Sodium Thiosulfate-Containing Pharmaceutical Compositions: A Detailed Analysis of U.S. Patent 10,479,686
Introduction
U.S. Patent 10,479,686, titled "Sodium Thiosulfate-Containing Pharmaceutical Compositions," is a significant patent in the pharmaceutical industry, particularly in the context of treating acute cyanide poisoning and other medical conditions. This patent, issued to Hope Medical Enterprises, Inc., encompasses various aspects of sodium thiosulfate, including its production, composition, and medical applications.
Background on Sodium Thiosulfate
Sodium thiosulfate is a sulfur donor used in medical treatments, most notably for the reversal of acute cyanide poisoning when used sequentially with sodium nitrite[1].
Patent Overview
Issuance and Assignee
The patent was issued on November 19, 2019, to Hope Medical Enterprises, Inc., with inventors Craig Sherman, Catherine Marie Smith, Kevin Robert Wirtz, and Erich Schulze[4][5].
Scope of the Patent
Pharmaceutical Compositions
The patent provides for pharmaceutically acceptable sodium thiosulfate and pharmaceutical compositions thereof. This includes formulations that are suitable for medical use, adhering to Good Manufacturing Practices (GMP) and meeting applicable quality specifications[4].
Methods of Production
The patent details methods for producing pharmaceutically acceptable sodium thiosulfate. This involves ensuring the purity and stability of the compound, which is crucial for its efficacy and safety in medical treatments[4].
Methods for Determining Total Non-Purgeable Organic Carbon
The patent also includes methods for determining the total non-purgeable organic carbon in a sodium thiosulfate-containing sample. This is important for quality control and ensuring the compound meets pharmaceutical standards[4].
Methods of Treatment
The patent covers methods of treatment that involve the administration of pharmaceutically acceptable sodium thiosulfate. This includes its use in treating acute cyanide poisoning and potentially other conditions where a sulfur donor is beneficial[4].
Claims of the Patent
Key Claims
The patent includes several key claims that define its scope:
- Claims related to the composition of sodium thiosulfate and its pharmaceutical formulations.
- Claims related to the methods of producing sodium thiosulfate that meet pharmaceutical standards.
- Claims related to the methods for determining the purity and quality of sodium thiosulfate.
- Claims related to the methods of treatment using sodium thiosulfate[4].
Classification
The patent is classified under various categories, including A61K 31/519, A61K 31/573, A61K 31/60, and others, indicating its relevance to pharmaceutical compositions and medical treatments[4].
Patent Landscape
Related Patents
The patent is part of a series of patents related to sodium thiosulfate-containing pharmaceutical compositions held by Hope Medical Enterprises, Inc. Other relevant patents include U.S. Patent Nos. 8,496,973, 9,345,724, 9,585,912, and 11,753,301, which collectively protect various aspects of sodium thiosulfate production, composition, and use[2][5].
Patent Expiration Dates
The patent is set to expire on July 7, 2030, which is a critical date for generic manufacturers and competitors who may seek to enter the market with similar products after the patent expires[5].
Litigation and Enforcement
Hope Medical Enterprises, Inc. has been involved in litigation to protect its patents, including actions against generic manufacturers who have submitted Abbreviated New Drug Applications (ANDAs) to the FDA. These actions aim to prevent infringement and ensure the exclusivity of Hope's products until the patents expire[2].
Impact on the Pharmaceutical Industry
Innovation and Competition
The patent landscape around sodium thiosulfate-containing pharmaceutical compositions influences innovation and competition in the pharmaceutical industry. The patents held by Hope Medical Enterprises, Inc. provide a monopoly on the production and sale of these compositions until the patents expire, which can affect the development of generic alternatives and the overall market dynamics[3].
Quality and Safety
The methods and standards outlined in the patent ensure that sodium thiosulfate products meet high quality and safety standards, which is crucial for patient safety and the efficacy of the treatment[4].
Conclusion
U.S. Patent 10,479,686 is a comprehensive patent that covers various critical aspects of sodium thiosulfate-containing pharmaceutical compositions. It protects the production, composition, and medical use of these compositions, ensuring high standards of quality and safety. The patent's expiration date and the broader patent landscape around sodium thiosulfate will significantly impact the pharmaceutical industry, particularly in terms of innovation, competition, and patient access to these life-saving treatments.
Key Takeaways
- Patent Scope: Covers pharmaceutical compositions, production methods, quality control methods, and treatment methods involving sodium thiosulfate.
- Issuance and Assignee: Issued to Hope Medical Enterprises, Inc. on November 19, 2019.
- Expiration Date: Set to expire on July 7, 2030.
- Impact on Industry: Influences innovation, competition, and quality standards in the pharmaceutical industry.
- Litigation: Hope Medical Enterprises, Inc. has been involved in litigation to protect its patents against generic manufacturers.
FAQs
What is the primary use of sodium thiosulfate in medical treatments?
Sodium thiosulfate is primarily used as a sulfur donor for the reversal of acute cyanide poisoning, often in combination with sodium nitrite[1].
Who is the assignee of U.S. Patent 10,479,686?
The assignee of U.S. Patent 10,479,686 is Hope Medical Enterprises, Inc.[4][5].
What are the key claims of U.S. Patent 10,479,686?
The key claims include those related to the composition, production, quality control, and treatment methods involving sodium thiosulfate[4].
When is the patent set to expire?
The patent is set to expire on July 7, 2030[5].
Why is the patent landscape around sodium thiosulfate important?
The patent landscape affects innovation, competition, and the availability of generic alternatives in the pharmaceutical industry, which in turn impacts patient access to these treatments[3].
Sources
- DrugBank: Thiosulfuric acid: Uses, Interactions, Mechanism of Action.
- RPX Corporation: Case 1:22-cv-00978-RGA-JLH Document 62 Filed 09/14/23.
- Hoover Institution: Patent Claims and Patent Scope.
- Google Patents: United States Patent 10,479,686.
- Drugs.com: Generic Nithiodote Availability.
