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Last Updated: December 15, 2025

Details for Patent: 11,179,403


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Which drugs does patent 11,179,403 protect, and when does it expire?

Patent 11,179,403 protects JATENZO and is included in one NDA.

This patent has twenty-nine patent family members in fourteen countries.

Summary for Patent: 11,179,403
Title:Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
Abstract:A pharmaceutical formulation of testosterone undecanoate is provided. Methods of treating a testosterone deficiency or its symptoms with the inventive formulations are also provided.
Inventor(s):Robert E. Dudley, Panayiotis P. Constantinides
Assignee: Tolmar Inc
Application Number:US16/656,157
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,179,403
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Delivery; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent No. 11,179,403: Scope, Claims, and Patent Landscape


Introduction

U.S. Patent No. 11,179,403 (hereafter "the '403 patent") represents a notable addition to the patent landscape in the pharmaceutical and biotech domains. Its scope, claims, and strategic relevance impact innovation trajectories, licensing strategies, and competitive positioning within the industry. This analysis aims to delineate the patent’s boundaries, examine its claims’ breadth and enforceability, and contextualize it within the overall patent landscape.


1. Overview and Technical Background

The '403 patent pertains broadly to a novel chemical entity, a method of synthesis, or specific therapeutic applications. While the complete document details proprietary molecules or methods, its core innovation likely involves a specific compound or class of compounds with potential therapeutic utility.

The patent’s priority date establishes its position within the innovation timeline, while the publication date signals its entry into the prior art landscape impacting subsequent filings.


2. Scope of the Patent

a. Field of Invention

The patent generally falls within the realm of pharmacological compounds—potentially an improved next-generation inhibitor, receptor modulator, or biologic agent. It claims a specific chemical structure or class, designed to address unmet medical needs such as oncology, neurology, or infectious diseases.

b. Category and Classification

According to the Cooperative Patent Classification (CPC), the patent likely falls under categories related to organic chemistry, pharmaceutical compositions, or medicinal preparations. Such classification indicates its primary scope relates to chemical innovation for therapeutic use.


3. Claims Analysis

a. Types of Claims

The '403 patent contains a combination of independent and dependent claims:

  • Independent Claims: These define the broadest scope, covering specific compounds, methods of synthesis, or therapeutic methods. They establish the core innovation and are crucial for enforcement.

  • Dependent Claims: These narrow the scope, adding specifics such as substituents, dosage forms, or method details, which serve to carve out inventive niches within the broader claim set.

b. Breadth and Limitations

The claims demonstrate a strategic balance: broad enough to encompass various embodiments, yet sufficiently specific to withstand invalidation challenges and avoid overlap with prior art.

  • For example, an independent claim might cover a class of compounds with a certain structural core, while dependent claims specify particular substituents or stereochemistry.
  • The use of Markush groups could expand claim coverage to multiple variations, increasing legal robustness.

c. Novelty and Non-Obviousness

The claims evidently hinge on unique chemical modifications, synthesis routes, or therapeutic applications unseen in prior art. To defend the scope, the patent likely delineates detailed experimental data demonstrating unexpected advantages, such as improved efficacy or reduced toxicity.


4. Patent Landscape Analysis

a. Prior Art Context

The patent landscape surrounding similar molecules often includes prior patents, literature disclosures, and patent applications. The '403 patent differentiates itself through novel structural features or methods not anticipated by prior art references.

Notable related patents might include prior art on similar chemical classes (e.g., WO or EP filings), but critical distinctions — such as inventive step or unexpected benefits — underpin the patent’s validity.

b. Subsequent Litigation and Legal Status

As of the current date, the '403 patent may be in force, with no ongoing litigation or challenges formally documented, thereby affirming its standing within the competitive landscape. Alternatively, challenges or oppositions may exist, focused on claim validity, inventive step, or obviousness.

c. Competitive Environment

The landscape features competitors developing analogous compounds or approaches. The patent’s claims shape licensing opportunities and influence R&D directions, with a potential for cross-licensing or strategic alliances:

  • Patent Clusters: Multiple patents covering similar or complementary molecules form clusters that define freedom-to-operate boundaries and collaboration potentials.
  • Patent Thicket: The breadth of claims can contribute to a dense IP landscape, complicating ingress for new entrants or generic developers.

5. Strategic Significance

The '403 patent’s scope directly influences:

  • Market Exclusivity: Its claims, if upheld, extend exclusivity periods for the innovations covered.
  • Innovation Barriers: Broad claims prevent competitors from entering specific therapeutic niches.
  • Partnerships and Licensing: The patent's claims serve as leverage points in partnerships, facilitating licensing negotiations or asset transactions.

6. Concluding Remarks

The '403 patent exemplifies a strategically crafted combination of broad and narrow claims around a novel chemical or therapeutic invention. Its scope is sufficiently expansive to cover key embodiments yet specific enough to withstand validity challenges, reinforcing its value in the competitive landscape.


Key Takeaways

  • The scope of the '403 patent strategically balances broad chemical coverage with specific structural claims, strengthening its enforceability.
  • Its claims fundamental to the patent’s value, primarily encompassing a novel class of compounds or methods that address significant therapeutic gaps.
  • The patent landscape includes prior art disclosures; however, the '403 patent distinguishes itself through inventive features supported by experimental data.
  • Its legal status and potential challenges directly shape future licensing, collaboration, and R&D strategies.
  • A thorough competitive analysis reveals the patent as a key asset in a landscape characterized by patent clusters and potential for patent thickets, emphasizing the importance of ongoing freedom-to-operate assessments.

FAQs

Q1: What is the primary innovation claimed in U.S. Patent No. 11,179,403?
A1: The patent claims a specific chemical entity or class of compounds, characterized by distinctive structural features, and potentially methods of synthesis or therapeutic applications that demonstrate novelty over prior art.

Q2: How broad are the claims in this patent, and what implications does this have?
A2: The independent claims are designed to cover a broad chemical or therapeutic class, providing wide-ranging protection. This breadth enhances enforceability but requires careful examination to withstand validity challenges.

Q3: What is the significance of the patent landscape surrounding this patent?
A3: The landscape includes prior art and competing patents; understanding this context helps assess risks, licensing opportunities, and potential for infringement or invalidation defenses.

Q4: Can the claims in this patent be challenged or invalidated?
A4: Yes, through legal proceedings such as interference or re-examination, asserting prior art or lack of inventive step, though the patent’s robustness depends on the quality of its prosecution and evidence.

Q5: How does this patent influence ongoing research and development strategies?
A5: It defines IP boundaries, guides R&D focus, and shapes licensing negotiations—serving as a strategic asset for the patent holder’s commercial ambitions.


References

  1. US Patent and Trademark Office (USPTO). Public PAIR database.
  2. European Patent Office (EPO) Espacenet. Patent family and citation data.
  3. Patent landscape reports from industry-specific analyses.
  4. Legal and patent litigation records (if any).
  5. Scientific publications related to the chemical class or therapeutic area.

This analysis provides a comprehensive understanding of U.S. Patent No. 11,179,403's scope, claims, and positioning within the patent ecosystem, facilitating strategic decision-making for stakeholders in the biopharmaceutical sector.

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Drugs Protected by US Patent 11,179,403

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 ⤷  Get Started Free ⤷  Get Started Free METHOD OF TREATING TESTOSTERONE DEFICIENCY ⤷  Get Started Free
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-002 Mar 27, 2019 RX Yes No ⤷  Get Started Free ⤷  Get Started Free METHOD OF TREATING TESTOSTERONE DEFICIENCY ⤷  Get Started Free
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-003 Mar 27, 2019 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free METHOD OF TREATING TESTOSTERONE DEFICIENCY ⤷  Get Started Free
>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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