United States Patent 9,603,853: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,603,853, titled "Formulations of viloxazine," is a significant patent in the pharmaceutical field, particularly in the development of modified release formulations of the drug viloxazine. This patent, assigned to Supernus Pharmaceuticals, Inc., was issued on March 28, 2017. Here is a detailed analysis of its scope, claims, and the surrounding patent landscape.
Background on Viloxazine
Viloxazine is a drug with therapeutic applications, notably in the treatment of major depressive disorder and sleep disturbances. However, its weakly basic nature and high in vivo clearance rate present challenges in developing effective formulations[4].
Scope of the Patent
The patent 9,603,853 focuses on the development of modified release formulations of viloxazine. These formulations are designed to overcome the challenges associated with the drug's pharmacokinetic properties.
Modified Release Formulations
The patent discloses various approaches to creating modified release formulations, including:
- Matrix System: This involves embedding the drug in a matrix that controls the release rate.
- Drug-Layered System: This system involves layering the drug on a core material to control release.
- Osmotic Release System: This uses osmotic pressure to release the drug at a controlled rate.
- Gastro-Retentive System: Designed to retain the formulation in the stomach for a longer period, ensuring sustained release[4].
High-Drug Load Formulations
The patent also addresses the development of high-drug load formulations, which are crucial for achieving therapeutic doses while minimizing the number of doses required. This is particularly important given the high therapeutic dose of viloxazine[2].
Claims of the Patent
The claims of the patent are comprehensive and cover various aspects of the formulations and their manufacturing processes.
Key Claims
- Formulation Composition: The patent claims cover the composition of the formulations, including the use of specific polymers such as ethyl cellulose, cellulose acetate, hydroxypropyl cellulose, and polyethylene glycol[1].
- Manufacturing Processes: The claims include methods for preparing the formulations, such as coating processes and the use of specific excipients like glyceryl palmitostearate and hydrogenated vegetable oil[1].
- Release Profiles: The patent claims specify the release profiles of the formulations, ensuring that the drug is released in a controlled manner over a specified period[4].
Patent Landscape
The patent landscape surrounding US 9,603,853 is complex and involves several related patents and exclusivity rights.
Related Patents
Several patents are related to this one, all assigned to Supernus Pharmaceuticals, Inc.:
- US 9,358,204: Issued on June 7, 2016, this patent also deals with modified release formulations of viloxazine.
- US 9,662,338: Issued on May 30, 2017, this patent further discloses methods and formulations for viloxazine[2].
Patent Expiration Dates
All these related patents have the same expiration date: February 7, 2033. This ensures that Supernus Pharmaceuticals, Inc. maintains exclusive rights to these formulations until then[2].
Exclusivity Rights
In addition to patent protection, the FDA may grant exclusivity rights that run concurrently with or independently of patent protection. For viloxazine formulations, such as Qelbree, there is currently no generic version approved, indicating that exclusivity rights are still in effect[2].
Impact on Pharmaceutical Development
The patent 9,603,853 has a significant impact on the development of pharmaceutical formulations, particularly for drugs with challenging pharmacokinetic profiles like viloxazine.
Innovation in Formulations
The disclosed formulations and manufacturing processes represent innovative solutions to the challenges posed by viloxazine. These innovations can be applied to other drugs with similar properties, enhancing the overall efficacy and patient compliance of therapeutic treatments[4].
Competitive Landscape
The patent landscape around viloxazine formulations is highly competitive, with Supernus Pharmaceuticals, Inc. holding a strong position due to its extensive patent portfolio. This makes it challenging for other companies to enter the market with similar formulations until the patents expire[2].
Conclusion
The United States Patent 9,603,853 is a critical patent in the field of pharmaceutical formulations, particularly for viloxazine. It covers a wide range of modified release formulations and manufacturing processes, ensuring that the drug can be delivered effectively despite its challenging pharmacokinetic properties. The patent landscape is complex, with related patents and exclusivity rights that protect Supernus Pharmaceuticals, Inc.'s innovations until 2033.
Key Takeaways
- Modified Release Formulations: The patent discloses various approaches to creating modified release formulations of viloxazine.
- High-Drug Load Formulations: High-drug load formulations are developed to achieve therapeutic doses with minimal dosing.
- Comprehensive Claims: The patent claims cover formulation composition, manufacturing processes, and release profiles.
- Related Patents: Several related patents protect the same innovations, all expiring on February 7, 2033.
- Impact on Pharmaceutical Development: The patent enhances the development of pharmaceutical formulations for challenging drugs.
FAQs
What is the main focus of the United States Patent 9,603,853?
The main focus of the patent is on the development of modified release formulations of the drug viloxazine.
Who is the assignee of the patent?
The assignee of the patent is Supernus Pharmaceuticals, Inc.
What are the challenges associated with viloxazine?
Viloxazine presents challenges due to its weakly basic nature and high in vivo clearance rate.
What types of release systems are disclosed in the patent?
The patent discloses matrix, drug-layered, osmotic release, and gastro-retentive systems.
When do the related patents expire?
All related patents expire on February 7, 2033.
Sources
- US9603853B2 - Formulations of viloxazine - Google Patents
- Generic Qelbree Availability - Drugs.com
- Analysis of Drug Patent in American Universities Based on Xlpat ... - SCIRP
- An Extended-Release Pharmaceutical Formulation of Viloxazine ... - Justia Patents
