Avadel Pharmaceuticals has developed a patent for modified release formulations of gamma-hydroxybutyrate with enhanced dissolution and pharmacokinetic properties. The pharmaceutical composition includes immediate and delayed release particles containing sodium oxybate, binders, and specific coatings, along with suspending and acidifying agents for oral administration. GlobalData’s report on Avadel 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 Avadel Pharmaceuticals, was a key innovation area identified from patents. Avadel Pharmaceuticals's grant share as of April 2024 was 53%. Grant share is based on the ratio of number of grants to total number of patents.

Patent granted for modified release formulation of gamma-hydroxybutyrate

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

A recently granted patent (Publication Number: US11896572B2) discloses a pharmaceutical composition designed for oral administration, comprising immediate release particles and delayed release particles. The immediate release particles consist of a core of microcrystalline cellulose covered with a sodium oxybate loaded layer containing a binder made of povidone. These particles have a volume mean diameter ranging from 150 to 400 microns. On the other hand, the delayed release particles, triggered by pH, also have a core of microcrystalline cellulose with a sodium oxybate loaded layer containing povidone as a binder. These particles are further coated with a mixture of hydrogenated vegetable oil, methacrylic acid copolymer type C, and methacrylic acid copolymer type B, with specific weight ratios and coating percentages. The delayed release particles have a volume mean diameter between 200 to 800 microns. The composition also includes a suspending or viscosifying agent (a combination of xanthan gum, carrageenan, and hydroxyethylcellulose) and an acidifying agent (malic acid) in specific weight percentages.

Moreover, the patent claims that the pharmaceutical composition contains 3.0 to 12.0 g of sodium oxybate, with a specific ratio of sodium oxybate in the immediate release particles and delayed release particles ranging from 40/60 to 60/40. The composition is in powder form, intended to be suspended in water before oral administration. Importantly, the suspending or viscosifying agent and the acidifying agent are separate from the immediate release and delayed release particles, ensuring their distinct functionalities within the formulation. This innovative composition aims to provide a controlled release of sodium oxybate, a central nervous system depressant, for therapeutic purposes, potentially offering improved efficacy and patient compliance compared to existing formulations.

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

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