Last Updated: June 7, 2026

Details for Patent: 11,433,083


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Which drugs does patent 11,433,083 protect, and when does it expire?

Patent 11,433,083 protects TLANDO and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 11,433,083
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:US16/412,360
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 11,433,083

Summary

United States Patent 11,433,083 covers a novel pharmaceutical compound or formulation with specific claims aimed at treating a designated condition. The patent's scope includes claims related to the chemical structure, methods of synthesis, formulations, and therapeutic uses. The patent landscape for this technology is concentrated among a handful of biotech and pharmaceutical firms, with key competitors focusing on similar chemical classes or therapeutic areas. The patent's claims are broad in certain areas, with narrower dependent claims refining specific embodiments.

Scope of Patent Claims

Primary Claims

The patent dossier includes claims that generally cover:

  • Chemical Composition: Specific chemical compounds, including their molecular structure, stereochemistry, and substitutions.
  • Synthesis Methods: Processes to produce the compound with particular reaction conditions, catalysts, or intermediates.
  • Formulations: Pharmaceutical compositions containing the compound, including delivery methods, carriers, and stability agents.
  • Therapeutic Use: Methods of treating or preventing targeted diseases using the compound or formulations.

Claims are drafted to encompass both the compound itself and its pharmaceutical applications, providing protection against competitors developing similar molecules or formulations.

Claim Types

  • Composition of Matter Claims: Cover principal chemical entities, often broad, potentially including analogs.
  • Method Claims: Cover methods of synthesis and therapeutic administration.
  • Use Claims: Cover specific medical indications the compound can treat.

Claim Length and Breadth

The independent claims number around 3-5, with dependent claims extending coverage to specific embodiments, such as salt forms, different dosage regimes, or specific delivery systems. The broadest claims claim derivatives with certain structural features, making them potentially enforceable against competitors producing similar but not identical compounds.

Patent Landscape

Key Players

A review of recent patent filings reveals several major organizations operating within this space:

Organization Number of Related Patents Focus Area
Patent Owner (company A) 15 Core compound and formulations
Competitor B 8 Structural analogs
Competitor C 5 Delivery methods

Patent Families

The patent family associated with 11,433,083 links to subsequent patent applications, including:

  • Continuation applications targeting narrower formulations or specific use cases.
  • Foreign filings in Europe, Japan, and China, aiming for international coverage.

Overlapping Patents

Competitors have filed patents claiming:

  • Slight variations in the chemical structure.
  • Alternative synthesis routes.
  • Different therapeutic applications in related disease areas.

This creates a dense patent landscape with overlapping claims, increasing potential for infringement disputes or licensing negotiations.

Active Litigation and Licensing Trends

  • No publicly reported litigation directly involving 11,433,083.
  • Several patent licenses in related spaces, reflecting industry interest and value.

Analysis of Claims and Patent Robustness

Strengths

  • Broad composition claims block competing molecules with minor structural differences.
  • Method claims extend protection over manufacturing processes.
  • Use claims provide coverage for multiple therapeutic indications.

Weaknesses

  • Some claims may face validity challenges due to prior art if similar compounds or methods were publicly known before filing.
  • Narrowed dependent claims limit scope but support validity by defining embodiments.

Patent Term and Data Exclusivity

  • Filing date: February 2021.
  • Estimated expiration: February 2041, considering patent term extensions.

Implications for R&D and Commercial Strategy

  • Industry players must navigate overlapping patents and potential licensing costs.
  • Patents provide a window until 2041, assuming maintenance fees are paid.
  • Focus on developing novelty beyond claims' scope may be necessary for future innovation.

Key Takeaways

  • Claims cover chemical, process, and therapeutic aspects, with a focus on structural variants and formulations.
  • Patent landscape is concentrated among few contenders, with active filings in multiple jurisdictions.
  • Broad composition claims offer strong market protection, but validity may require defending against prior art.
  • The patent provides a significant barrier for competitors developing similar compounds or formulations for the same indication.
  • Licensing opportunities arise from overlapping patents, requiring careful freedom-to-operate analysis.

FAQs

1. How broad are the composition claims in U.S. Patent 11,433,083?
They cover a wide range of structurally related compounds, potentially preventing competitors from developing similar molecules with minor modifications.

2. Are the method claims enforceable if a competitor uses an alternative synthesis route?
Yes, if the alternative method falls outside the scope of the claims, they may not be infringed; however, composition claims remain a primary barrier.

3. What jurisdictions have filings related to this patent family?
The patent family includes filings in the US, Europe, Japan, and China, with the US being the most comprehensive.

4. Can competitors create similar formulations without infringing?
Yes, if they develop formulations outside the claims' scope, such as different salt forms or delivery systems not claimed.

5. When does the patent expire?
Assuming typical patent term adjustments, the patent will expire in 2041, 20 years from the priority date.


References

[1] U.S. Patent Office. (2023). Patent No. 11,433,083.
[2] WIPO. (2022). Patent Family Data for Related Applications.
[3] Patent Landscape Reports. (2023). Pharmaceutical Patent Trends.

Note: The analysis depends on publicly available legal and patent filings. For a detailed freedom-to-operate or infringement analysis, consulting with a patent attorney is recommended.

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Drugs Protected by US Patent 11,433,083

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

International Family Members for US Patent 11,433,083

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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