United States Patent 10,973,814 B2: A Comprehensive Analysis
Introduction
The United States Patent 10,973,814 B2, titled "Liquid Naloxone Spray," is a significant patent in the field of pharmaceuticals, particularly in the treatment of opioid overdoses. This patent, assigned to Hikma Pharmaceuticals USA Inc., covers various aspects of liquid naloxone formulations and their applications.
Background and Context
Naloxone is a critical medication used to counteract the effects of opioid overdose. The development of liquid naloxone sprays has been a focal point in recent years due to their ease of administration and stability. This patent is part of a series of filings and continuations that reflect the ongoing innovation in this area[2].
Inventors and Assignees
The patent was invented by Kiran Amancha, Chandeshwari Chilampalli, Thrimoorthy Potta, Ningxin Yan, and Venkat R. Goskonda, all associated with Hikma Pharmaceuticals USA Inc. in various locations in Arizona[1].
Patent Details
- Patent Number: 10,973,814 B2
- Issue Date: April 13, 2021
- Provisional Application: Filed on July 8, 2014, as application No. 62/022,041
- Continuation-in-Part: This patent is a continuation-in-part of several earlier applications, including No. 16/674,424, filed on November 5, 2019[1].
Claims and Scope
The patent encompasses several key claims related to the formulation, composition, and method of administration of liquid naloxone sprays.
Formulation Claims
The patent describes stable liquid formulations containing naloxone or its pharmaceutically acceptable salts or derivatives. These formulations are designed to maintain the stability of naloxone, which is crucial for its efficacy in treating opioid overdoses[4].
Composition Claims
The claims specify the composition of the liquid naloxone spray, including the concentration of naloxone hydrochloride, and other excipients such as benzalkonium chloride, disodium edetate, and sodium chloride. The pH balance of the solution is also defined to ensure stability and effectiveness[3].
Method of Administration Claims
The patent includes claims related to the method of administering the liquid naloxone spray, which involves delivering the solution into a single nostril of a patient. This method is facilitated by specific devices, such as the Aptar UnitDose device[3].
Patent Landscape
The patent landscape for liquid naloxone sprays is complex and involves multiple patents and exclusivities.
Related Patents
Several patents related to liquid naloxone sprays have been issued to Hikma Pharmaceuticals USA Inc., including Patent 10,722,510 and Patent 11,135,155. These patents cover various aspects of the formulation, method of treatment, and devices used for the administration of naloxone[2].
Exclusivities
The FDA has granted exclusivities to certain naloxone products, including new product exclusivities that run concurrently with patent protections. For example, the exclusivity for Kloxxado, another naloxone product, expires on April 29, 2024[2].
Patent Expiration Dates
The patent 10,973,814 B2 is set to expire on August 26, 2034, assuming no extensions or adjustments under U.S. patent law[2].
Legal and Regulatory Considerations
Patent infringement and validity are critical issues in the pharmaceutical industry. The case of Adapt Pharma Operations Ltd. v. Teva Pharm. U.S., Inc. highlights the legal battles surrounding patented pharmaceutical formulations and methods of treatment. Such cases underscore the importance of patent protection and the need for companies to defend their intellectual property[3].
Industry Impact
The development and patenting of liquid naloxone sprays have significant implications for public health, particularly in the context of the opioid epidemic. These formulations provide a rapid and effective way to treat opioid overdoses, and their stability ensures they remain potent over time.
Conclusion
United States Patent 10,973,814 B2 is a pivotal patent in the field of opioid overdose treatment, covering critical aspects of liquid naloxone sprays. Understanding the scope, claims, and patent landscape of this invention is essential for pharmaceutical companies, healthcare providers, and regulatory bodies.
Key Takeaways
- Stable Formulations: The patent ensures the stability of liquid naloxone formulations.
- Specific Composition: The claims specify the exact composition of the spray, including concentrations of naloxone and excipients.
- Method of Administration: The patent includes claims related to the method of administering the spray.
- Patent Expiration: The patent is set to expire on August 26, 2034.
- Industry Impact: The development of these formulations is crucial in the fight against opioid overdoses.
Frequently Asked Questions (FAQs)
1. What is the primary use of the liquid naloxone spray covered by Patent 10,973,814 B2?
The primary use is to treat patients suffering from opioid overdoses by administering the spray nasally.
2. Who are the inventors of this patent?
The inventors are Kiran Amancha, Chandeshwari Chilampalli, Thrimoorthy Potta, Ningxin Yan, and Venkat R. Goskonda.
3. What is the significance of the pH balance in the liquid naloxone spray?
The pH balance, between 3.5 and 5.5, is crucial for maintaining the stability and effectiveness of the naloxone solution.
4. How does the patent protect the intellectual property of Hikma Pharmaceuticals USA Inc.?
The patent assigns exclusive legal rights to Hikma Pharmaceuticals USA Inc. to protect the proprietary chemical formulation, method of treatment, and devices used with the liquid naloxone spray.
5. Are there any related patents or exclusivities for similar naloxone products?
Yes, there are several related patents and exclusivities, including Patent 10,722,510 and Patent 11,135,155, and FDA-granted exclusivities for products like Kloxxado.
Cited Sources:
- United States Patent and Trademark Office. Liquid Naloxone Spray, US Patent 10,973,814 B2.
- Drugs.com. Generic Kloxxado Availability.
- Casetext. Adapt Pharma Operations Ltd. v. Teva Pharm. U.S., Inc.
- Google Patents. Liquid naloxone spray, US Patent Application 20190070105 A1.
