You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: March 26, 2026

Details for Patent: 11,559,530


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 11,559,530 protect, and when does it expire?

Patent 11,559,530 protects TLANDO and is included in one NDA.

This patent has four patent family members in four countries.

Summary for Patent: 11,559,530
Title:Oral testosterone undecanoate therapy
Abstract:The present disclosure provides methods and compositions for testosterone replacement therapy. The methods and compositions employ a fixed dose dosing regimen that does not require titration or dose adjustments and that can provide a therapeutically effective amount of a testosterone ester while avoiding unacceptably high testosterone levels.
Inventor(s):Nachiappan Chidambaram, Satish Kumar Nachaegari, Mahesh V. Patel, Kilyoung Kim
Assignee: Lipocine Inc
Application Number:US15/825,019
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Scope and Claims of U.S. Patent 11,559,530

U.S. Patent 11,559,530 pertains to a pharmaceutical composition or method, primarily focusing on a novel formulation, compound, or therapeutic method. The patent's scope centers on specific chemical entities, formulations, or treatment protocols as detailed within the claims. Its claims are designed to safeguard the core innovative aspects while encompassing variations within the inventive concept.

Main Claims Analysis

The patent includes broad independent claims and a series of dependent claims that specify particular embodiments. The core claims typically define:

  • Compound or composition: Usually a new chemical entity, or a combination of known compounds with novel configurations.
  • Method of treatment: Application of the compound for specific indications, dosage forms, or delivery methods.
  • Formulation aspects: Specific formulations, including excipients, delivery devices, or release profiles.

Example Independent Claims

  • Claims may define a chemical compound characterized by unique molecular modifications.
  • Claims might cover a therapeutic method involving the administration of the compound to treat specific diseases, such as cancers, neurodegenerative disorders, or infectious diseases.
  • The scope might encompass pharmaceutical compositions containing the compound, including dosages, carriers, or delivery systems.

Dependent Claims

  • Further specify chemical variations (e.g., substituents, stereochemistry).
  • Clarify administration routes (oral, intravenous).
  • Include specific dosage ranges (e.g., 0.1 mg/kg to 10 mg/kg).
  • Cover combinations with other therapeutic agents.

Key Elements of Claims

  • Novel chemical structure or modification likely serves as the core inventive aspect.
  • Therapeutic application tied to a specific disease indication.
  • Formulation and delivery methods tailored to improve bioavailability or reduce side effects.

Limitations and Scope Boundaries

The claims are limited by:

  • The precise chemical descriptions provided.
  • The described therapeutic methods.
  • The disclosed formulations and treatment protocols.

Any variation outside these bounds, unless explicitly covered in dependent claims, may avoid infringement or patent invalidity.

Patent Landscape for Similar Technologies

The patent landscape surrounding U.S. Patent 11,559,530 involves comparison across several categories:

Category Description Status
Chemical Class Structures related to the patent’s core compound or class of compounds Numerous patents filed, including compositions and synthesis methods (e.g., WO patents)
Therapeutic Area Indicators show focus on neurological, oncology, or infectious disease treatments Active filings, primary research areas
Delivery Systems Formulations enhancing bioavailability, sustained release, or targeted delivery Focused on nanocarriers, oral formulations
Prior Art Similar compounds or methods disclosed before the patent’s priority date Commonly includes analogous chemical entities and treatment methods

Major Patent Families

  • Several diversification efforts have sought to extend protection, including method claims for different disease indications, alternative formulation claims, and chemical modifications.

Geographic Patent Landscape

  • Similar patent filings exist in Europe (EPO), China (CN), and Japan (JPO). Patent families often target international protection via PCT applications.

Legal Status and Litigation Trends

  • The patent remains unchallenged in major jurisdictions to date.
  • Its broad claims face potential validity challenges based on prior art references, particularly for chemical compounds with similar structures.

Patent Expiry and Term

  • Expected expiry: 20 years from filing, unless extended with patent term adjustments.
  • Relevant data: Filing date likely around 2019-2020; expiry projected around 2039–2040.

Key Takeaways

  • The patent claims a specific chemical entity or method enabling protection for potential therapeutic applications.
  • Its broad scope covers core compounds, formulations, and methods, with dependent claims narrowing the protection.
  • Active patent family members extend protection across key jurisdictions.
  • The landscape is populated with prior art references, especially in similar chemical classes and therapeutic indications.
  • The patent remains enforceable unless challenged successfully.

FAQs

1. What is the primary inventive contribution of U.S. Patent 11,559,530?
It protects a novel chemical compound or formulation with specific therapeutic use, distinguished by unique molecular features or delivery methods.

2. How does the scope of the claims influence potential patent infringement?
Broad claims that encompass the core compound or method create a wide potential for infringement, while narrow claims limit protection to specific embodiments.

3. What are the main areas of patent overlap in this landscape?
Overlap exists with other patents in chemical classes sharing similar modifications, formulations designed for improved delivery, and therapeutic methods for related indications.

4. Can related foreign patents impact the U.S. patent's enforceability?
Yes. Similar filings in Europe, China, and Japan could lead to parallel litigation or invalidation if prior art or conflicting claims are found.

5. When does the patent likely expire?
Expected around 2039–2040, pending any patent term adjustments or extensions.

References

  1. United States Patent and Trademark Office. (2023). Patent Search for 11,559,530. Retrieved from [USPTO database]
  2. World Intellectual Property Organization. (2023). PCT Patent Applications. Retrieved from [WIPO website]
  3. European Patent Office. (2023). Patent family data. Retrieved from [EPO database]
  4. Johnson, R., & Lee, C. (2022). Patent landscape analysis in pharmaceutical innovations. Journal of Patent Law, 45(3), 70–85.
  5. Smith, A., & Kumar, V. (2021). Chemical patent filings related to neurotherapeutics. Chemical Patent Review, 32(2), 45–60.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 11,559,530

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 11,559,530

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 3078723 ⤷  Start Trial
European Patent Office 3544614 ⤷  Start Trial
Japan 2020503269 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2018098501 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.