Hikma Pharmaceuticals has been granted a patent for stable liquid formulations containing naloxone for treating opioid overdose, dependence, and congenital insensitivity to pain with anhidrosis. The patent includes a nasal spray formulation with specific ingredients and concentrations for intranasal administration. GlobalData’s report on Hikma Pharmaceuticals gives a 360-degree view of the company including its patenting strategy. Buy the report here.

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According to GlobalData’s company profile on Hikma Pharmaceuticals, was a key innovation area identified from patents. Hikma Pharmaceuticals's grant share as of May 2024 was 30%. Grant share is based on the ratio of number of grants to total number of patents.

Nasal spray formulation containing naloxone for opioid treatment

Source: United States Patent and Trademark Office (USPTO). Credit: Hikma Pharmaceuticals Plc

A recently granted patent (Publication Number: US11975096B2) discloses a nasal spray formulation containing naloxone or its pharmaceutically acceptable salt, a chelating agent, ethanol, propylene glycol, and water. The formulation ranges from about 5% to 15% w/w of naloxone, with specific concentrations of ethanol (20% to 50% w/w) and propylene glycol (5% to 10% w/w). Additionally, a permeation enhancer such as benzalkonium chloride can be included in concentrations from 0.001% to 0.2% w/w. The pH of the formulation is maintained between 3 to 6, with naloxone typically at 8% w/w and water at 20% to 95% w/w.

Another aspect of the patent covers a nasal spray formulation with similar components but a slightly different composition. This formulation contains naloxone or its salt at 5% to 10% w/w, a chelating agent, a permeation enhancer (0.005% to 0.10% w/w), ethanol, propylene glycol, and water. The permeation enhancer concentration can range from 0.01% to 0.1% w/w, with edetate disodium dihydrate as the chelating agent and benzalkonium chloride as the preferred permeation enhancer at 0.01% w/w. The pH of this formulation is also maintained between 3 to 6, with naloxone typically at 8% w/w. pH adjustors can be added to ensure the pH falls within the desired range for optimal efficacy.

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GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies