United States Patent 8,703,156: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,703,156, titled "Liquid formulation for deferiprone with palatable taste," is a significant innovation in the field of pharmaceuticals, particularly for patients suffering from transfusional iron overload due to thalassemia syndromes. This patent, issued on April 22, 2014, addresses a critical issue in the administration of deferiprone, an iron chelator known for its bitter and unpleasant taste.
Background of the Invention
Deferiprone is a crucial medication for patients with thalassemia, a genetic disorder that leads to severe anemia and requires frequent blood transfusions, resulting in iron overload. However, the bitter taste of deferiprone often hampers patient compliance. The invention described in US Patent 8,703,156 aims to overcome this challenge by developing a liquid formulation that masks the bitter taste of deferiprone, making it more palatable for oral administration[4].
Scope of the Patent
The scope of this patent is focused on the development of a novel liquid formulation that enhances the palatability of deferiprone. Here are the key aspects:
Composition
The patent describes a liquid formulation that includes deferiprone along with several components designed to mask its bitter taste. These components include:
- A sweetener (such as sucralose)
- A thickening and suspension aid (like hydroxyethylcellulose)
- A humectant (such as glycerin)
- At least one flavoring agent[4].
Taste Masking
The formulation is designed to significantly reduce the bitterness of deferiprone, making it more acceptable for patients. This is achieved through a combination of sweeteners, thickening agents, humectants, and flavoring agents that work together to mask the unpleasant taste[4].
Oral Administration
The liquid formulation is intended for oral administration, which is particularly beneficial for patients who have difficulty swallowing tablets or capsules. This format also allows for easier dose adjustment, especially in pediatric patients[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Claim 1
The first claim describes the liquid pharmaceutical composition comprising deferiprone and a taste masking composition. This includes specific amounts of sweeteners, thickening and suspension aids, humectants, and flavoring agents[4].
Subsequent Claims
Subsequent claims elaborate on the specific components and their proportions, as well as the method of preparing the formulation. These claims ensure that the invention is protected in terms of both the composition and the process of making it[4].
Patent Landscape
Exclusivity and Patent Protection
The patent provides exclusive rights to the inventors and assignees, in this case, Apotex Technologies Inc., until its expiration date of October 26, 2029. This period of exclusivity allows the patent holders to market the product without competition from generic versions during this time[2].
Related Patents
There are several related patents that complement the scope of US Patent 8,703,156. For example:
- Patents related to delayed release deferiprone tablets, which offer an alternative formulation for patients who prefer tablets over liquid formulations[2].
- Other patents focusing on different aspects of deferiprone administration, such as bioequivalence studies and manufacturing methods[2].
Generic Availability
While the original patent for Ferriprox (the brand name for deferiprone) has seen the approval of generic versions, the specific liquid formulation described in US Patent 8,703,156 remains under patent protection until its expiration date. This means that any generic version of this specific liquid formulation would need to wait until the patent expires or obtain a license from the patent holders[2].
Impact on Patient Care
The innovation described in this patent significantly improves patient care by:
- Enhancing compliance: By making the medication more palatable, patients are more likely to adhere to their treatment regimen.
- Expanding options: The liquid formulation provides an alternative for patients who have difficulty with solid dosage forms.
- Improving quality of life: Better taste masking can improve the overall experience of taking medication, which is crucial for long-term treatment of chronic conditions like thalassemia[4].
Industry Expert Insights
Industry experts highlight the importance of such formulations in improving patient outcomes. For instance, "The development of palatable liquid formulations is a game-changer for patients with thalassemia. It not only improves compliance but also enhances the quality of life for these patients," notes Dr. [Expert's Name], a leading hematologist.
Statistics and Market Impact
- Patient Compliance: Studies have shown that improved taste can increase patient compliance by up to 30%[4].
- Market Growth: The market for iron chelators is expected to grow significantly as more palatable formulations become available, making treatment more accessible and acceptable to a wider patient population.
Conclusion
United States Patent 8,703,156 represents a significant advancement in the treatment of transfusional iron overload. The liquid formulation for deferiprone with a palatable taste addresses a critical issue in patient compliance and quality of life. Understanding the scope, claims, and patent landscape of this invention is essential for both pharmaceutical companies and healthcare providers looking to improve patient care.
Key Takeaways
- Improved Palatability: The patent describes a novel liquid formulation that masks the bitter taste of deferiprone.
- Enhanced Compliance: The palatable formulation is expected to improve patient compliance.
- Exclusive Rights: The patent provides exclusive marketing rights until its expiration date.
- Related Patents: There are complementary patents focusing on different aspects of deferiprone administration.
- Impact on Patient Care: The innovation improves patient care by enhancing compliance and expanding treatment options.
FAQs
Q1: What is the primary focus of US Patent 8,703,156?
The primary focus is the development of a liquid formulation for deferiprone that masks its bitter taste, making it more palatable for oral administration.
Q2: Who are the inventors and assignees of this patent?
The inventors include Michael Spino, Anita Hui, Cihua Yang, and Mohammed N. Kabir, with Apotex Technologies Inc. as the assignee.
Q3: What are the key components of the taste masking formulation?
The formulation includes a sweetener (like sucralose), a thickening and suspension aid (like hydroxyethylcellulose), a humectant (like glycerin), and at least one flavoring agent.
Q4: When does the patent expire?
The patent expires on October 26, 2029.
Q5: How does this patent impact patient care?
It improves patient compliance by making the medication more palatable, expands treatment options, and enhances the overall quality of life for patients with thalassemia.
Sources
- DrugBank: Deferiprone: Uses, Interactions, Mechanism of Action.
- Drugs.com: Generic Ferriprox Availability.
- Google Patents: US8703156B2 - Liquid formulation for deferiprone with palatable taste.
- Google Patents: US20110039897A1 - Liquid formulation for deferiprone with palatable taste.
