United States Patent 10,722,510: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,722,510, titled "Liquid Naloxone Spray," is a significant patent in the pharmaceutical industry, particularly in the context of opioid overdose treatment. This patent, owned by Hikma Pharmaceuticals USA Inc., is part of a series of patents related to naloxone formulations. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Invention
Naloxone is a critical medication used to treat opioid overdose, opioid dependence, and other related conditions. The patent in question focuses on stable liquid formulations of naloxone, which are designed for intranasal or sublingual administration. This method of delivery is crucial for rapid action in emergency situations[1].
Scope of the Patent
The scope of the patent encompasses several key aspects:
Liquid Formulations
The patent describes liquid spray formulations containing an effective amount of naloxone, a pharmaceutically acceptable salt, or a derivative thereof. These formulations are characterized by their stability and the absence of isotonicity agents or buffers[1].
Composition
The formulations typically include water and a chelating agent. The water content can vary from about 10% to about 98% w/w, with specific preferred ranges such as 35% to 85% w/w. The presence of alcohol in some formulations is also noted, with water content ranging from about 40% to about 90% w/w[1].
Administration
The liquid spray formulations are designed for intranasal administration, which is a preferred method due to its rapid onset of action and ease of use in emergency situations. Sublingual administration is also mentioned as an alternative[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 typically describes the liquid spray formulation comprising naloxone, a pharmaceutically acceptable salt, or a derivative thereof, along with water and a chelating agent.
- Subsequent claims detail specific compositions, such as the percentage of water and the presence of alcohol[1].
Dependent Claims
- These claims further specify the formulation's characteristics, such as the concentration of naloxone, the type of chelating agent used, and the method of administration[1].
Patent Landscape
Related Patents
The patent 10,722,510 is part of a series of patents related to liquid naloxone sprays. Other patents in this series include US 11,135,155 B2, US 10,441,538 B2, and US 10,617,686 B2, all owned by Hikma Pharmaceuticals USA Inc. These patents collectively cover various aspects of naloxone formulations and their administration methods[1][5].
Litigation and Settlements
Patent litigation is a common aspect of the pharmaceutical industry. While the specific patent 10,722,510 is not mentioned in recent litigation updates, similar patents related to naloxone formulations have been involved in legal disputes. For example, Hikma Pharmaceuticals has been involved in lawsuits related to their Kloxxado® product, which is approved under an NDA that includes these patents[2][5].
Prior Art and Patent Scope
The scope of a patent is often a subject of debate, especially in terms of its breadth and validity. Studies have shown that narrower claims during the patent examination process are associated with a higher probability of grant and a shorter examination process. This is relevant as the claims in the 10,722,510 patent are specific and well-defined, indicating a thorough examination process[3].
Impact on the Pharmaceutical Industry
Market Significance
The liquid naloxone spray formulations covered by this patent are crucial in the treatment of opioid overdose, a significant public health issue. The ease of administration and rapid action of these formulations make them a valuable tool in emergency medicine.
Competitive Landscape
The pharmaceutical industry is highly competitive, especially in the generic drug market. Patents like 10,722,510 protect the intellectual property of companies like Hikma Pharmaceuticals, allowing them to maintain market exclusivity for their products. However, generic manufacturers often challenge these patents to enter the market, leading to litigation and settlements[2][4].
Key Takeaways
- Stable Liquid Formulations: The patent covers stable liquid naloxone formulations suitable for intranasal or sublingual administration.
- Specific Composition: The formulations include water, a chelating agent, and no isotonicity agents or buffers.
- Administration Methods: Intranasal administration is preferred due to its rapid onset of action.
- Patent Landscape: Part of a series of patents related to naloxone formulations, with potential for litigation and settlements.
- Market Impact: Crucial in treating opioid overdose, with significant market value and competitive implications.
FAQs
What is the primary use of the liquid naloxone spray formulations covered by this patent?
The primary use is for treating opioid overdose, opioid dependence, and congenital insensitivity to pain with anhidrosis through intranasal administration.
Who owns the United States Patent 10,722,510?
Hikma Pharmaceuticals USA Inc. owns the patent.
What are the key components of the liquid naloxone spray formulations?
The formulations include naloxone or its derivatives, water, and a chelating agent, without isotonicity agents or buffers.
How does the intranasal administration method benefit the treatment of opioid overdose?
Intranasal administration provides a rapid onset of action, which is critical in emergency situations involving opioid overdose.
Are there any related patents to 10,722,510?
Yes, there are several related patents owned by Hikma Pharmaceuticals USA Inc., including US 11,135,155 B2 and others, which cover various aspects of naloxone formulations.
Sources
- United States Patent and Trademark Office: US 11,135,155 B2 - Liquid Naloxone Spray.
- Robins Kaplan LLP: ANDA Litigation Settlements | Hatch-Waxman.
- SSRN: Patent Claims and Patent Scope.
- GreyB: Decoding latest drug patent infringement cases in pharma industry!
- RPX Corporation: In the United States District Court for the District of Delaware - Hikma Pharmaceuticals USA Inc. vs. Other Parties.
