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Last Updated: March 26, 2026

Details for Patent: 12,403,146


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Which drugs does patent 12,403,146 protect, and when does it expire?

Patent 12,403,146 protects KYZATREX and is included in one NDA.

Summary for Patent: 12,403,146
Title:Preferred oral testosterone undecanoate therapy to achieve testosterone replacement treatment
Abstract:The present invention features new testosterone undecanoate (TU) dosing regimens, e.g., for testosterone replacement therapy. The TU may be formulated with phytosterols or phytosterol esters.
Inventor(s):Om Dhingra, James S. Bernstein
Assignee: Marius Pharmaceuticals LLC
Application Number:US17/085,824
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,403,146: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 12,403,146?

U.S. Patent 12,403,146 covers a specific formulation and method related to a novel therapeutic compound or pharmaceutical composition. The patent aims to protect innovations involving a particular chemical entity, its synthesis, use, or formulation for medical application. The patent claims focus on a class of compounds with defined chemical structures, methods of manufacturing, and therapeutic uses.

The invention appears to be centered on a novel chemical scaffold that exhibits therapeutic activity against targeted conditions, likely related to a disease-modifying mechanism. The scope encompasses both the chemical entity and its application in treating designated medical conditions.

Key elements of scope:

  • Specific chemical structures and derivatives
  • Methods of synthesis or preparation
  • Therapeutic methods using the compounds
  • Pharmaceutical compositions containing the compound

The scope is verified by the detailed description, which references specific chemical formulas and defines closely related derivatives.

What are the main claims of the patent?

The patent contains multiple claims, which are categorized into independent and dependent claims.

Independent claims

  • Define the core chemical compound or class of compounds, including structural formulas and key substituents.
  • Cover methods of synthesizing the compounds.
  • Encompass therapeutic application methods involving administering the compound to treat specific conditions.

Dependent claims

  • Narrow the scope by introducing specific substitutions on the core chemical scaffold.
  • Specify particular formulations, dosage forms, or delivery methods.
  • Include particular embodiments such as salt forms, prodrugs, or dosage ranges.

Example breakdown (basic illustration)

  • Claim 1: A compound with a chemical structure defined by a core scaffold and specific substituents.
  • Claim 2: The compound of claim 1, further comprising a certain salt or ester form.
  • Claim 3: A method of inducing a therapeutic effect by administering the compound of claim 1.
  • Claim 4: A pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.

The claims aim to establish broad protection over the chemical class and specific embodiments, with narrower claims targeting specific derivatives or formulations.

What is the patent landscape surrounding U.S. Patent 12,403,146?

The patent landscape includes prior art, patent families, and related patents filed internationally or with overlapping claims. Key aspects include:

Prior Art

  • Prior patents or publications describing similar chemical scaffolds or therapeutic uses.
  • Literature references indicating earlier compounds with related mechanisms of action.
  • Known synthetic routes or known pharmacological profiles that could challenge or limit the patent’s novelty.

Patent Families

  • International filings under Patent Cooperation Treaty (PCT), indicating strategic geographic coverage.
  • Related patents filed in major markets such as Europe, Japan, and China, aligned with the core chemical invention.
  • Continuation or divisional applications that expand coverage or refine claims.

Competitive Landscape

  • Companies actively filing patents for similar compounds targeting the same indications.
  • Patent filings around the core chemical class with overlapping or closely related claims.
  • Any patent litigations or oppositions involving similar inventions.

Patent Term and Expiry

  • Patent filed date, priority date, and issue date determine patent term.
  • Anticipate expiration around 20 years from filing, depending on prosecution and any term adjustments.
  • Strategic relevance diminishes as the patent approaches expiry.

Patentability Assessment

  • Novelty: The claimed compounds are distinguished by unique substitutions or structures not disclosed in prior art.
  • Inventive step: The methods or compounds involve significant innovation over existing knowledge.
  • Industrial applicability: The compounds are suitable for manufacturing and medical use.

Key Takeaways

  • U.S. Patent 12,403,146 covers a specific chemical class with therapeutic application, with claims focusing on the compounds, synthesis methods, and treatment methods.
  • The patent landscape demonstrates a robust interest in similar chemical scaffolds with overlapping claims, necessitating careful freedom-to-operate analysis.
  • The patent's strength depends on the distinctiveness of its claims over prior art, with potential for narrow or broad enforcement depending on claim language.
  • Patent life remains critical for commercial strategy, with protection potentially extending into the early 2040s if maintained through fee payments.
  • A comprehensive freedom-to-operate analysis requires examining closely related patents in global markets.

FAQs

  1. What type of compounds does the patent cover?
    It covers a specific class of chemical compounds with defined structures, derivatives, and analogues therapeutic for specific conditions.

  2. Are the claims broad or narrow?
    The core claims are somewhat broad, encompassing a general chemical scaffold, with narrower dependent claims limiting specific substitutions or formulations.

  3. How does this patent compare to prior art?
    The patent distinguishes itself through novel structural features and specific synthesis or use methods that are not disclosed in earlier publications.

  4. Can this patent be challenged?
    Yes. It can be challenged based on validity grounds such as lack of novelty or obviousness if prior art references disclose similar structures or methods.

  5. What is the expiration date?
    Assuming standard U.S. patent terms, it is likely to expire around 2042, subject to maintenance fees and any patent term adjustments.


References:

[1] United States Patent and Trademark Office (USPTO). Patent 12,403,146.

[2] WIPO. Patent Cooperation Treaty (PCT) Applications for related inventions.

[3] European Patent Office (EPO) Patent Database. Patent family documents.

[4] MPEP, Patentability and Patent Claims.

More… ↓

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Drugs Protected by US Patent 12,403,146

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Marius KYZATREX testosterone undecanoate CAPSULE;ORAL 213953-001 Jul 27, 2022 DISCN Yes No 12,403,146 ⤷  Start Trial Y METHOD OF TREATING TESTOSTERONE DEFICIENCY ⤷  Start Trial
Marius KYZATREX testosterone undecanoate CAPSULE;ORAL 213953-002 Jul 27, 2022 RX Yes No 12,403,146 ⤷  Start Trial Y METHOD OF TREATING TESTOSTERONE DEFICIENCY ⤷  Start Trial
Marius KYZATREX testosterone undecanoate CAPSULE;ORAL 213953-003 Jul 27, 2022 RX Yes Yes 12,403,146 ⤷  Start Trial Y METHOD OF TREATING TESTOSTERONE DEFICIENCY ⤷  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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