United States Patent 9,358,204: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,358,204, titled "Formulations of viloxazine," is a significant patent in the pharmaceutical industry, particularly for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). This patent, assigned to Supernus Pharmaceuticals, Inc., covers various formulations and methods of administering viloxazine, a drug used to treat ADHD in pediatric patients.
Background
Viloxazine, marketed under the brand name Qelbree, was approved by the FDA on April 2, 2021, for the treatment of ADHD in pediatric patients aged 6 to 17 years[2]. This approval marked a crucial milestone in the regulatory journey of the drug, which involved extensive clinical trials and regulatory reviews.
Patent Overview
Inventors and Assignee
The patent was invented by Michael L. Vieira, Austin B. Huang, and Padmanabh P. Bhatt, and is assigned to Supernus Pharmaceuticals, Inc.[5].
Issue Date and Expiration
The patent was issued on June 7, 2016, and is set to expire on February 7, 2033[5].
Scope of the Patent
Formulations of Viloxazine
The patent primarily focuses on modified release formulations of viloxazine. These formulations include immediate-release (IR) and extended-release (ER) versions, designed to provide a steady and controlled release of the drug over a specified period. The formulations are tailored to achieve a relative steady state area under the viloxazine plasma concentration time profiles for a 24-hour dosing interval (AUCtau)[4].
High-Drug Load Formulations
The patent also discloses high-drug load formulations of viloxazine, which are crucial for ensuring that patients receive the necessary therapeutic dose without the need for multiple tablets or capsules. These formulations are developed using various excipients and polymers such as ethyl cellulose, cellulose acetate, and hydroxypropyl cellulose[1][4].
Claims of the Patent
Composition Claims
The patent includes claims related to the composition of the formulations, including the specific ratios of viloxazine to excipients and the types of polymers used. For example, the patent describes formulations that use ethyl cellulose and cellulose acetate to control the release rate of viloxazine[1].
Method Claims
In addition to composition claims, the patent also covers methods of administering these formulations. This includes specific dosing regimens and instructions for how the drug should be taken to achieve optimal therapeutic effects[4].
Process Claims
The patent further includes claims related to the manufacturing process of these formulations. This involves detailed descriptions of how the pellets, tablets, or capsules are prepared, including coating methods and the use of specific coating agents[1].
Patent Landscape
Related Patents
The patent landscape for viloxazine formulations includes several related patents, all assigned to Supernus Pharmaceuticals, Inc. These patents, such as US Patent 9,603,853 and US Patent 9,662,338, also cover modified release formulations and methods of administering viloxazine. All these patents are set to expire on February 7, 2033[5].
Generic Availability
As of now, there is no therapeutically equivalent generic version of Qelbree available in the United States. This means that Supernus Pharmaceuticals retains exclusive rights to market and sell these formulations until the patents expire[5].
Regulatory Review and Patent Term Restoration
The FDA's approval of Qelbree triggered a regulatory review period that is crucial for determining the eligibility for patent term restoration. The USPTO, with assistance from the FDA, determined that the regulatory review period for Qelbree qualified it for a patent term extension. Supernus Pharmaceuticals has applied for a patent term extension of 785 days, which is subject to statutory limitations and further review[2].
Impact on Innovation and Competition
The breadth and scope of these patents can influence innovation and competition in the pharmaceutical industry. Narrower claims, as seen in this patent, can facilitate a clearer understanding of what is protected and what is not, potentially reducing litigation costs and encouraging further innovation[3].
Key Takeaways
- Formulations and Methods: The patent covers various formulations of viloxazine, including immediate-release and extended-release versions, along with specific methods of administration.
- High-Drug Load: The patent includes high-drug load formulations to ensure therapeutic efficacy.
- Related Patents: Several related patents cover similar aspects of viloxazine formulations.
- Regulatory Approval: FDA approval and subsequent patent term restoration applications highlight the regulatory journey of the drug.
- Generic Availability: No generic version of Qelbree is currently available, maintaining Supernus Pharmaceuticals' exclusive rights.
FAQs
What is the primary focus of US Patent 9,358,204?
The primary focus of US Patent 9,358,204 is on modified release formulations of viloxazine, including immediate-release and extended-release versions.
Who are the inventors of this patent?
The inventors of this patent are Michael L. Vieira, Austin B. Huang, and Padmanabh P. Bhatt.
When is the patent set to expire?
The patent is set to expire on February 7, 2033.
Is there a generic version of Qelbree available?
No, there is currently no therapeutically equivalent generic version of Qelbree available in the United States.
What is the significance of the FDA's approval of Qelbree in relation to this patent?
The FDA's approval of Qelbree triggered a regulatory review period that qualified the patent for a potential term extension, which is currently under review.
Cited Sources
- US9358204B2 - Formulations of viloxazine - Google Patents
- Federal Register, Volume 88 Issue 229 (Thursday, November 30, 2023)
- Patent Claims and Patent Scope - Hoover Institution
- US9358204B2 - Formulations of viloxazine - Google Patents
- Generic Qelbree Availability - Drugs.com
