United States Patent 11,559,501: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,559,501, titled "Transdermal amphetamine compositions with low levels of carbamate," is a significant patent in the field of pharmaceuticals, particularly in the area of transdermal drug delivery systems. This patent, assigned to Noven Pharmaceuticals, Inc., addresses a critical issue in the formulation of transdermal amphetamine compositions.
Patent Overview
Invention Description
This patent describes methods and compositions for reducing the formation of amphetamine carbamate and amphetacarbamate in transdermal amphetamine compositions. The invention focuses on optimizing the formulation to minimize the unwanted by-products that can affect the stability and efficacy of the drug[4].
Claims
The patent includes several claims that define the scope of the invention. These claims typically cover:
- The specific composition of the transdermal amphetamine formulation.
- The methods for preparing these compositions.
- The use of particular polymers and other components to control the formation of carbamates.
- The design of the transdermal delivery system to ensure optimal drug delivery rates and profiles.
Scope of the Patent
Drug Substance and Composition
The patent specifically deals with the formulation of transdermal amphetamine compositions. It outlines the use of certain polymers and other ingredients to reduce the formation of carbamates, which are undesirable by-products that can impact the drug's stability and effectiveness. The scope includes the types of polymers, such as acrylic-based and silicone-based polymers, and the specific monomers used to achieve the desired drug delivery rates[4].
Method of Use
The patent also covers the methods for preparing these transdermal compositions. This includes the process of combining the active ingredient (amphetamine) with the polymer matrix and other components to form a stable and effective transdermal delivery system.
Device and Delivery System
The invention extends to the design of the transdermal delivery device itself. It includes details on how the device is constructed to control the delivery rates, onset, and profiles of the active agent. This ensures that the drug is delivered in a manner that is both effective and safe for the patient[4].
Patent Landscape
Related Patents
The patent landscape in the area of transdermal drug delivery systems is complex and includes several related patents. For example:
- Patent 8,591,941: This patent, also assigned to Noven Pharmaceuticals, Inc., describes a transdermal drug delivery system with a non-drug containing polymeric backing layer that controls the delivery rate and profile of the drug.
- Patent 8,632,802: Another patent from Noven Pharmaceuticals, Inc., this one focuses on a transdermal delivery system using acrylic-based polymers to control drug delivery rates and profiles[5].
Competitive Environment
The competitive environment in this field is highly regulated and competitive. Companies like Noven Pharmaceuticals, Inc. must navigate complex patent laws and regulatory requirements to protect their intellectual property. The listing of patents in the Orange Book, for instance, is crucial for pharmaceutical companies to protect their products and delay the entry of generic competitors[2].
Regulatory Considerations
FDA Regulations
The FDA plays a critical role in regulating pharmaceutical products, including transdermal drug delivery systems. Patents like the one in question must comply with FDA regulations regarding the listing of patents in the Orange Book. This ensures that only patents that claim the drug or its method of use are listed, preventing the improper listing of patents that could delay generic competition[1].
Patent Listing Requirements
The FDA requires that patents listed in the Orange Book must claim the drug for which the applicant submitted the new drug application (NDA). This means that patents related to drug delivery devices or combinations must clearly claim the drug or its method of use to be properly listed[1].
Impact on Innovation and Competition
Innovation
Patents like the one discussed here drive innovation in the pharmaceutical industry by providing incentives for companies to invest in research and development. By protecting the intellectual property related to transdermal amphetamine compositions, Noven Pharmaceuticals, Inc. can recoup its investment and continue to innovate in this area[3].
Competition
The patent landscape affects competition significantly. Generic companies must navigate the patent landscape carefully to avoid infringement. For example, in the case of Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals, the court's decision on whether device patents can be listed in the Orange Book will have significant implications for competition in the pharmaceutical market[2].
Key Takeaways
- Patent Scope: The patent covers specific compositions, methods, and devices for transdermal amphetamine delivery, focusing on reducing carbamate formation.
- Regulatory Compliance: The patent must comply with FDA regulations regarding patent listing in the Orange Book.
- Innovation and Competition: The patent drives innovation and affects competition by protecting intellectual property and delaying generic entry.
- Related Patents: The patent is part of a broader landscape of related patents in transdermal drug delivery systems.
FAQs
What is the main focus of United States Patent 11,559,501?
The main focus of this patent is on methods and compositions for reducing the formation of amphetamine carbamate and amphetacarbamate in transdermal amphetamine compositions.
What types of polymers are used in this patent?
The patent uses acrylic-based and silicone-based polymers to control the formation of carbamates and ensure optimal drug delivery rates.
How does this patent impact competition in the pharmaceutical industry?
This patent protects the intellectual property of Noven Pharmaceuticals, Inc., allowing the company to delay the entry of generic competitors and recoup its investment in research and development.
What are the regulatory requirements for listing patents in the Orange Book?
Patents must claim the drug or its method of use for which the applicant submitted the NDA to be properly listed in the Orange Book.
How does the patent landscape affect innovation in transdermal drug delivery systems?
The patent landscape provides incentives for innovation by protecting intellectual property, allowing companies to invest in further research and development without immediate generic competition.
Cited Sources:
- Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, U.S. Court of Appeals for the Federal Circuit, 2024.
- Drug Delivery Device Patents Removed from Orange Book, JD Supra, 2024.
- Patent Claims and Patent Scope, Hoover Institution, 2016.
- Transdermal amphetamine compositions with low levels of carbamate, Google Patents, 2024.
- Generic Xelstrym Availability, Drugs.com, 2024.
