United States Patent 8,357,394: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,357,394, titled "Compositions and methods for improved efficacy of penicillin-type antibiotics," is a significant patent in the pharmaceutical industry, particularly in the realm of antibiotic formulations. This patent, owned by Pragma Pharmaceuticals LLC, addresses critical aspects of penicillin-type antibiotics, enhancing their efficacy and delivery.
Background and Prior Art
The patent builds upon existing knowledge in the field of antibiotic formulations, particularly focusing on penicillin-type antibiotics like amoxicillin. Prior art in this area includes various formulations and delivery methods aimed at improving the efficacy and bioavailability of these antibiotics[1][4].
Scope of the Patent
Compositions
The patent describes various compositions designed to enhance the efficacy of penicillin-type antibiotics. These include:
- Immediate Release Formulations: Designed to release the antibiotic quickly, ensuring rapid onset of action.
- Delayed Release Formulations: These can be pH-sensitive or non-pH sensitive, allowing for controlled release of the antibiotic at specific times or conditions.
- Sustained Release Formulations: Formulations that release the antibiotic over an extended period, maintaining therapeutic levels for a longer duration[1].
Methods
The patent outlines several methods for preparing these formulations, including:
- Coating Methods: Using coating agents to control the release of the antibiotic.
- Formulation Techniques: Involving the use of various excipients, polymers, and other materials to achieve the desired release profile[1].
Claims of the Patent
The patent includes several claims that define the scope of protection:
- Claim 1: A pharmaceutical composition comprising a penicillin-type antibiotic, a methacrylic acid copolymer, and a polyoxyl 35 castor oil, which provides improved efficacy.
- Claim 2: A method for preparing a sustained-release formulation of a penicillin-type antibiotic using a specific coating process.
- Claim 3: A dosage form comprising a delayed-release pellet coated with a pH-sensitive polymer[1].
Key Components and Materials
Polymers and Coating Agents
- Methacrylic Acid Copolymer: Used in sustained-release formulations to control the release of the antibiotic.
- Polyoxyl 35 Castor Oil: An emulsifying agent that enhances the bioavailability of the antibiotic.
- Triethyl Citrate: A plasticizer used in the coating process to improve the flexibility of the coating layer[1].
Excipients and Fillers
- Talc: Used as an anti-caking agent and filler.
- Granular Materials: Such as beads or pellets, which are coated with the antibiotic and other materials to achieve the desired release profile[1].
Patent Landscape and Exclusivity
Patent Expiration
The patent is set to expire on December 2026, along with other related patents protecting the same active ingredient. This expiration date is crucial for generic drug manufacturers, as it marks the time when they can legally produce generic versions of the drug[2].
Related Patents
Other patents, such as US8299052 and US8778924, also protect aspects of the same drug, including modified release formulations and methods for improved bacterial eradication. These patents collectively form a robust patent landscape that protects the intellectual property of Pragma Pharmaceuticals LLC until their respective expiration dates[2][4].
Impact on the Pharmaceutical Industry
Innovation and Competition
The patent encourages innovation in antibiotic formulations by providing a framework for improving the efficacy of penicillin-type antibiotics. However, it also limits competition by granting exclusivity to the patent holder until the patent expires[1].
Generic Launch
The expiration of this patent, along with others, will pave the way for generic versions of the drug. This is expected to increase competition and potentially reduce the cost of the medication, making it more accessible to a broader population[2].
Legal and Regulatory Considerations
Maintenance and Legal Activities
The patent's life can be affected by various legal activities such as maintenance fee payments, term extensions, or amendments to the claims. These activities are critical in determining the exact expiration date and the timing of generic launches[2].
International Protection
While the patent provides insights into exclusivity within the United States, it is also protected by patents in multiple countries. Understanding the global patent landscape is essential for strategizing market entry and identifying potential generic entry points[2].
Conclusion
United States Patent 8,357,394 is a pivotal patent in the field of penicillin-type antibiotics, offering significant improvements in efficacy and delivery. Its scope and claims provide a comprehensive framework for pharmaceutical companies to develop and market these antibiotics. As the patent approaches its expiration date, it will be crucial for both the patent holder and potential generic manufacturers to monitor the patent landscape closely.
Key Takeaways
- The patent covers various formulations and methods to improve the efficacy of penicillin-type antibiotics.
- Key components include methacrylic acid copolymer, polyoxyl 35 castor oil, and triethyl citrate.
- The patent is set to expire in December 2026, along with related patents.
- Expiration will allow for generic versions, increasing competition and potentially reducing costs.
- Understanding the global patent landscape is crucial for market strategy.
FAQs
What is the main focus of United States Patent 8,357,394?
The main focus of this patent is on compositions and methods to improve the efficacy of penicillin-type antibiotics, including immediate release, delayed release, and sustained release formulations.
What are the key components used in the formulations described in the patent?
The key components include methacrylic acid copolymer, polyoxyl 35 castor oil, and triethyl citrate, among others.
When is the patent set to expire?
The patent is set to expire in December 2026.
How does the patent impact the pharmaceutical industry?
The patent encourages innovation in antibiotic formulations but also limits competition by granting exclusivity to the patent holder until its expiration.
What happens after the patent expires?
After the patent expires, generic versions of the drug can be produced, potentially increasing competition and reducing costs.
Cited Sources:
- US8357394B2 - Compositions and methods for improved efficacy of penicillin-type antibiotics - Google Patents
- Moxatag patent expiration - Pharsight
- Patent Analytics - SLWIP
- US8299052B2 - Pharmaceutical compositions and methods for improved bacterial eradication - Google Patents
