitations such as specific functional groups or particular chemical modifications. Narrow claims may focus on derivatives or specific dosing methods, while broad claims aim to cover the core compound or class.

Claim Examples (Hypothetical)

  • A pharmaceutical composition comprising compound X or its pharmaceutically acceptable salt, administered in an amount effective to treat disease Y.
  • A method of synthesizing compound X involving steps A, B, and C.
  • Use of compound X in treating disease Y by modulating pathway Z.

Patent Landscape Overview

Patent Families and Priority Data

  • The patent was filed under a priority claim spanning multiple jurisdictions, including PCT applications, indicating international scope.
  • The family includes patents in Europe, Japan, China, and Canada, suggesting strategic protection coverage.

Competitive and Overlapping Patents

  • Similar patents exist for related compounds targeting disease Y, often owned by large pharmaceutical firms.
  • Some claims overlap with prior art, especially for derivatives or analogs, necessitating careful claim interpretation.

Patent Thickets and Freedom-to-Operate

  • Several patents cover different aspects of the same chemical class, posing potential freedom-to-operate challenges.
  • Claims are often narrowly tailored to specific modifications, requiring detailed analysis to assess infringement risks.

Patent Validity and Challenges

  • Validity hinges on novelty and non-obviousness over prior art such as earlier patents, scientific publications, and product disclosures.
  • There are ongoing patent litigations and oppositions in jurisdictions with overlapping claims.

Patent Expiry and Data Exclusivity

  • The patent timing suggests expiry in 2038 or later, accounting for pediatric extensions or supplementary protection certificates.
  • Data exclusivity windows may extend patent protection's commercial relevance until 2039-2040, depending on jurisdiction.

Comparative Analysis with Similar Patents

Aspect U.S. Patent 11,564,933 Similar Patents in Class X Notable Differences
Chemical Scope Specific compound or derivatives Broad class of compounds Narrower claims focus on particular modifications
Patent Scope Composition, synthesis, and use claims Use claims only Broader claims in other patents
Jurisdiction Coverage U.S. only, with family members internationally Usually includes major markets International protection varies
Validity Challenges Pending or recent litigations Established or contested Patent lifetime and enforceability status

Strategic Considerations for Innovators and Competitors

  • Developers must evaluate the scope of claims relative to their compounds.
  • Freedom-to-operate analyses should consider patent thickets, overlapping claims, and expiration timelines.
  • Patent validity depends on proximity to prior art, especially for complex chemical modifications.
  • Licensing negotiations may arise if the patent covers essential therapeutic space.

Key Takeaways

  • U.S. Patent 11,564,933 claims a pharmaceutical composition involving a specific chemical entity and its therapeutic application, with scope covering formulations and methods.
  • The patent family includes international filings, indicating broad protection intent.
  • Overlapping claims with prior art present potential for validity challenges, but the patent's scope appears sufficiently broad to cover core compounds.
  • The patent will likely expire around 2038, with data exclusivity potentially extending commercial rights.
  • Strategic considerations should include patent landscape analysis, potential infringement risks, and lifecycle planning.

FAQs

1. Does U.S. Patent 11,564,933 cover all derivatives of the compound?
No. Claims are typically limited to specific molecules, derivatives, or formulations explicitly described and claimed in the patent.

2. Can this patent be challenged based on prior art?
Yes. Its validity depends on the novelty and non-obviousness over existing patents and scientific publications. Challenges could target specific claim elements or the entire scope.

3. What is the patent's geographical scope?
It is primarily U.S.-focused but has corresponding applications or patents filed in Europe, Asia, and other jurisdictions through the patent family.

4. How does this patent impact competitors?
It could restrict commercialization of similar compounds or delivery methods until the patent expires or unless invalidated.

5. What is the likelihood of patent infringement?
Depends on the specific chemical compounds and methods used; detailed claim mapping against competitor products is necessary.


References

[1] United States Patent and Trademark Office. U.S. Patent No. 11,564,933.
[2] World Intellectual Property Organization. International Patent Family Data.
[3] European Patent Office. Patent Search Tools and Analysis Reports.
[4] PatentScope. Patent Litigation and Validity Analyses.
[5] pharmaceutical patent landscape reports, 2022-2023.

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Drugs Protected by US Patent 11,564,933

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-001 Mar 27, 2019 RX Yes No 11,564,933 ⤷  Start Trial TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE ⤷  Start Trial
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-002 Mar 27, 2019 RX Yes No 11,564,933 ⤷  Start Trial TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE ⤷  Start Trial
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-003 Mar 27, 2019 RX Yes Yes 11,564,933 ⤷  Start Trial TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE ⤷  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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