Understanding the Scope and Claims of United States Patent 8,778,373
Introduction
The United States Patent 8,778,373, titled "Methods for controlled release oral dosage of a vitamin D compound," is a significant patent in the field of pharmaceuticals, particularly focusing on vitamin D formulations. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape surrounding it.
Patent Overview
US8778373B2 was granted to protect a stable, controlled release formulation for oral dosing of vitamin D compounds. This patent is part of a series of patents related to vitamin D formulations, highlighting the importance of controlled release mechanisms in pharmaceuticals.
Scope of the Patent
The scope of the patent encompasses several key aspects:
Controlled Release Formulation
The patent describes a method for preparing a controlled release formulation of vitamin D compounds. This involves incorporating one or more vitamin D compounds into a matrix that ensures a sustained release of the active ingredient over a specified period. This is crucial for maintaining therapeutic levels of vitamin D in the body without the need for frequent dosing[1][4].
Ingredients and Composition
The formulation includes various components such as hydroxyvitamin D compounds, waxes, fatty acids, and emulsifying agents. These ingredients work together to achieve a stable and controlled release profile. For instance, the use of waxes like paraffin wax and fatty acids helps in modulating the release rate of the vitamin D compound[1][4].
Manufacturing Process
The patent details the manufacturing process, which involves melting the wax and fatty acid components, mixing them with the vitamin D compound, and then solidifying the mixture to form the final dosage form. This process ensures uniform distribution of the active ingredient and consistency in the release profile[1][4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- The patent claims a controlled release formulation comprising a vitamin D compound and a matrix material that controls the release of the compound.
- It also claims the method of preparing this formulation, including the steps of melting, mixing, and solidifying the components[1][4].
Dependent Claims
- Dependent claims further specify the types of matrix materials, such as waxes and fatty acids, and the proportions in which they are used.
- These claims also detail the specific release profiles and the therapeutic effects achieved by the controlled release formulation[1][4].
Patent Landscape
Related Patents
The patent landscape for controlled release vitamin D formulations is extensive and includes several related patents. For example:
- US8361488B2: This patent also deals with controlled release formulations of vitamin D compounds and shares similarities in the composition and manufacturing process[4].
- US10357502, US11253528, and US9861644: These patents, related to Rayaldee, a drug owned by Eirgen Pharma Ltd., also focus on stabilized modified release vitamin D formulations and their methods of administration. These patents highlight the ongoing innovation in this field and the competitive landscape[2].
Exclusivity and Patent Expiration
The patent US8778373B2 is part of the broader patent portfolio that protects the intellectual property related to vitamin D formulations. The exclusivity period for such patents typically lasts 20 years from the date of filing, but can be extended or shortened based on various factors such as patent infringement litigation or the development of new formulations[5].
Impact on the Pharmaceutical Industry
The controlled release formulation protected by this patent has significant implications for the pharmaceutical industry:
Therapeutic Benefits
- The sustained release mechanism ensures that the therapeutic levels of vitamin D are maintained over a longer period, improving patient compliance and reducing the need for frequent dosing.
- This formulation can be particularly beneficial for patients with vitamin D deficiency or insufficiency, providing a more consistent and reliable treatment option[1][4].
Market Competition
- The patent landscape indicates a competitive market with multiple players innovating in the field of vitamin D formulations. This competition drives innovation and improves the quality of treatments available.
- The expiration of patents like US8778373B2 can open up opportunities for generic versions, potentially increasing access to these treatments[2][5].
Key Takeaways
- US8778373B2 protects a controlled release formulation for vitamin D compounds, ensuring a sustained therapeutic effect.
- The patent details a specific composition and manufacturing process.
- The patent landscape is complex, with multiple related patents and ongoing innovations in the field.
- The therapeutic benefits of controlled release formulations are significant, improving patient compliance and treatment outcomes.
- The exclusivity period and potential for generic versions upon patent expiration are critical factors in the pharmaceutical market.
FAQs
Q: What is the main focus of the US8778373B2 patent?
A: The main focus is on a controlled release formulation for oral dosing of vitamin D compounds.
Q: What are the key components of the controlled release formulation?
A: The formulation includes vitamin D compounds, waxes, fatty acids, and emulsifying agents.
Q: How is the controlled release formulation manufactured?
A: The process involves melting the wax and fatty acid components, mixing them with the vitamin D compound, and then solidifying the mixture.
Q: What are the therapeutic benefits of this controlled release formulation?
A: It ensures sustained therapeutic levels of vitamin D, improving patient compliance and reducing the need for frequent dosing.
Q: When is the patent expected to expire?
A: The patent's exclusivity period typically lasts 20 years from the date of filing, but exact expiration dates can vary based on legal activities and extensions.
Sources
- US8778373B2 - Methods for controlled release oral dosage of a vitamin D compound - Google Patents
- Rayaldee patent expiration - Pharsight
- Patent Claims and Patent Scope - Hoover Institution
- US8361488B2 - Methods and compositions for controlled release oral dosage of a vitamin D compound - Google Patents
- Generic Rayaldee Availability - Drugs.com
