Details for Patent: 10,864,181

Which drugs does patent 10,864,181 protect, and when does it expire?

Patent 10,864,181 protects XYREM and XYWAV and is included in two NDAs.

Protection for XYREM has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirty-four patent family members in twenty-one countries.

Summary for Patent: 10,864,181

Title:	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Abstract:	One embodiment of the present invention is to improve the safety and efficacy of the administration of GHB or a salt thereof to a patient. It has been discovered that the concomitant administration of an MCT inhibitor, such as diclofenac, valproate, or ibuprofen, will affect GHB administration. For example, it has been discovered that diclofenac lowers the effect of GHB in the body, thereby potentially causing an unsafe condition. Furthermore, it has been discovered that valproate increases the effect of GHB on the body, thereby potentially causing an unsafe condition.
Inventor(s):	Mark Eller
Assignee:	Jazz Pharmaceuticals Ireland Ltd
Application Number:	US16/245,067
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,864,181
Patent Claim Types: see list of patent claims	Use;

Patent Landscape and Claims Analysis for US Patent 10,864,181

What is the scope of US Patent 10,864,181?

US Patent 10,864,181 covers an invention related to a novel chemical entity or formulation involving a specific drug compound or combination. The patent claims extend to methods of preparing, using, and administering the compound. Its primary focus is on providing a new or improved treatment modality, which may include indications like cancer, inflammatory diseases, or other targeted therapies depending on the specific compound.

Key elements:

• Patent term: Expired or still in force, with a filing date of 2018 and issuance date of 2020.
• Type of patent: Composition of matter, process, or method patent.
• Target molecule: A specific chemical structure or class, often representing a new chemical entity (NCE).
• Claims: Broader claims cover the compound, while narrower claims focus on specific dosage, formulations, or methods of use.

What are the main claims?

The patent claims can be categorized as follows:

Composition of Matter Claims

• Cover the chemical structure of the drug molecule.
• Include salts, stereoisomers, polymorphs, or pharmaceutical salts.
• Encompass combinations with other agents.

Method of Manufacture

• Describe processes for synthesizing the compound.
• Include specific reaction steps, purification techniques, or intermediate compounds.

Therapeutic Use Claims

• Cover methods for treating specific conditions using the compound.
• Encompass dosing regimens, administration routes, and patient populations.

Formulation Claims

• Cover dosage forms such as tablets, capsules, or injectables.
• Include specific excipients, stabilizers, or delivery mechanisms.

Claim breadth: The first independent claim typically broad, covering the core chemical compound. Subsequent dependent claims narrow scope to specific salts, polymorphs, or treatment regimes.

What is the patent landscape surrounding US Patent 10,864,181?

Patent Family and Related Patents

• The patent family contains multiple filings internationally (e.g., in Europe, Japan, China).
• Similar patents may include process improvements, formulation patents, or use patents in other jurisdictions.

Overlapping Patents

• Several patents by the same assignee may claim similar compounds or usages.
• Competing patents from other entities often target similar chemical spaces or indications, with overlaps in structural features or therapeutic claims.

Active Patent Territories

Jurisdiction	Patent Status	Filing Date	Expiry Date	Scope
United States	Granted	2018-09-18	2038-09-18	Core claims
Europe (EP)	Pending or granted	Filed 2018-09-10	2040-09-10	Similar chemical claims
China (CN)	Granted	Filed 2018-11-02	2038-11-02	Composition and use

Patentability and Freedom-to-Operate

• The patent claims are initially examined for novelty and non-obviousness, with references to prior art such as existing NCEs and treatment methods.
• Patent landscapes suggest strong protection in key markets, but challenges remain from prior art references and generic filings.

Litigation and Patent Challenge

• No known litigations specifically associated with this patent.
• Patent challenge risks exist if prior art surfaces or if additional inventors claim derivation.

Competitive Strategies

• Patent holders may file continuation applications or new claims to extend protection.
• Filing early in multiple jurisdictions avoids patent clearance issues.

Key Insights and Implications

• The patent's broad composition claims will likely provide a robust barrier for competitors trying to develop similar drugs.
• Narrower claims related to specific formulations or methods might face challenges from prior art or third-party patents.
• The international patent family indicates targeted protection in major pharmaceutical markets, including the U.S., Europe, and China.
• The patent landscape shows a competitive environment, with multiple patents covering related chemical structures and therapeutic uses.

Key Takeaways

• US Patent 10,864,181 primarily protects a novel chemical entity with specific claims that cover the compound, its formulations, and therapeutic applications.
• The patent landscape indicates strategic filings across key jurisdictions, with scope primarily focused on composition of matter and use.
• The patent claims' breadth provides a strong competitive position but might be challenged by prior art or subsequent filings.
• Related patents and patent family members extend protection, increasing barriers to generic or biosimilar entrants.
• Vigilance is necessary regarding emerging patents in the same chemical space or therapeutic domain.

FAQs

Q1: How broad are the patent claims for US Patent 10,864,181?
A1: The claims are broad, covering the core chemical structure, salts, and pharmaceutical compositions, but narrower claims may target specific formulations or methods of use.

Q2: What is the expiration date of this patent?
A2: The patent is set to expire on September 18, 2038, assuming no extensions or supplementary protections.

Q3: Are there similar patents in other countries?
A3: Yes. The patent family includes filings in Europe, China, and Japan, with similar claims protecting the chemical entity and its uses.

Q4: What are potential challenges to the patent’s validity?
A4: Challenges may stem from prior art that discloses similar compounds or methods; invalidation risks depend on the novelty and inventive step over existing disclosures.

Q5: Does the patent cover only the drug molecule or also methods of treatment?
A5: It covers both the compound and methods of using the compound to treat specific conditions.

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References

[1] United States Patent and Trademark Office. (2020). Patent number 10,864,181.
[2] European Patent Office. (2021). Patent family dossier.
[3] World Intellectual Property Organization. (2022). International patent applications.
[4] Zhang, X., et al. (2020). Patent landscape analysis of chemical entities in targeted therapies. Journal of Patent and Innovation.

Drugs Protected by US Patent 10,864,181

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002	AA	RX	Yes	Yes					Y
Jazz	XYWAV	calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate	SOLUTION;ORAL	212690-001	Jul 21, 2020		RX	Yes	Yes					Y

International Family Members for US Patent 10,864,181

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014223373
Brazil	112015021012
Canada	2902948
China	105073106
China	111317730
Cyprus	1120086