Compositions Comprising Ephedrine or an Ephedrine Salt and Methods of Making and Using Same: A Detailed Analysis of US Patent 11,090,278
Overview of the Patent
The United States Patent 11,090,278, titled "Compositions comprising ephedrine or an ephedrine salt and methods of making and using same," was issued on August 17, 2021. This patent is assigned to Nexus Pharmaceuticals, Inc., with Ahmed Shahid as the inventor[2][4].
Patent Scope and Claims
Composition and Formulation
The patent describes compositions that include ephedrine or its salts, specifically ephedrine sulfate, which are formulated for immediate use in clinical settings. These compositions are designed to be stable and ready for administration, addressing the need for improved formulations of ephedrine sulfate[2][4].
Methods of Making
The patent outlines detailed methods for preparing these compositions. This includes the synthesis of ephedrine and its salts, as well as the processes for ensuring the stability and sterility of the final product. The methods involve various steps such as manufacturing processes, sterilization, and filtration to ensure the quality of the composition[4].
Methods of Using
The patent also covers the methods of using these compositions in clinical settings. Ephedrine and its salts are known for their use in treating conditions such as hypotension, and the patent provides guidance on the appropriate dosages and administration methods[2][4].
Key Components and Features
Active Ingredients
The primary active ingredient in these compositions is ephedrine or its salts, particularly ephedrine sulfate. The patent specifies the chemical structure and properties of these compounds[1][4].
Preservatives and Stabilizers
The compositions may include preservative agents to extend the shelf life and maintain the stability of the ephedrine sulfate. The patent lists various preservatives and stabilizers that can be used in the formulation[4].
Sterilization and Filtration
The patent emphasizes the importance of sterilization and filtration processes to ensure the product is free from contaminants and ready for clinical use. This includes heat treatment and other sterilization methods[4].
Patent Landscape
Related Patents
Several related patents have been issued to Nexus Pharmaceuticals, Inc., all of which pertain to compositions comprising ephedrine or its salts. These include patents 11,241,400, 11,464,752, 11,478,436, and 11,571,398, all with the same patent expiration date of May 16, 2040[2].
Patent Expiration and Exclusivity
The patent is set to expire on May 16, 2040, which is 20 years from the date of filing. Additionally, the patent holder may have exclusivity rights granted by the FDA, which can run concurrently with the patent term[2].
Legal and Regulatory Aspects
Patent Term and Adjustments
The patent term is subject to adjustments under 35 U.S.C. 154(b), although in this case, no adjustments have been made. The patent filing history includes provisional applications and international search reports, which are part of the patent prosecution process[4].
Prior Art and References
The patent cites several prior art documents, including U.S. patents and scientific publications, which are relevant to the formulation and use of ephedrine and its salts. These references help establish the novelty and non-obviousness of the claimed inventions[4].
Impact on the Pharmaceutical Industry
Innovation and Improvement
The patent represents an innovation in the formulation of ephedrine sulfate, providing compositions that are stable, sterile, and ready for immediate use. This can improve the efficiency and safety of clinical treatments involving ephedrine[2][4].
Competitive Landscape
The issuance of this patent and related patents gives Nexus Pharmaceuticals, Inc. a competitive edge in the market for ephedrine-based pharmaceutical products. The exclusive rights granted by the patent protect the company's investment in research and development[2].
Metrics for Patent Scope
Claim Length and Count
The scope of the patent can be measured by the length and count of the independent claims. Research suggests that narrower claims with shorter lengths and fewer counts are associated with a higher probability of grant and a shorter examination process[3].
Conclusion
The United States Patent 11,090,278 is a significant development in the pharmaceutical industry, particularly in the field of ephedrine-based treatments. The patent's detailed descriptions of compositions, methods of making, and methods of using ephedrine sulfate provide a comprehensive framework for clinical applications. The patent landscape indicates a strong position for Nexus Pharmaceuticals, Inc., in terms of intellectual property and market exclusivity.
Key Takeaways
- Composition and Formulation: The patent covers stable and sterile compositions of ephedrine or its salts, specifically ephedrine sulfate.
- Methods of Making: Detailed processes for synthesizing and formulating the compositions are provided.
- Methods of Using: Guidance on clinical use, including dosages and administration methods, is included.
- Patent Expiration: The patent is set to expire on May 16, 2040.
- Related Patents: Several related patents have been issued to Nexus Pharmaceuticals, Inc.
- Impact on Industry: The patent improves the efficiency and safety of ephedrine-based treatments and gives the patent holder a competitive edge.
FAQs
What is the primary active ingredient in the compositions described in US Patent 11,090,278?
The primary active ingredient is ephedrine or its salts, particularly ephedrine sulfate.
Who is the inventor and assignee of US Patent 11,090,278?
The inventor is Ahmed Shahid, and the assignee is Nexus Pharmaceuticals, Inc.
What is the expiration date of US Patent 11,090,278?
The patent is set to expire on May 16, 2040.
What are the key features of the compositions described in the patent?
The compositions are stable, sterile, and ready for immediate use in clinical settings, with preservatives and stabilizers to extend shelf life.
How does the patent impact the pharmaceutical industry?
The patent improves the efficiency and safety of ephedrine-based treatments and provides Nexus Pharmaceuticals, Inc. with a competitive edge in the market.
Sources
- US11090278B2 - Compositions comprising ephedrine or an ephedrine salt and methods of making and using same - Google Patents
- Generic Emerphed Availability - Drugs.com
- Patent Claims and Patent Scope - SSRN
- (12) United States Patent - Google APIs
- US20220257539A1 - Compositions comprising ephedrine or an ephedrine salt and methods of making and using same - Google Patents
