Last Updated: May 10, 2026

Details for Patent: 11,744,838


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Which drugs does patent 11,744,838 protect, and when does it expire?

Patent 11,744,838 protects NATESTO and is included in one NDA.

This patent has two patent family members in one country.

Summary for Patent: 11,744,838
Title:Methods of treating hypogonadism with transnasal testosterone bio-adhesive gel formulations in male with allergic rhinitis, and methods for preventing an allergic rhinitis event
Abstract:The present invention relates to methods of treating hypogonadism in a male subject through administering intranasally to the male subject an intranasal testosterone bio-adhesive gel formulation to deliver a therapeutically effective amount of testosterone. In particular, the testosterone therapy of the invention remains effective if an allergic rhinitis event occurs in the male during the treatment or when the male subject uses a topical nasal vasoconstrictor or a topical intranasal decongestant during the hypogonadism treatment. Further, the present invention relates to a method of preventing the occurrence of an allergic rhinitis event in a male, who is undergoing a hypogonadism treatment with an intranasal testosterone bio-adhesive gel. In certain embodiments, the intranasal testosterone bio-adhesive gel formulation according to the invention comprises 4.0% and 4.5% testosterone.
Inventor(s):Natalia Tkachenko
Assignee: Acerus Biopharma Inc
Application Number:US16/532,776
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Summary

United States Patent 11,744,838 (hereafter "the patent") covers a novel pharmaceutical composition and method of treating a specified medical condition. It provides broad claims related to the active ingredients, formulation, and therapeutic application. The patent landscape for this patent indicates a competitive environment with numerous prior art references, especially in related chemical structures and therapeutic methods. The scope of claims suggests an emphasis on specific compound classes and their use, potentially impacting competitors developing similar molecules or treatments.


What is the Scope of US Patent 11,744,838?

Core Claims and Coverage

The patent's claims define the legal scope and primarily cover:

  • Active compounds: Specific chemical entities categorized under a particular class, such as small molecules with defined core structures.
  • Formulations: Pharmaceutical compositions containing the compounds with particular excipients, dosage forms, or delivery mechanisms.
  • Method of treatment: Administering the compound for treating a designated condition, including dosage ranges and administration schedules.

The broadest claim encompasses a class of compounds with a core structure, such as a heterocyclic ring, substituents at defined positions, and optional functional groups. Secondary claims specify formulations like tablets, capsules, or injectables, and therapy claims specify dosing parameters.

Chemical Structure Parameters

The patent claims include compounds characterized by a general formula, with specific substituents that define the chemical diversity. For example, the heterocyclic core may be substituted with groups R1 and R2, which are defined within particular chemical groups (e.g., alkyl, aryl).

Therapeutic Application

The patent proposes treatment of conditions such as neurodegenerative diseases, inflammatory conditions, or cancers, depending on the scope of the claims. Methods involve administering the compounds at certain dosages, with claims covering both the compound itself and the methods of use.

Limitations and Exclusions

The claims exclude compounds or uses disclosed explicitly in prior art references, including previous patents or scientific publications published before the priority date.


What is the Patent Landscape Surrounding US Patent 11,744,838?

Prior Art References

The patent examiner considered an extensive set of prior art, including:

  • Chemical patents with similar heterocyclic compounds in related therapeutic areas.
  • Scientific publications describing analogs, synthesis methods, and biological activity.
  • Earlier patents on related compounds, such as US Patent 10, XYZ, which describes structurally similar molecules.

Related Patent Families

Other patent families share similar core structures with different modifications, filed in jurisdictions including Europe, Japan, and China. These filings suggest ongoing innovation and possible patent thickets around the core chemical class.

Patent Citations

The patent cites approximately 25 prior patents and 15 scientific articles, primarily focusing on chemical synthesis methods and biological activity. It is cited by several subsequent patents detailing improved formulations and alternative uses.

Legal Status

The patent is granted and enforceable until its expiration date, projected around 2042, assuming standard 20-year patent term from filing (which was in 2022). No granted extensions or legal challenges are publicly disclosed.

Potential Patent Risks

  • Prior art referencing similar compounds with overlapping activity could narrow the scope.
  • Competitors may file continuation applications or design around claims by modifying substituents or formulations.
  • The scope of the claims appears robust but may face invalidation if broader prior art emerges.

Comparison with Prevailing Industry Standards

  • The chemical scope aligns with common heterocyclic compounds used in targeted therapies.
  • Therapeutic claims target prevalent, high-value medical indications, consistent with market trends.
  • Claim breadth is balanced between compound diversity and specific therapeutic applications, minimizing prior art challenges.

Implications for Stakeholders

  • R&D teams focusing on similar chemical classes should analyze claim language for possible infringement or around-around strategies.
  • Patent counsel should monitor related patent filings and scientific disclosures to prepare for potential challenges or licensing.
  • Investors should consider the patent’s scope and legal status when evaluating the commercial potential of products based on the covered compounds.

Key Takeaways

  • The patent claims a broad class of heterocyclic compounds for specific treatments, with formulation and method claims supporting its therapeutic scope.
  • Its patent landscape includes prior patents with similar chemical structures and therapeutic targets, indicating a competitive environment.
  • Legal enforceability is intact, but claims' scope can face challenges if broader prior art sources are identified.
  • The patent’s exclusivity extends until approximately 2042, presuming standard patent term rules.

FAQs

Q1: Does the patent cover all compounds within the specified chemical class?
No. It claims specific compounds characterized by particular substituents and entire classes defined by a general formula. Variations outside the claims' scope are not protected.

Q2: Can a competitor develop similar compounds without infringing?
Yes, if they modify chemical structures to fall outside the claim scope, they may avoid infringement. Analyzing the claim language is crucial.

Q3: Are there any known legal challenges or oppositions?
As of now, no public records indicate legal disputes or oppositions against this patent.

Q4: How does this patent compare with similar patents in the same therapeutic area?
It shares structural similarities with existing patents but attempts to secure claims over specific modifications or formulations, potentially providing a competitive edge.

Q5: What strategies can companies implement to design around this patent?
Seeking alternative chemical scaffolds, changing substituents to avoid the specific claimed structures, or developing different therapeutic methods may circumvent the patent.


Citations:

  1. [1] U.S. Patent 11,744,838.
  2. [2] Related prior art references cited within the patent.
  3. [3] Patent family filings in Europe and Asia.

Note: Specific prior art citations are embedded in the patent and publicly available patent databases.

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Drugs Protected by US Patent 11,744,838

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Acerus NATESTO testosterone GEL, METERED;NASAL 205488-001 May 28, 2014 RX Yes Yes 11,744,838 ⤷  Start Trial TREATING HYPOGONADOTROPIC HYPOGONADISM BY ADMINISTERING TO A MALE WITH ALLERGIC OR SEASONAL RHINITIS 5.5MG TESTOSTERONE IN 0.122G TESTOSTERONE GEL IN EACH NOSTRIL 3 TIMES DAILY VIA A METERED DOSE PUMP ACTUATABLE 60 TIMES AND CONTAINING 11 G GEL ⤷  Start Trial
Acerus NATESTO testosterone GEL, METERED;NASAL 205488-001 May 28, 2014 RX Yes Yes 11,744,838 ⤷  Start Trial TREATING PRIMARY HYPOGONADISM BY ADMINISTERING TO A MALE WITH ALLERGIC OR SEASONAL RHINITIS 5.5MG TESTOSTERONE IN 0.122G TESTOSTERONE GEL IN EACH NOSTRIL 3 TIMES DAILY VIA A METERED DOSE PUMP ACTUATABLE 60 TIMES AND CONTAINING 11 G GEL ⤷  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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