Comprehensive Analysis of United States Patent 7,658,918: Stable Digestive Enzyme Compositions
Introduction
United States Patent 7,658,918, titled "Stable Digestive Enzyme Compositions," was granted to Eurand Pharmaceuticals Ltd. on February 9, 2010. This patent is crucial for the treatment and prevention of disorders associated with digestive enzyme deficiencies, particularly in conditions such as pancreatic insufficiency, pancreatitis, pancreatectomy, and cystic fibrosis.
Background of the Invention
The patent addresses the need for stable digestive enzyme compositions, especially pancreatic enzymes like pancrelipase, which are essential for patients with digestive enzyme deficiencies. Without these supplements, patients can suffer severe nutritional impairment, which can be life-threatening[1].
Key Claims and Embodiments
Composition and Stability
The patent describes several embodiments of stable digestive enzyme compositions. These compositions can include:
- Digestive Enzymes: At least one digestive enzyme, such as pancrelipase, which is stabilized to maintain its activity over time[1].
- Enteric Coating: The enzymes are coated with an enteric polymer and optionally an inorganic material to protect them from gastric acid and ensure release in the intestines[1].
- Moisture Content: The compositions have a moisture content of about 3% or less and a water activity of about 0.6 or less to enhance stability[1].
- Stability Testing: The compositions exhibit a loss of activity of no more than about 15% after six months of accelerated stability testing[1].
Dosage Forms
The patent includes various dosage forms such as:
- Tablets and Capsules: These are filled with the stable digestive enzyme compositions[1].
- Packaging: The dosage forms are packaged in sealed containers made of moisture-resistant material, often including a desiccant to maintain the stability of the enzymes[1].
Method of Preparation
The method of preparing these compositions involves coating particles of the digestive enzymes in an atmosphere with controlled moisture content, using a coating that includes an enteric polymer and an inorganic material[1].
Method of Treatment
The patent also covers methods for treating or preventing disorders associated with digestive enzyme deficiencies by administering these stable compositions to mammals in need thereof[1].
Patent Landscape and Exclusivities
Patent Expiry and Generic Launch
The patents related to stable digestive enzyme compositions, including US 7,658,918, are set to expire in February 2028. However, the generic launch of these drugs may be delayed due to FDA-granted exclusivities, which prevent other companies from marketing generic or bioequivalent versions of the drug until these exclusivities are no longer active[2].
Recent Legal Activities
The patent has undergone several legal activities, including the payment of maintenance fees and changes in power of attorney. These activities are crucial for maintaining the patent's validity and can affect its expiry date and the potential generic launch[2].
Competitive Landscape
The patent landscape for digestive enzyme compositions is highly competitive, with multiple patents focusing on different aspects of the active substances, such as dosage forms and modes of administration. Companies like Eurand Pharmaceuticals Ltd. have invested significantly in research and development to ensure the stability and efficacy of these compositions[2].
Impact on Patients and Healthcare
The stable digestive enzyme compositions described in this patent are vital for patients with conditions like cystic fibrosis. These compositions help in maintaining nutritional health by ensuring the enzymes remain active and are released in the appropriate part of the digestive system. The stability and efficacy of these compositions are critical for the long-term health and well-being of these patients[1].
Technological and Scientific Innovations
The development of these stable compositions involves advanced technological and scientific innovations, including the use of enteric coatings and controlled moisture environments. These innovations are essential for overcoming the challenges associated with maintaining the activity of digestive enzymes over time[1].
Economic and Market Implications
The expiry of these patents in 2028 could lead to the introduction of generic versions of the drugs, potentially reducing costs for patients and increasing market competition. However, the current exclusivities granted by the FDA will continue to protect the market dominance of the original drug until they expire[2].
Conclusion
United States Patent 7,658,918 represents a significant advancement in the treatment of digestive enzyme deficiencies. The stable digestive enzyme compositions described in this patent are crucial for maintaining the health and well-being of patients with conditions such as cystic fibrosis. Understanding the claims, embodiments, and the broader patent landscape is essential for both pharmaceutical companies and healthcare providers.
Key Takeaways
- Stable Compositions: The patent describes stable digestive enzyme compositions with enhanced stability and efficacy.
- Enteric Coating: The use of enteric coatings and inorganic materials to protect the enzymes from gastric acid.
- Dosage Forms: Various dosage forms such as tablets and capsules are included.
- Patent Expiry: The patents are set to expire in February 2028, but FDA exclusivities may delay generic launches.
- Impact on Patients: The compositions are vital for patients with digestive enzyme deficiencies, ensuring nutritional health.
Frequently Asked Questions (FAQs)
Q: What is the primary purpose of United States Patent 7,658,918?
A: The primary purpose is to describe stable digestive enzyme compositions for treating or preventing disorders associated with digestive enzyme deficiencies.
Q: What are the key components of the stable digestive enzyme compositions?
A: The compositions include at least one digestive enzyme, an enteric coating, and optionally an inorganic material, with controlled moisture content.
Q: When are the patents related to this invention set to expire?
A: The patents are set to expire in February 2028.
Q: How do FDA exclusivities affect the generic launch of these drugs?
A: FDA exclusivities prevent other companies from marketing generic or bioequivalent versions of the drug until these exclusivities are no longer active, potentially delaying the generic launch.
Q: What is the significance of the enteric coating in these compositions?
A: The enteric coating protects the digestive enzymes from gastric acid, ensuring they are released in the intestines where they are most effective.
Cited Sources
- United States Patent and Trademark Office, "Stable Digestive Enzyme Compositions," US 7,658,918 B1.
- Pharsight, "Zenpep patent expiration."
- IS Decisions, "Cybersecurity Innovations And The Patent Landscape."
- Justia Patents, "Method for dissolution testing of solid compositions."
- European Patent Office, "METHOD FOR DISSOLUTION TESTING OF SOLID COMPOSITIONS."
