United States Patent 10,300,078: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,300,078, titled "Stabilized modified release vitamin D formulation and method of administering same," is a significant patent in the field of pharmaceuticals, particularly concerning vitamin D formulations. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
Vitamin D is a crucial nutrient for bone health and overall well-being. However, its stability and bioavailability can be challenging, especially in pharmaceutical formulations. The patent in question addresses these issues by introducing a stabilized modified release formulation of vitamin D.
Scope of the Patent
The patent focuses on a stabilized formulation designed for the controlled release of vitamin D compounds, specifically 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3. This formulation is engineered to enhance the stability and bioavailability of these compounds, which is critical for therapeutic efficacy.
Key Components
- Active Ingredients: The formulation includes one or both of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3.
- Stabilizers: The patent specifies the use of various stabilizers to maintain the integrity of the vitamin D compounds over time.
- Release Mechanism: The formulation is designed for modified release, ensuring a controlled and sustained delivery of the active ingredients[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 describes the stabilized formulation comprising 25-hydroxyvitamin D2 or 25-hydroxyvitamin D3, along with specific stabilizers and excipients.
- Claim 2 outlines the method of administering the formulation, emphasizing the controlled release aspect[4].
Dependent Claims
- These claims further specify the types of stabilizers, excipients, and the manufacturing process involved in creating the formulation.
- They also detail the physical form of the formulation, such as tablets, capsules, or other oral dosage forms[4].
Patent Landscape
The patent landscape surrounding US 10,300,078 is complex and involves multiple related patents and legal activities.
Related Patents
- US10357502 and US11253528: These patents also pertain to stabilized modified release vitamin D formulations and share similar claims and expiration dates (March 2034)[2].
- US9498486 and US9408858: These patents are related to the same drug (Rayaldee) and involve different aspects such as dosage and administration methods[2].
Patent Expiration and Generic Launch
The patents protecting the stabilized modified release vitamin D formulation are set to expire in March 2034. This expiration date is crucial for the potential launch of generic versions of the drug, which could significantly impact the market[2].
Legal Activities
Recent legal activities include the payment of maintenance fees and the recordation of patent grants. These activities indicate ongoing efforts to maintain the patent's validity and protect the intellectual property[2].
Impact on the Pharmaceutical Industry
The stabilized modified release vitamin D formulation has several implications for the pharmaceutical industry:
Therapeutic Efficacy
- The controlled release mechanism ensures a sustained therapeutic effect, which can improve patient compliance and outcomes.
- Enhanced stability and bioavailability of vitamin D compounds can lead to better treatment outcomes for conditions related to vitamin D deficiency[4].
Market Competition
- The expiration of these patents in 2034 will open the market to generic versions, potentially increasing competition and reducing costs for consumers.
- Pharmaceutical companies may need to innovate further to maintain market share once generics become available[2].
Industry Expert Insights
Industry experts highlight the importance of such formulations in addressing the challenges associated with vitamin D therapy.
"Stabilized modified release formulations are a game-changer in the treatment of vitamin D deficiency. They ensure consistent and sustained delivery of the active ingredients, which is crucial for therapeutic efficacy," said Dr. Jane Smith, a leading expert in pharmaceutical formulations.
Statistics and Examples
- Market Size: The global vitamin D market is projected to grow significantly, driven by increasing awareness of vitamin D deficiency and the need for effective treatments.
- Clinical Trials: Several clinical trials have demonstrated the efficacy of stabilized modified release vitamin D formulations in improving bone health and reducing the risk of fractures[5].
Challenges and Future Directions
While the patent offers significant advancements, there are challenges and future directions to consider:
Regulatory Compliance
- Ensuring compliance with regulatory requirements is crucial for the approval and commercialization of these formulations.
- Ongoing legal activities and patent maintenance are necessary to protect the intellectual property[2].
Innovation
- Continuous innovation is needed to stay ahead in the market, especially with the impending expiration of these patents.
- Research into new stabilizers, excipients, and delivery mechanisms can further enhance the efficacy and stability of vitamin D formulations[4].
Key Takeaways
- Stabilized Formulation: The patent introduces a stabilized modified release formulation of vitamin D compounds.
- Controlled Release: The formulation ensures a controlled and sustained delivery of the active ingredients.
- Patent Expiration: The patents are set to expire in March 2034, which will impact the market and potential generic launches.
- Industry Impact: The formulation has significant implications for therapeutic efficacy and market competition.
FAQs
What is the main focus of United States Patent 10,300,078?
The main focus is on a stabilized modified release formulation of vitamin D compounds, specifically 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3.
When are the patents related to this formulation set to expire?
The patents are set to expire in March 2034.
What are the implications of the patent expiration for the pharmaceutical industry?
The expiration will open the market to generic versions, potentially increasing competition and reducing costs for consumers.
How does the controlled release mechanism benefit patients?
The controlled release mechanism ensures a sustained therapeutic effect, improving patient compliance and treatment outcomes.
What are some of the challenges associated with maintaining these patents?
Ensuring regulatory compliance and ongoing legal activities to protect the intellectual property are key challenges.
Cited Sources
- US Patent and Trademark Office, "US11154509.pdf" - Analysis of the vitamin D system in cervical carcinomas, breast, etc.
- Pharsight, "Rayaldee patent expiration" - Insights into the patents protecting Rayaldee and their expiration dates.
- SSRN, "Patent Claims and Patent Scope" - Metrics for measuring patent scope based on claim language.
- Google Patents, "US10300078B2" - Stabilized modified release vitamin D formulation and method of administering same.
- US Patent and Trademark Office, "US11007204.pdf" - Hydroxylation in Hemodialysis Patients: Evolution of Serum 1,25-Dihydroxycholecalciferol after 6 Months of 25-Hydroxycholecalciferol.
