Details for Patent: 10,226,473

Which drugs does patent 10,226,473 protect, and when does it expire?

Patent 10,226,473 protects TLANDO and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 10,226,473

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 C.sub.max to serum testosterone C.sub.ave 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 C.sub.ave range for a male subject is provided.
Inventor(s):	Giliyar; Chandrashekar (Plymouth, MN), Chickmath; Basawaraj (Minneapolis, MN), Chidambaram; Nachiappan (Sandy, UT), Patel; Mahesh V. (Salt Lake City, UT), Venkateshwaran; Srinivansan (Salt Lake City, UT)
Assignee:	Lipocine Inc. (Salt Lake City, UT)
Application Number:	15/955,429
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Analyzing the Scope and Claims of United States Patent 10,226,473: High-Strength Testosterone Undecanoate Compositions

Introduction

United States Patent 10,226,473, titled "High-Strength Testosterone Undecanoate Compositions," is a patent that covers pharmaceutical compositions and oral dosage capsules containing testosterone undecanoate. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

The patent, issued to a pharmaceutical company, describes high-strength testosterone undecanoate compositions designed for oral delivery. These compositions are formulated to improve the bioavailability and efficacy of testosterone undecanoate, a commonly used treatment for hypogonadism and other conditions related to testosterone deficiency[4].

Scope of the Patent

Claim Structure

The patent includes a series of claims that define the scope of the invention. These claims can be categorized into independent and dependent claims.

• Independent Claims: These claims stand alone and define the broadest scope of the invention. For example, Claim 1 might describe the composition of the pharmaceutical capsule, including the capsule shell and the capsule fill containing testosterone undecanoate.
• Dependent Claims: These claims build upon the independent claims and provide additional details or limitations. For instance, a dependent claim might specify the concentration range of testosterone undecanoate in the capsule fill (e.g., about 14 wt % to about 35 wt %)[4].

Claim Metrics

Research on patent scope often uses metrics such as independent claim length and independent claim count to assess the breadth and complexity of the patent claims. Narrower claims, as measured by these metrics, are generally associated with a higher probability of grant and a shorter examination process[3].

Key Claims and Their Implications

Composition Claims

• The patent claims cover specific compositions of testosterone undecanoate, including the percentage of testosterone undecanoate in the capsule fill. For example, the composition may include about 14 wt % to about 35 wt % testosterone undecanoate based on the total weight of the capsule fill[4].
• These claims also specify the use of solubilizers to enhance the bioavailability of testosterone undecanoate.

Method Claims

• The patent may also include method claims related to the preparation and use of these compositions. This could involve specific steps for manufacturing the capsules or regimens for administering the testosterone undecanoate[5].

Patent Classification

The patent is classified under various categories within the International Patent Classification (IPC) system:

• A61K: Preparations for medical, dental, or toilet purposes.
  • A61K47/00: Medicinal preparations characterized by the non-active ingredients used.
  • A61K47/06: Organic compounds, e.g., natural or synthetic hydrocarbons.
  • A61K47/44: Oils, fats, or waxes according to two or more groups[4].

Prior Art and Novelty

The patent must demonstrate novelty and non-obviousness over prior art. The prior art keywords listed in the patent, such as "testosterone," "testosterone undecanoate," "capsule," and "composition," indicate the existing knowledge in the field that the patent must differentiate from.

International Patent Landscape

Global Dossier

The Global Dossier service provided by the USPTO allows users to access the file histories of related applications from participating IP Offices. This can help in understanding the global patent family for a specific application, including the dossier, classification, and citation data[1].

International Search Resources

To ensure the novelty of the invention, it is crucial to search international patent databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO)[1].

Examination Process

The examination process for this patent would have involved a thorough review by the USPTO to ensure that the claims are clear, definite, and supported by the specification. The process may have included office actions and responses to narrow the scope of the claims if necessary[3].

Practical Implications

Manufacturing and Use

The patent provides detailed instructions on how to manufacture the high-strength testosterone undecanoate compositions. This includes the formulation of the capsule fill and the use of specific solubilizers to enhance bioavailability.

Regulatory Compliance

Companies seeking to use or manufacture these compositions must comply with the patent claims and ensure they do not infringe on the patented invention. This may involve licensing agreements or developing alternative compositions that do not fall within the scope of the patent.

Key Takeaways

• Specific Composition: The patent covers specific compositions of testosterone undecanoate for oral delivery, including the percentage of testosterone undecanoate and the use of solubilizers.
• Claim Structure: The patent includes independent and dependent claims that define the scope of the invention.
• International Classification: The patent is classified under A61K categories, indicating its relevance to medical preparations.
• Global Patent Landscape: Understanding the global patent family and prior art is crucial for ensuring novelty and non-obviousness.
• Examination Process: The patent underwent a thorough examination process to ensure clarity and definiteness of the claims.

FAQs

Q: What is the main subject of United States Patent 10,226,473?

A: The main subject is high-strength testosterone undecanoate compositions for oral delivery.

Q: What are the key components of the claimed compositions?

A: The compositions include a capsule shell and a capsule fill containing about 14 wt % to about 35 wt % testosterone undecanoate and solubilizers.

Q: How does the patent classify under the IPC system?

A: The patent is classified under A61K categories, specifically A61K47/00 and related subcategories.

Q: What resources can be used to search for prior art internationally?

A: Resources include the Global Dossier, European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO) databases.

Q: Why is it important to understand the global patent landscape for this invention?

A: Understanding the global patent landscape helps ensure novelty and non-obviousness over existing patents and applications.

Sources

1. USPTO - Search for patents: https://www.uspto.gov/patents/search
2. USA.gov - U.S. Patent and Trademark Office (USPTO): https://www.usa.gov/agencies/u-s-patent-and-trademark-office
3. SSRN - Patent Claims and Patent Scope: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
4. Google Patents - High-strength testosterone undecanoate compositions: https://patents.google.com/patent/US10226473B2/en
5. Google Patents - Fixed dose oral testosterone undecanoate compositions and use thereof: https://patents.google.com/patent/US12011503B1

Drugs Protected by US Patent 10,226,473

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	10,226,473					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).

International Family Members for US Patent 10,226,473

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
World Intellectual Property Organization (WIPO)	2012075081