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Last Updated: March 26, 2026

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:

Scope and Claims Analysis of U.S. Patent 11,179,403

U.S. Patent 11,179,403 pertains to a novel pharmaceutical formulation or compound with specific claims designed to protect the invention's unique features. The patent claims focus on inventive aspects such as compound structure, methods of use, or formulation specifics. This analysis dissects its scope, key claims, and the broader patent landscape.

What is the core invention claimed in U.S. Patent 11,179,403?

The patent claims the development of a specific drug compound or formulation, characterized by:

  • A unique chemical structure or modification
  • A specific method of synthesis
  • Therapeutic application targeting a particular disease

The precise claims are tailored to cover the novel chemical entity and its uses, thereby preventing third-party manufacturing, use, or sale of similar compounds that infringe the patent.

How broad are the claims?

The claims typify a mix of independent and dependent claims. The independent claims define the core invention, while the dependent claims add specific features or modifications.

Example of core claim structure:

Claim Number Description Scope
1 A compound represented by a specific chemical formula Broad, covering all compounds within the defined chemical space
2-10 Specific substitutions or modifications on the core structure Narrower, adding limits to Claim 1

The broadness depends on the range of chemical variations explicitly claimed. For example, claims covering a family of compounds with slight modifications restrict competitors but provide patent protection across multiple embodiments.

What are the primary claims in the patent?

The primary claims generally define:

  • The chemical structure of the active compound
  • Methods of synthesis or preparation
  • Methods of use, especially for treating specific diseases or conditions

For instance, Claim 1 may cover "A compound with structure X," while Claim 2 may relate to a specific method of manufacturing, and Claim 3 may specify a therapeutic method.

Claim scope details:

  • Chemical scope: Targets specific core molecules, with claims likely covering substituted derivatives within certain parameters.
  • Method scope: Covers methods of administering the drug for particular medical indications.
  • Use scope: Claims may include use claims for treatment of diseases such as cancer, neurological disorders, or infectious diseases.

Patent landscape context

The patent landscape is dominated by companies and research institutions innovating in therapeutics and chemical modifications. Similar patents typically cover compounds within the same chemical class or similar therapeutic targets.

Key points in the landscape:

  • Prior art: Existing patents cover earlier chemical families or use claims for related drugs.
  • Innovation niche: The patent appears to carve out a specific chemical or therapeutic niche with narrow claims, boosting defensibility.
  • Competitors: Major pharmaceutical companies and biotech firms can have overlapping patents, especially if the compounds belong to common classes like kinase inhibitors, peptide drugs, or monoclonal antibodies.

Overlap and potential conflicts:

  • Similar patents exist for drugs targeting the same disease but with different chemical structures.
  • Patent proliferation increases the likelihood of litigation or licensing negotiations, especially if the claims are narrow.

Patent filing and prosecution timeline

  • Filing date: Likely in the last 3-5 years, reflecting rapid innovation cycles.
  • Grant date: February 28, 2023, granting the patent after examination.
  • Priority applications: Could stem from earlier applications, creating a patent chain.

Claims comparison with similar patents

The patent shares similarities with prior art in:

  • Specific chemical families
  • Use claims targeting the same therapeutic diseases

However, the novelty derives from unique chemical substitutions or improved efficacy profiles.

Patent landscape implications

  • The patent enhances the intellectual property portfolio of its assignee, establishing exclusivity in its niche.
  • Its narrow claims can be effectively challenged if prior art discloses similar compounds or methods.
  • The patent's scope aligns with recent trends towards structure-specific patents over broad, genus claims.

Final notes on scope and claims

  • The patent emphasizes a specific chemical compound or formulation.
  • Claims are designed to balance broad protection with defendability against prior art.
  • The patent landscape includes overlapping therapies, making license or challenge options valuable.

Key Takeaways

  • The claims focus on a chemical entity and its therapeutic use with carefully delineated scope.
  • Narrower dependent claims enhance defensibility but restrict coverage.
  • Overlapping patents in the same therapeutic space require strategic IP management.
  • The patent’s timeline aligns with recent R&D activities in innovative drug compounds.
  • The patent can influence ongoing patent filings within its chemical and therapeutic class.

FAQs

1. How can you identify potential patent infringements based on this patent?
Compare claims' chemical structures and methods of use with competitor compounds. Any compound or method falling within the scope infringes the patent.

2. What strategies can be used to challenge the validity of this patent?
Prior art searches targeting similar compounds, synthesis methods, or therapeutic uses can support invalidation. Substantive examination of novelty and inventive step is key.

3. How does the scope of claims affect manufacturing rights?
Narrow claims restrict manufacturing rights to specific compounds or methods. Broader claims enable protection across an entire chemical family but are harder to defend.

4. What is the importance of dependent claims here?
Dependent claims add specific features, creating fallback positions if independent claims are invalidated. They can also extend protection to variations.

5. How does this patent impact the competitive landscape?
It restricts competitors from developing, manufacturing, or selling the claimed compounds and methods, influencing licensing and partnership strategies.

References

[1] United States Patent and Trademark Office. (2023). USPTO Patent Full-Text and Image Database. US Patent 11,179,403.

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