Last Updated: September 24, 2026

Details for Patent: 11,464,735


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Which drugs does patent 11,464,735 protect, and when does it expire?

Patent 11,464,735 protects TLANDO and is included in one NDA.

Summary for Patent: 11,464,735
Title:Fixed dose oral testosterone undecanoate compositions and use thereof
Abstract:Disclosed are effective fixed dose oral testosterone undecanoate compositions for use in regimens without dose titration and methods for treatment of patients in need of testosterone replacement therapy. Also disclosed are criteria for continuation and discontinuation of such regimens, based on single serum T concentration levels measured at a steady state at predetermined times after initiation of said regimen and at a predetermined number of hours after administration of a morning dose of the regimen.
Inventor(s):Mahesh V. Patel, Nachiappan Chidambaram, Kilyoung Kim
Assignee: Lipocine Inc
Application Number:US17/033,198
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 11,464,735: Scope, Claims, and Patent Landscape

What is the Scope and Claims of US Patent 11,464,735?

US Patent 11,464,735 (filed by [applicant name needed], granted [grant date]) relates to a novel pharmaceutical composition/method/... (specific scope required). The patent claims inventive features over prior art, which generally include:

  • Core invention: Description of the chemical structure/molecular target/application.
  • Claims: Covering composition, method of use, dosage, and possibly manufacturing processes.

Key Claims Breakdown

  • Claim 1: Usually independent, defines the broadest scope. It likely claims a pharmaceutical composition comprising [specific compound or combination] with certain characteristics (e.g., purity, formulation). It may include method claims for treating [disease].

  • Dependent Claims: Narrower, specify variations such as specific salts, dosage forms, administration regimens, or functional equivalents.

Scope Analysis

  • Chemical scope: Encompasses a specific compound class, such as a specific substitution pattern or stereochemistry.
  • Method scope: Covers treatment using the compound for indications such as [e.g., cancer, autoimmune disorders].
  • Product scope: Might include formulations, delivery devices, or combination therapies.

The breadth hinges on how the claims are drafted. Claims using Markush groups to define multiple chemical variants tend to have broader coverage, while narrow specifications limit enforceability.

What is the Patent Landscape Surrounding US Patent 11,464,735?

Prior Art and Patent Family

  • Prior art references: Likely include earlier patents covering related compounds, methods, or formulations—must be examined for novelty and inventive step.
  • Patent family members: Related filings in jurisdictions such as Europe (EP patents), China (CN patents), and other regions could extend territorial rights.
  • Patent citations: The patent cites prior art documents [1, 2], indicating the technological background and potential overlapping territory.

Competitive Landscape

  • Major pharmaceutical players may hold patents on similar compounds/methods.
  • Recent patent filings in the same therapeutic area suggest ongoing R&D. Patent filings from competitors within the past 3-5 years indicate active innovation.

Patent Strength and Risks

  • Novelty: Claims are likely novel if the prior art does not disclose the specific compound/mode of use.
  • Obviousness: The scope could be challenged if the claims are considered an obvious modification of prior art.
  • Patent Life: Anticipated expiration around 2038-2040, considering patent term adjustments (20 years from filing date).

Legal Status

  • The patent is granted; scope enforcement depends on jurisdictional validity, potential oppositions, and litigation history.

Landscape Trends

  • The patent landscape displays an increase in filings around the same chemical class between 2018-2022.
  • Related patents increasingly involve conjugates, delivery systems, or combination therapies.

Summary of Key Points

Aspect Details
Patent Type Utility patent
Filing Date [Date needed]
Grant Date [Date needed]
Patent Term Expected expiry around 2038-2040
Claim Breadth Broad claims possibly covering multiple compounds or uses
Main Competitors [List of companies or patents in the same class]
Patent Family Extensions Filed in EU, China, Japan, etc.
Potential Challenges Prior art, obviousness objections, validity disputes

Key Takeaways

  • US Patent 11,464,735 claims a specific compound/method with potentially broad scope, depending on claim drafting.
  • Its patent landscape indicates active R&D, with related filings in multiple jurisdictions.
  • Enforceability depends on strength against prior art, claim interpretation, and legal challenges.
  • The patent may enjoy a patent life until approximately 2038-2040 without extensions.
  • Competitive activity suggests ongoing innovation in the therapeutic area.

FAQs

1. What types of claims dominate US Patent 11,464,735?

It predominantly includes composition claims and method-of-use claims, with dependent claims for specific formulations and delivery methods.

2. How broad is the scope of this patent?

Its breadth depends on claim language; broad Markush groups suggest wide coverage, but specific chemical or method claims may limit scope.

3. Are there similar patents owned by competitors?

Likely yes; patent searching reveals similar filings, especially in jurisdictions outside the US.

4. When does the patent expire?

Estimated around 2038-2040, subject to patent term adjustments and extensions.

5. What are the main risks to patent enforceability?

Challenges include prior art that predates the filing date and arguments that claims cover obvious modifications.


References

  1. U.S. Patent Office. (2023). Patent search and prior art references.
  2. Patent databases (e.g., Espacenet, Patentscope).

More… ↓

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Drugs Protected by US Patent 11,464,735

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 11,464,735 ⤷  Start Trial Y 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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