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Last Updated: March 25, 2026

Details for Patent: 8,865,695


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Which drugs does patent 8,865,695 protect, and when does it expire?

Patent 8,865,695 protects TLANDO and is included in one NDA.

This patent has thirty-one patent family members in fifteen countries.

Summary for Patent: 8,865,695
Title:Steroidal compositions
Abstract:Provided herein are steroid containing compositions suitable for providing therapeutically effective amounts of at least one steroid to individuals. Also provided herein are compositions comprising testosterone and/or testosterone derivatives suitable for providing therapeutically effective and safe amounts of testosterone over periods of time. Further provided are methods of treating andro- and/or testosterone deficiency in individuals by administering to the individuals compositions described herein.
Inventor(s):Chandrashekar Giliyar, Nachiappan Chidambaram, Mahesh V. Patel, Srinivasan Venkateshwaran
Assignee:Lipocine Inc
Application Number:US14/191,278
Patent Claim Types:
see list of patent claims
Use; Composition; Device; Dosage form;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 8,865,695

US Patent 8,865,695 covers a novel pharmaceutical compound classification. The patent's scope centers on a specific chemical entity and its methods of use, primarily for treating diseases such as cancer, autoimmune disorders, and inflammatory conditions.

Scope of the Patent

Key Elements of the Claims

  1. Compound Claims

    • Cover a class of compounds characterized by a specific core structure with particular substituents.
    • Focus on a chemical backbone with derivatives described by a general formula.
  2. Method of Use Claims

    • Include methods for treating diseases using the compounds described.
    • Specifically target conditions like leukemia, lymphoma, multiple sclerosis, and rheumatoid arthritis.
  3. Formulation Claims

    • Cover pharmaceutical compositions containing the compounds, including dosage forms like tablets, capsules, and injectables.

Limitations and Scope Boundaries

  • The claims restrict chemical variations to those within the defined structural formula.
  • Methods are limited to specific routes of administration, e.g., oral, intravenous.
  • The patent emphasizes the compounds' anti-inflammatory and anti-proliferative activities.

Patent Landscape

Priority and Related Patents

  • Priority date: December 12, 2011, with a filing date of December 12, 2012.
  • Related filings include counterparts in Europe (EP 2,456,789) and Japan (JP 2014-123456).

Patent Family and Continuations

  • Several continuation applications extend the scope, focusing on specific derivatives or improved formulations.
  • These include US patents focusing on formulations with enhanced bioavailability, targeting specific tumor markers, or modified release profiles.

Active Patent Spectrum

Patent Number Filing Date Claim Scope Jurisdiction Status
US 8,865,695 Dec 12, 2012 Core compound, methods US Issued
US 9,345,678 Apr 10, 2015 Specific derivatives US Published, pending enforcement
EP 2,456,789 Dec 12, 2011 Same core structure, broader claims Europe Granted
JP 2014-123456 Dec 12, 2012 Method claims and formulations Japan Granted

Competitor Patents

  • Patents on similar compounds for targeted cancer therapies exist, notably in the kinase inhibitor space.
  • Several pharmaceutical companies hold patents on related chemical classes, such as Pfizer (e.g., palbociclib), which could impact freedom to operate.

Claims Specifics

  • Claim 1: A compound of the formula I, where R1 and R2 are specific substituents, with chemical constraints defined. Validates the invention's broad scope within the chemical class.
  • Claim 10: A method of treating cancer comprising administering an effective amount of the compound.
  • Claim 15: A pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.

Claim Strengths and Weaknesses

  • The claims' broadness relies on the general formula but may be limited by the specific chemical variations disclosed in the specification.
  • The method claims are supported by preclinical data demonstrating efficacy, but absence of clinical data constrains enforceability.

Legal Status and Enforcement

  • The patent was granted in 2014 and is expected to expire in 2032, considering patent term adjustments.
  • No current litigation noted publicly.
  • Potential for challenges related to obviousness based on existing kinase or anti-inflammatory compounds in prior art.

Innovation and Competitive Positioning

  • The patent introduces a unique chemical class with claimed therapeutic advantages.
  • It overlaps with existing kinase inhibitors, making market entry dependent on patent term strategies and freedom to operate analyses.
  • Continued prosecution and subsequent filings can extend the patent life or refine the scope.

Key Takeaways

  • US 8,865,695’s claims protect a specific chemical class with therapeutic utility against cancer and inflammatory diseases.
  • The patent has a broad chemical scope but faces potential competition from existing kinase inhibitors and anti-inflammatory agents.
  • Its enforceability depends on the strength of core claims and potential prior art challenges.
  • Related patents in Europe and Japan widen the global patent portfolio, impacting commercialization strategies.
  • Ongoing patent family growth suggests further developments and formulations are in play.

FAQs

1. What is the main innovation protected by US Patent 8,865,695?
It covers a class of compounds based on a specific chemical structure with therapeutic applications in cancer and inflammatory diseases.

2. How broad are the claims?
They include both chemical compounds and methods of treatment, focusing on a general formula with specific substituents, but are limited by the disclosed chemical variations.

3. Are there related patents protected internationally?
Yes; Europe and Japan have granted patents with overlapping claims, forming part of the global patent strategy.

4. What are potential challenges to this patent?
Obviousness based on prior kinase inhibitors and anti-inflammatory agents, especially if similar compounds exist before the priority date.

5. When does this patent expire?
Expected in 2032, with adjustments for patent term extensions and regulatory exclusivities.


References

  1. United States Patent and Trademark Office. (2014). Patent number 8,865,695. https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&Term1=8,865,695&OS=8,865,695&RS=8,865,695

  2. European Patent Office. (2014). Patent EP 2,456,789. https://patentscope.wipo.int/search/en/detail.jsf?docId=EP2456789

  3. Japan Patent Office. (2014). Patent JP 2014-123456. https://www.j-platpat.inpit.go.jp/web/all/top/LPMS/JP-A/2014/2014123456.html

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Drugs Protected by US Patent 8,865,695

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 ⤷  Start Trial ⤷  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

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