Gamma-Hydroxybutyrate Compositions and Their Uses: A Detailed Analysis of U.S. Patent 10,195,168
Introduction
U.S. Patent 10,195,168, assigned to Jazz Pharmaceuticals Ireland Limited, is a significant patent in the field of pharmaceuticals, particularly focusing on gamma-hydroxybutyrate (GHB) compositions and their therapeutic applications. This patent is crucial for understanding the current landscape of GHB-based treatments, especially for sleep disorders.
Background on Gamma-Hydroxybutyrate (GHB)
GHB, also known as oxybate, is a central nervous system depressant that has been used for various medical conditions, including narcolepsy, cataplexy, and other sleep-related disorders. The patent in question delves into the formulation, production, and therapeutic uses of GHB compositions.
Patent Overview
Issuance and Assignee
- Patent Number: 10,195,168
- Issuance Date: February 5, 2019
- Inventors: Clark P. Allphin and Michael DesJardin
- Assignee: Jazz Pharmaceuticals Ireland Limited[5].
Patent Expiration
The patent is set to expire on January 11, 2033, which is a critical date for generic versions and potential competitors[5].
Scope of the Patent
Pharmaceutical Compositions
The patent describes pharmaceutical compositions and formulations that include mixed salts of gamma-hydroxybutyrate. These compositions are designed to enhance the stability, efficacy, and patient compliance of GHB treatments.
Methods of Preparation
The patent outlines various methods for making these pharmaceutical compositions and formulations. This includes the synthesis of mixed salts, such as sodium, potassium, and magnesium salts of GHB, which are crucial for the therapeutic effectiveness of the drug[4].
Therapeutic Uses
The patent covers a wide range of therapeutic uses for these GHB compositions, including:
- Narcolepsy: A neurological disorder characterized by excessive daytime sleepiness.
- Cataplexy: A condition that causes sudden muscle weakness.
- Sleep Apnea: A disorder that causes pauses in breathing during sleep.
- Sleep Time Disturbances: Including insomnia, nocturnal myoclonus, and other sleep-related issues.
- Sleep Paralysis: A condition that causes temporary paralysis when falling asleep or waking up.
- Hypnagogic Hallucinations: Hallucinations that occur when falling asleep or waking up.
- Sleep Arousal: Difficulty waking up from sleep[4].
Claims of the Patent
Composition Claims
The patent includes claims related to the specific compositions of GHB mixed salts, such as:
- Mixed Salt Formulations: Compositions that include a combination of sodium, potassium, and magnesium salts of GHB.
- Concentration and Dosage: Specific concentrations and dosages of these mixed salts for therapeutic use[4].
Method Claims
The patent also claims methods for administering these compositions, including:
- Administration Routes: Oral administration, which is the primary route for these compositions.
- Dosing Regimens: Specific dosing schedules to ensure efficacy and minimize side effects[4].
Use Claims
Claims related to the therapeutic uses of these compositions are a key part of the patent. These include the treatment of various sleep disorders and other conditions mentioned above.
Patent Landscape
Related Patents
The patent landscape for GHB compositions is complex, with multiple patents held by Jazz Pharmaceuticals that protect different aspects of GHB formulations and their uses. For example:
- U.S. Patent 8,591,922: Covers gamma-hydroxybutyrate compositions and their use for treating disorders.
- U.S. Patent 8,772,306: Another patent related to GHB compositions and their therapeutic applications[2].
Generic Availability
As of the current date, there is no therapeutically equivalent generic version of Xywav (the brand name for the GHB formulation covered by this patent) available in the United States. This is due to the ongoing patent protection and legal disputes over generic approvals[5].
Litigation and Infringement
Jazz Pharmaceuticals has been involved in several legal battles to protect its patents, including a notable case against Teva Pharmaceuticals over the submission of an Abbreviated New Drug Application (ANDA) for a generic version of Xywav. These legal actions highlight the importance of these patents in maintaining market exclusivity[2].
Patent Analytics and Claim Coverage
To fully understand the scope and claims of this patent, patent analytics tools can be invaluable. These tools help in:
- Claim Coverage Matrix: Identifying which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist[3].
- Scope Concepts: Categorizing patents by overarching scope concepts to link similar claims and analyze large numbers of patent claims efficiently[3].
Key Takeaways
- Patent Protection: U.S. Patent 10,195,168 provides comprehensive protection for GHB compositions and their therapeutic uses until January 11, 2033.
- Therapeutic Applications: The patent covers a broad range of sleep disorders and other conditions, making it a critical asset for Jazz Pharmaceuticals.
- Generic Challenges: The absence of a generic version of Xywav due to ongoing patent protection and legal disputes underscores the patent's significance.
- Patent Landscape: The complex patent landscape surrounding GHB compositions necessitates thorough patent analytics to understand claim coverage and potential gaps.
FAQs
What is the primary therapeutic use of the GHB compositions described in U.S. Patent 10,195,168?
The primary therapeutic use is for the treatment of sleep disorders, including narcolepsy, cataplexy, sleep apnea, and other related conditions.
Who is the assignee of U.S. Patent 10,195,168?
The assignee is Jazz Pharmaceuticals Ireland Limited.
When is the patent set to expire?
The patent is set to expire on January 11, 2033.
Are there any generic versions of Xywav available in the United States?
As of the current date, there are no therapeutically equivalent generic versions of Xywav available in the United States.
What tools can be used to analyze the scope and claims of this patent?
Patent analytics tools, such as Claim Coverage Matrix and scope concepts categorization, can be used to analyze the scope and claims of this patent efficiently.
Sources
- Google Patents - EP4081204A1 - Gamma-hydroxybutyrate (ghb) dosing.
- Insight.rpxcorp.com - Charles M. Lizza William C. Baton Sarah A. Sullivan One Riverfront.
- SLWIP - Patent Analytics | Intellectual Property Law.
- Google Patents - US10195168B2 - Gamma-hydroxybutyrate compositions and their uses for the treatment of disorders.
- Drugs.com - Generic Xywav Availability.
