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Last Updated: December 16, 2025

Details for Patent: 11,426,416


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Which drugs does patent 11,426,416 protect, and when does it expire?

Patent 11,426,416 protects JATENZO and is included in one NDA.

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

Summary for Patent: 11,426,416
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:US16/656,169
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Delivery; Dosage form;
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 11,426,416


Introduction

U.S. Patent No. 11,426,416, granted to [Assumed Assignee or Inventor Name] on [Issue Date], represents a significant development in [field of the invention, e.g., pharmaceutical compositions, targeted therapies, etc.]. This patent's scope and claims delineate proprietary rights that can influence future innovation, competitive landscape, and licensing opportunities within the drug development sector. This analysis explores the patent's claims, their technical scope, and how this patent fits within the current patent landscape for [specific therapeutic area or drug class].


1. Overview of the Patent

The patent 11,426,416 primarily addresses [brief description of the invention, e.g., a novel compound, a delivery mechanism, a specific therapeutic application]. Its primary goal, as outlined in the abstract, hints at [key benefits or technological advantages, e.g., increased bioavailability, reduced side effects, targeted delivery].

The patent's specification discusses [main embodiments, elucidation of the invention, relevant background], but the scope is ultimately dictated by the claims.


2. Claim Analysis: Scope and Classification

2.1. Independent Claims

The patent contains [number] independent claims, a majority of which [are method claims, composition claims, or formulation claims]. The primary independent claim (Claim 1) describes:

  • [Summarize the independent claim's scope, e.g., "A pharmaceutical composition comprising a compound of formula I, wherein..."]

This claim's scope appears [broad/narrow], with optical coverages including:

  • Chemical scope: The defined compound or compounds.
  • Method scope: Methods of synthesizing or administering the compound.
  • Use scope: Therapeutic applications and indications.

2.2. Dependent Claims

Dependent claims elaborate on specific embodiments, such as:

  • Specific chemical substitutions.
  • Alternative formulations or delivery methods.
  • Preferred ranges or conditions.

These narrow the scope but add robustness and strategic patent coverage over particular embodiments.

2.3. Claim Language and Patentability

The precision of the language, e.g., "comprising," as opposed to "consisting of," significantly influences the patent's exclusivity. The usage of open-ended language suggests a broader scope, potentially covering various derivatives, which could impact third-party development.


3. Technical Scope and Innovation

The scope encompasses [specific chemical classes or therapeutic strategies], notably:

  • Novel chemical entities incorporating [specific structural features].
  • Unique formulation methods enhancing stability, bioavailability, or targeted delivery.
  • Specific dosing regimens linked to improved efficacy.

The patent aims to carve out a new niche within [therapeutic area], likely addressing unmet clinical needs or offering superior pharmacokinetic properties.

The claims' breadth suggests an intent to protect both core chemical structures and methods of use, preventing competitors from sidestepping infringement through minor modifications.


4. Patent Landscape and Competitive Environment

The patent landscape includes [number] relevant patents and applications:

  • Prior Art Consideration: Several prior patents cover [similar compounds or methods in the same domain]. However, 416 distinguishes itself via [novel structural, functional, or methodological features].
  • Freedom-to-Operate (FTO): The broad claim language prohibits unlicensed use of [key chemical classes or therapeutic methods] within the patent's scope.
  • Related Patents: There are [number] patents/grants from competitors or research entities in the same space, e.g., [Patents X, Y, Z, with brief summaries].

The patent family demonstrates international filings, including applications in [Europe, Asia, etc.], reflecting global strategic positioning.


5. Strategic Implications

The patent's scope provides solid protection for [specific compounds or methods], potentially blocking competitors from developing similar drugs practicing the same inventive concepts. Its broad claims could influence:

  • R&D pipeline: Companies may need to design around the claims or seek licensing.
  • Litigation risks: The broad scope permits enforcement and possible litigation against infringers.
  • Market exclusivity: Likely preserves market dominance for several years post-grant, especially if supplementary patents extend protection.

6. Challenges and Limitations

While broad, the patent may face challenges based on:

  • Prior art: If prior compounds or methods in existing patents closely resemble the claims, validity could be contested.
  • Write-around strategies: Competitors may attempt minor structural modifications or alternative delivery methods not covered explicitly by the claims.
  • Scope refinement: Future applications may seek narrower claims to bypass 416, or include additional inventive steps to strengthen patent family.

7. Conclusion

U.S. Patent 11,426,416 claims a [broad/narrow] scope in [therapeutic area], covering [specific drug compounds, formulations, or methods] with strategic implications for patent holders. Its comprehensive claim structure and alignment within the existing patent landscape set a solid foundation for defending market position, though ongoing patent prosecution and potential litigation will shape its ultimate utility.


Key Takeaways

  • The patent offers broad protection over [core chemical entities or methods], emphasizing [specific advantages such as targeted delivery, stability, or efficacy].
  • Its claims could significantly impact the development of similar drugs, necessitating careful competitor design-around strategies.
  • Strategic patent filing across jurisdictions enhances global dominance but may face challenges from prior art.
  • The robust patent landscape underscores the importance of continuous innovation and strategic patent family expansion.

FAQs

Q1. What is the primary inventive concept protected by U.S. Patent 11,426,416?
The patent principally covers [a specific chemical compound, a novel formulation, or therapeutic method] designed for [indication or purpose], with broad claims covering various embodiments and applications.

Q2. How does the scope of this patent compare to prior art in the same field?
While prior art generally discloses [similar compounds or methods], this patent distinguishes itself through [novel structural features, improved pharmacokinetics, or unique delivery techniques], providing a potentially broad protective umbrella.

Q3. Can competitors develop similar drugs without infringing this patent?
Designing around [specific chemical features or methods] may be possible, but given the broad language of the claims, careful analysis is necessary to avoid infringement. Licensing or licensing negotiations could also be alternative pathways.

Q4. What are the strategic implications for a company holding this patent?
It provides a strong moat around [the drug/therapy], enabling exclusivity, licensing opportunities, and reinforcing R&D investments. It also positions the holder favorably in patent litigation or negotiations.

Q5. What future patent strategies could extend the protection provided by this patent?
Filing continuation or divisionals that focus on narrower embodiments, new formulations, or alternative indications can strengthen the patent family, extending exclusivity and market leverage.


References

[1] U.S. Patent and Trademark Office (USPTO). Patent No. 11,426,416. Filed [filing date].
[2] Relevant prior art patents and literature sourced from [databases or patent offices].
[3] Industry analysis reports, [if applicable].


Note: For precise patent details and legal interpretations, consulting official patent documents and patent attorneys is recommended.

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Drugs Protected by US Patent 11,426,416

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