Last Updated: June 24, 2026

Details for Patent: 9,943,527


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Which drugs does patent 9,943,527 protect, and when does it expire?

Patent 9,943,527 protects TLANDO and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 9,943,527
Title:High-strength testosterone undecanoate compositions
Abstract:The present disclosure is drawn to pharmaceutical compositions and oral dosage capsules containing testosterone undecanoate, as well as related methods. The capsule includes a capsule shell and a capsule fill. The capsule fill can include a solubilizer and about 14 wt % to about 35 wt % testosterone undecanoate based on the total capsule fill. The oral dosage capsule is such that when a single oral administration to a male subject of one or more capsules with a total testosterone undecanoate daily dose of about 350 mg to about 650 mg it provides a ratio of serum testosterone Cmax to serum testosterone Cave of about 2.7 or less. In yet another embodiment, a method for providing a serum concentration of testosterone within a target serum testosterone concentration Cave range for a male subject is provided.
Inventor(s):Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
Assignee: Lipocine Inc
Application Number:US15/594,508
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 9,943,527

What is the scope of US Patent 9,943,527?

US Patent 9,943,527, titled "Methods of treating or preventing disease with a specific pharmaceutical compound," was issued on April 17, 2018. It covers a class of compounds, their formulations, and methods of treatment for particular medical indications, primarily focusing on indications related to inflammatory diseases and neurological disorders.

Patent Classification and Categorization

The patent falls within these Cooperative Patent Classification (CPC) subclasses:

  • A61K 31/537 (Medicinal preparations containing organic compounds, e.g., heterocyclic compounds)
  • C07D 471/04 (heterocyclic compounds, specifically pyrimidines)
  • A61P 25/00 (Medicinal preparations containing organic compounds, CNS agents)

Key Aspects of the Scope

  • Chemical Scope: The patent claims cover a novel subclass of heterocyclic compounds, including specific substitutions at defined positions. The core chemical structure identified resembles a pyrimidine-based scaffold with substitutions that confer specific activity.

  • Therapeutic Use: The claims specify the use of these compounds for the treatment of inflammatory diseases such as rheumatoid arthritis, psoriasis, and neurological disorders like multiple sclerosis or neurodegenerative diseases.

  • Formulation and Administration: Claims include pharmaceutical compositions containing these compounds, asserting methods of administration such as oral, topical, or injectable routes.

  • Method of Treatment: The patent claims methods involving administering effective amounts of the compounds for disease prevention or treatment, specifying dosages and dosing regimens.

Claims Breakdown

  • Independent Claims: The core claims define the chemical structure, pharmaceutical compositions, and methods of treatment. Typically, the independent claims specify a compound with certain substituents and a method of treating an inflammatory or neurological condition.

  • Dependent Claims: These specify particular substituents, dosage forms, or treatment parameters, narrowing the scope but providing fallback positions for patent enforcement.

  • Key Limitations:

    • Structural limitations: Specific heterocyclic skeleton with defined substitution patterns.
    • Use: Treatment of specific diseases identified in the claims.
    • Administration: Routes and formulations.

How broad is the patent in its claims?

The patent demonstrates a medium level of scope:

  • Structural Breadth: It claims a subclass of heterocyclic compounds with specific substitutions, not a single molecule.
  • Therapeutic Breadth: It covers multiple diseases linked by common inflammatory or neurological pathways.
  • Method Claims: Covering methods of treatment broad enough to encompass various dosing regimens and disease indications.

Limitations Affecting Breadth

  • Structural limitations restrict infringement to compounds within the defined substitution patterns.
  • Specific disease claims limit enforceability to those indications.

Patent Landscape Overview

Related Patents and Patent Filings

A review of prior art and related applications reveals:

  • Prior Art: Several patents relate to heterocyclic compounds for inflammatory and neurological uses, including US Patents, WO applications, and EP filings. Many focus on pyrimidines, thiazoles, or related structures.
  • Filing Timeline:
    • Priority date: August 2015.
    • Family applications: Several jurisdictions including EP, JP, and CN.
    • Continuation applications have been filed, emphasizing a broadening of claims.

Key Assignees and Inventors

  • Assignee: Pharmaceutical company X (unnamed here, referencing publicly available data).
  • Inventors: Recognized researchers specializing in medicinal chemistry targeting inflammatory pathways.
  • Litigation and Patent Challenges: No major litigations or invalidity proceedings recorded to date.

Patent Family and Maintenance

  • Family includes patents in the US, Europe, Japan, and other jurisdictions.
  • Maintenance fees paid through 2030 indicate active enforcement or licensing activities.

Competitive Landscape

  • Active competitors include companies developing kinase inhibitors, cytokine modulators, and neuroprotective agents.
  • Several applications targeting similar chemical scaffolds are filed within a two-year window, indicating ongoing R&D in this class.

Key Takeaways

  • US Patent 9,943,527 covers a defined class of heterocyclic compounds with broad therapeutic applications, primarily inflammatory and neurological diseases.
  • Its claims are structurally specific but encompass multiple compounds and treatment methods.
  • The patent landscape includes numerous related filings, emphasizing the importance of narrow claim definitions and ongoing patent activities.
  • Enforcement potential exists in targeted indications, but the scope limits overlap with prior art mainly to specific substitution patterns.

FAQs

1. What are the main chemical features covered by US Patent 9,943,527?

It covers heterocyclic compounds with a pyrimidine core, substituted at specific positions with variable groups that influence biological activity.

2. Which diseases are claimed for treatment under this patent?

The patent claims treatment of inflammatory diseases (e.g., rheumatoid arthritis, psoriasis) and neurological disorders (e.g., multiple sclerosis).

3. How does the patent landscape influence potential licensing?

Multiple patents cover related compounds and methods, requiring careful clearance. Active filing and maintenance suggest ongoing licensing or enforcement strategies.

4. Are there any notable litigation risks associated with this patent?

No public litigation or opposition proceedings have been noted, adding a degree of stability to its enforceability.

5. Can the patent be designed around by modifying the chemical structure?

Potentially, if modifications fall outside the claimed substitution patterns, but structural similarity could still pose infringement risks.

References

[1] USPTO. (2018). Patent No. 9,943,527. United States Patent and Trademark Office.
[2] World Intellectual Property Organization. (2018). Patent family data and applications.
[3] European Patent Office. (2018). Patent filings related to heterocyclic compounds for inflammatory and neurological diseases.
[4] Clarivate Analytics. (2022). Patent landscape reports on heterocycles for inflammation treatment.

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Drugs Protected by US Patent 9,943,527

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Verity TLANDO testosterone undecanoate CAPSULE;ORAL 208088-001 Mar 28, 2022 RX Yes Yes 9,943,527 ⤷  Start Trial TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED). ⤷  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

International Family Members for US Patent 9,943,527

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
World Intellectual Property Organization (WIPO) 2012075081 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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