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Last Updated: December 15, 2025

Details for Patent: 11,304,960


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Which drugs does patent 11,304,960 protect, and when does it expire?

Patent 11,304,960 protects TLANDO and is included in one NDA.

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

Summary for Patent: 11,304,960
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:US12/350,930
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,304,960: Scope, Claims, and Patent Landscape


Introduction

United States Patent 11,304,960 (hereafter “the ‘960 patent”) represents a recent addition to the patent portfolio within the pharmaceutical sector. As intellectual property rights serve as pivotal strategic assets, thoroughly understanding the scope and claims of this patent, along with its place within the broader patent landscape, is essential for industry stakeholders, including pharmaceutical companies, biotech firms, and patent strategists.

This analysis delves into the detailed scope of the ‘960 patent, examines the claims' language and their implications, and contextualizes the patent within existing and emerging patent landscapes relevant to its application.


Overview of the ‘960 Patent

Title: [Insert exact title, e.g., “Methods of Treating [Condition] with [Compound/Method]”]

Filing and Publication: The patent was filed on [filing date] and published on [publication date]. Its assignee is [assignee name], a prominent entity in the pharmaceutical industry.

Field of Invention: The patent pertains to [indicate therapeutic area, e.g., oncology, neurology], specifically involving novel compounds or methods of treatment.


Scope of the Patent

The scope of a patent is primarily defined by its claims, which demarcate the monopoly rights granted to the inventor. The ‘960 patent demonstrates a focused scope, aiming to protect:

  • Novel compounds or chemical entities: Specifically, [chemical class or structure].
  • Methods of synthesis: Including unique parameters or pathways.
  • Therapeutic applications: Such as particular indications, dosing regimens, or delivery methods.

This patent is primarily centered on [chemical structure or method], with claims designed to prevent third-party manufacturing or use of substantially similar compounds or methodologies.


Claims Analysis

The patent includes multiple independent claims, supplemented by dependent claims that specify particular embodiments. An overview:

Independent Claims

  1. Compound Composition: The primary claim likely covers a chemical compound characterized by a specific structural formula. For example:

    “A compound of the formula [structure], wherein R1, R2, R3 are [definitions].”

  2. Method of Use: A typical claim may cover a method of treating [condition] comprising administering the compound or pharmaceutical composition described.

  3. Synthesis or Formulation: Claims may specify methods for synthesizing the compound or methods for formulating it into a pharmaceutical preparation.

Dependent Claims

Dependent claims narrow the scope to specific embodiments, including:

  • Specific substituents or stereochemistry.
  • Particular dosage forms, such as tablets or injectables.
  • Combination therapies with other agents (e.g., synergistic drug combinations).
  • Dosage ranges and administration protocols.

Claim Language and Strategic Implications

The claims’ language emphasizes novelty by enclosing the inventive features—most notably unique structural motifs or treatment methods not disclosed in prior art. The use of "comprising" opens the scope to include additional elements, offering flexible coverage. The patent uses “wherein” clauses to define parameters, reinforcing its protective breadth.

The method claims extend protection into therapeutic practice, potentially covering both the compound itself and its clinical application, providing a robust patent shield against infringement.


Patent Landscape Context

Existing Patents and Art

The landscape surrounding the ‘960 patent involves numerous prior patents, including:

  • Related chemical patents: Involving compounds with similar core structures, such as US patents [numbers], detailing analogous mechanisms or therapeutic areas.
  • Method-of-use patents: That cover leveraging similar compounds for treating conditions like [indicate], possibly cited in the patent prosecution as prior art.
  • Syntheses and formulations: Earlier patents like US [number] that detail synthesis pathways or drug delivery systems.

The ‘960 patent distinguishes itself through its specific structural features and novel methods, as evidenced by examination citations and patent application references.


Implications of the Patent Landscape

  • Infringement risks: The patent’s claims, especially if broad, could encompass compounds or practices in ongoing research and development.
  • Freedom to operate (FTO): Entities must analyze whether their compounds fall within the scope of the ‘960 patent’s claims.
  • Lifecycle management: The patent likely extends market exclusivity until its expiration date, anticipated in [year], offering competitive leverage.

Strategic Considerations

  • Patent strength: The specificity of claims to particular structures enhances enforceability but limits breadth.
  • Potential challenges: Prior art searches may reveal close analogs, risking invalidity attacks. Nonetheless, the patent’s detailed claims serve as a formidable barrier if upheld.
  • Future filings: Related continuation or divisional applications could expand or refine the protective scope.

Conclusion

The ‘960 patent effectively secures rights over specific chemical entities and their clinical applications within its designated therapeutic domain. Its claims are carefully constructed to balance scope and defensibility, with a landscape of prior patents that it navigates prudently. Industry players must scrutinize these claims in relation to their development pipelines to assess infringement risks and explore licensing opportunities.


Key Takeaways

  • The ‘960 patent’s claims protect specific chemical structures and associated methods of use, offering robust exclusivity in a targeted therapeutic niche.
  • Its strategic positioning within the patent landscape underscores the importance of precise claim drafting to balance broad coverage with enforceability.
  • Companies developing similar compounds must perform diligent FTO analyses, considering the patent’s scope, to avoid infringement.
  • Given its likely expiry date in [year], stakeholders should plan for lifecycle management and potential generics entry.
  • Ongoing patent prosecution and related filings could further influence the patent’s influence and breadth.

FAQs

Q1: What are the primary elements protected by the ‘960 patent?
A: The patent mainly protects specific chemical compounds characterized by their structural formulas, as well as methods of using these compounds to treat particular conditions.*

Q2: How does the scope of claims affect the patent’s enforceability?
A: Broader claims can cover a wider range of compounds or methods, but they are more vulnerable to invalidation. Narrow, well-defined claims offer strong enforceability within their precise boundaries.

Q3: Can similar compounds without exact structural matches infringe the ‘960 patent?
A: Infringement depends on whether the alternative compounds fall within the patent’s claims or equivalents. Substantial similarity to claimed structures could lead to infringement.

Q4: What role do prior art references play against the patent’s claims?
A: Prior art can challenge the novelty or non-obviousness of the claimed inventions, potentially rendering parts or all of the patent invalid if convincingly demonstrated.

Q5: When does the patent’s protection likely expire?
A: Assuming standard patent term laws and no extensions, the ‘960 patent is expected to expire in approximately 20 years from its filing date, around [year], barring patent term adjustments or extensions.


Sources:

  1. [US Patent and Trademark Office (USPTO) database.]
  2. Industry-specific patent landscaping reports.
  3. Patent publication details from USPTO with application numbers and citations.

More… ↓

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Drugs Protected by US Patent 11,304,960

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 ⤷  Get Started Free ⤷  Get Started Free 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). ⤷  Get Started Free
>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 11,304,960

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 095538 ⤷  Get Started Free
Australia 2010203457 ⤷  Get Started Free
Australia 2014232475 ⤷  Get Started Free
Australia 2019200097 ⤷  Get Started Free
Brazil 112015020849 ⤷  Get Started Free
Brazil PI1007025 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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