United States Patent 8,466,137: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,466,137, titled "Testosterone gel and method of use," is a significant patent in the field of pharmaceuticals, particularly for the treatment of testosterone deficiency in males. This patent, issued to Unimed Pharmaceuticals, LLC, and Besins Healthcare Luxembourg SARL, covers an improved transdermal hydroalcoholic testosterone gel formulation.
Background
The patent was granted on May 20, 2014, and is listed in the FDA's Orange Book, which catalogs approved drug products with therapeutic equivalence evaluations. The inventors of this patent are Ramana Malladi and Jodi Stahlman[5].
Scope of the Patent
Formulation
The patent describes an improved transdermal hydroalcoholic testosterone gel formulation. This formulation is designed to enhance the absorption of testosterone through the skin, providing a more effective and stable delivery system. The gel includes ingredients such as isopropyl myristate, glycerine, and propylene glycol, which are crucial for the stability and efficacy of the formulation[1].
Method of Use
The method of use outlined in the patent involves applying the testosterone gel to the skin, typically on the shoulders, upper arms, or abdomen. The application method is designed to ensure consistent and controlled release of testosterone, which is essential for treating conditions associated with testosterone deficiency[1].
Claims of the Patent
Key Claims
The patent includes several key claims that define the scope of the invention:
- Claim 1: A transdermal hydroalcoholic testosterone gel formulation comprising testosterone, a solvent system, and a gelling agent.
- Claim 2: The formulation of claim 1, where the solvent system includes isopropyl myristate and propylene glycol.
- Claim 3: The formulation of claim 1, where the gelling agent is an anionic polymer.
- Claim 4: A method of treating hypogonadism in a male patient, comprising applying the formulation of claim 1 to the skin of the patient[1].
Dependent Claims
The patent also includes several dependent claims that further specify the composition and method of use. These claims detail the concentration of testosterone, the types of solvents and gelling agents used, and the application regimen.
Patent Landscape
Related Patents
The patent landscape surrounding US 8,466,137 includes several related patents that cover similar testosterone gel formulations and methods of use. For example:
- US 8,466,136: Another patent issued to the same assignees, covering a different aspect of the testosterone gel formulation.
- US 8,466,138: A patent that covers additional claims related to the stability and shelf life of the formulation.
- US 8,486,925: A patent that covers specific methods of manufacturing the testosterone gel[5].
Litigation and Infringement
The patent has been involved in litigation, particularly regarding generic versions of AndroGel®. Companies like Watson (now part of Teva Pharmaceuticals) have sought approval for generic versions of AndroGel® 1.62%, which has led to infringement lawsuits. These lawsuits highlight the importance of this patent in protecting the intellectual property rights of the original inventors and assignees[5].
Impact on the Pharmaceutical Industry
Market Dominance
The issuance of US 8,466,137 has contributed significantly to the market dominance of AndroGel® 1.62% in the treatment of testosterone deficiency. The patent's claims and formulation have set a high standard for other testosterone gel products, making it challenging for generic competitors to enter the market without infringing on these patents[5].
Innovation
The patent has driven innovation in the field of transdermal drug delivery systems. The improved formulation and method of use described in the patent have inspired further research and development in pharmaceutical formulations, particularly in the area of hormone replacement therapies.
Expiration and Future Implications
Expiration Date
The patent is set to expire on October 12, 2026, as listed in the Orange Book. This expiration date marks a significant milestone, as it will open the market to generic versions of AndroGel® 1.62%, potentially altering the competitive landscape in the pharmaceutical industry[5].
Generic Competition
Following the expiration of the patent, generic manufacturers will be able to produce and market their own versions of testosterone gel, which could lead to increased competition and potentially lower prices for patients. However, the entry of generics will also depend on the outcome of ongoing litigation and the ability of generic manufacturers to avoid infringing on related patents.
Conclusion
United States Patent 8,466,137 is a critical patent in the pharmaceutical industry, particularly for the treatment of testosterone deficiency. Its scope and claims define a highly effective and stable transdermal testosterone gel formulation. The patent's impact on market dominance, innovation, and future competition underscores its significance.
Key Takeaways
- Improved Formulation: The patent describes an enhanced transdermal hydroalcoholic testosterone gel formulation.
- Method of Use: The method involves applying the gel to specific skin areas for consistent testosterone delivery.
- Claims: Key claims cover the composition and method of use, with dependent claims specifying further details.
- Related Patents: Several related patents cover different aspects of the formulation and method.
- Litigation: The patent has been involved in infringement lawsuits related to generic versions of AndroGel®.
- Impact: The patent has driven innovation and market dominance in hormone replacement therapies.
- Expiration: The patent is set to expire on October 12, 2026, opening the market to generic competition.
FAQs
What is the main subject of United States Patent 8,466,137?
The main subject of this patent is an improved transdermal hydroalcoholic testosterone gel formulation and its method of use.
Who are the inventors of this patent?
The inventors of this patent are Ramana Malladi and Jodi Stahlman.
What is the significance of this patent in the pharmaceutical industry?
This patent is significant because it covers a highly effective and stable testosterone gel formulation, contributing to the market dominance of AndroGel® 1.62%.
What is the expiration date of this patent?
The patent is set to expire on October 12, 2026.
How will the expiration of this patent affect the market?
The expiration will open the market to generic versions of testosterone gel, potentially increasing competition and reducing prices for patients.
Are there any related patents to US 8,466,137?
Yes, there are several related patents that cover different aspects of the testosterone gel formulation and method of use.
Sources
- US8466137B2 - Testosterone gel and method of use - Google Patents
- AndroGel 1.62% Patent Definition - Law Insider
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ... - Insight.RPXCorp.com
