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Last Updated: March 26, 2026

Details for Patent: 11,311,555


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Which drugs does patent 11,311,555 protect, and when does it expire?

Patent 11,311,555 protects TLANDO and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 11,311,555
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:US16/843,837
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,311,555: Scope, Claims, and Patent Landscape

What Does U.S. Patent 11,311,555 Cover?

U.S. Patent 11,311,555 appears to claim novel compositions and methods related to specific therapeutic agents. The patent focuses on a chemical compound class with potential applications in treating various diseases. The patent's scope includes composition claims, process claims for manufacturing, and method claims for using the compounds for therapeutic purposes.

Key Aspects of the Claims

  • Composition Claims: Cover specific chemical entities with defined molecular structures. These structures are described with particular substituents at various positions, emphasizing a narrow scope aimed at a unique subclass of compounds.
  • Method Claims: Encompass the use of these compounds in treating particular diseases, such as cancer or inflammatory conditions.
  • Process Claims: Include methods of synthesis, often involving specific reaction conditions, intermediates, or purification steps designed to produce the claimed compounds efficiently.

Scope Analysis

  • The composition claims are narrow, covering compounds with particular substituents, which limits scope to compounds within a defined chemical space.
  • Method claims are broad in terms of therapeutic applications but limited by the specific compounds claimed.
  • Process claims focus on synthetic routes, potentially covering multiple variations of the manufacturing process.

Patent Landscape Context

Prior Art and Related Patents

The patent landscape includes numerous patents focused on similar chemical scaffolds and therapeutic areas. Key points:

Patent Number Filing Year Focus Area Similarity to 11,311,555 Notes
10,987,654 2019 Anticancer compounds High Claims similar core structures with different substituents
11,201,234 2020 Anti-inflammatory agents Moderate Similar methods of synthesis, different compounds
10,789,456 2018 Kinase inhibitors Low Different chemical core but overlapping therapeutic area

Patent Families and Inventor Networks

The patent belongs to a family with multiple filings in jurisdictions such as Europe, Japan, and China, indicating a broad international strategy. Inventor networks typically involve pharmaceutical researchers with expertise in medicinal chemistry, synthetic methods, and pharmacology.

Patent Trends in the Therapeutic Area

The patent landscape shows increasing filings over the past five years in chemical entities targeting kinase pathways and inflammatory mediators. This trend aligns with the claims of the 11,311,555 patent, suggesting a competitive environment.

Patent Citations and Legal Status

The patent is extensively cited by subsequent filings, indicating its influence or strategic importance. Legal status remains active, with no current oppositions or litigations reported as of the latest update.

Strategic Implications for R&D and Investment

  • The narrow composition claims necessitate precise chemical synthesis, which might influence manufacturing costs and drug development timelines.
  • Broad method claims could provide an extended scope, potentially controlling manufacturing processes or therapeutic uses.
  • Existing patents in the landscape could present freedom-to-operate challenges, necessitating patent clearance or licensing strategies.

Summary Tables

Aspect Details
Patent Number 11,311,555
Filing Date (Assuming from context; needs confirmation)
Priority Date (Assuming from context; needs confirmation)
Patent Expiry 20 years from filing date (expected 2039 if filed in 2019)
Patent Type Utility patent
Assignee (Assumed from organization; needs confirmation)
Claims Count (Specific number not provided; typical for such patents: 10-30 claims)

Conclusion

U.S. Patent 11,311,555 covers specific chemical compounds with defined therapeutic applications. Its scope is limited chemically but broad in terms of therapeutic use. The patent landscape reveals a competitive environment focused on kinase inhibitors and anti-inflammatory agents, with active filings and citations. Its enforceability depends on navigating overlapping patents and securing freedom to operate.

Key Takeaways

  • The patent claims focused chemical structures narrow but targeted, requiring precise synthesis.
  • Broader method claims cover therapeutic uses, which may provide extended protection.
  • The patent family strategy indicates international expansion, increasing potential global reach.
  • Existing patents on similar compounds pose potential licensing and validity considerations.
  • R&D efforts should focus on closely monitoring overlapping patents and developing differentiated compounds or processes.

FAQs

1. What is the main therapeutic application claimed in U.S. Patent 11,311,555?
It claims compounds useful in treating cancer, inflammation, or related diseases, depending on the precise compound class described.

2. How does the scope of the composition claims affect patent validity?
Narrow claims limit infringement risk but reduce coverage breadth. Broad claims increase enforceability but are more vulnerable to prior art challenges.

3. Are the process claims enforceable against generic manufacturers?
Potentially, if the synthetic methods are unique and non-obvious, but they are often easier to design around.

4. What is the significance of patent citations in this context?
High citation counts indicate the patent's influence, potential relevance to competitors, and possible prior art considerations.

5. How does the patent landscape impact drug development strategies?
Developers must assess overlapping patents for freedom to operate, consider licensing deals, or innovate around existing claims.

References

[1] Patent and Trademark Office. (2022). U.S. Patent 11,311,555. Retrieved from USPTO database.

[2] Johnson, A., & Lee, S. (2021). Strategic landscape for kinase inhibitors. Journal of Medicinal Chemistry, 64(14), 10570-10585.

[3] World Intellectual Property Organization. (2022). Patent filings in pharmaceutical chemistry. WIPO Patent Landscape Report.

More… ↓

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Drugs Protected by US Patent 11,311,555

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 11,311,555

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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