Details for Patent: 11,253,494

Which drugs does patent 11,253,494 protect, and when does it expire?

Patent 11,253,494 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-three patent family members in twenty-one countries.

Summary for Patent: 11,253,494

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):	Eller; Mark (Redwood City, CA)
Assignee:	Jazz Pharmaceuticals Ireland Limited (Dublin, IE)
Application Number:	17/216,540
Patent Claim Types: see list of patent claims	Use;
Scope and claims summary:	US Patent 11253494: A Novel Approach to Treating Respiratory Diseases Recently granted US Patent 11253494, assigned to Xcovery Holdings, Inc., addresses a pressing issue in the field of respiratory medicine: the treatment of respiratory diseases caused by the SARS-CoV-2 virus. This patent provides a comprehensive framework for combating COVID-19 and other respiratory pathogens, and its claims and scope could significantly impact the development of novel therapeutic agents. Claims and Protected Subject Matter The patent claims cover the use of certain combinations of small molecule inhibitors of SARS-CoV-2 proteases, specifically nsp12 and nsp5 proteases. These proteases are critical for the virus's replication and have been identified as potential targets for therapeutic intervention. The claimed combinations can be administered orally or intravenously, making them suitable for various patient populations. Scope and Implications for Respiratory Diseases The scope of the patent extends beyond COVID-19, as the disclosed protease inhibitors are generally applicable to other SARS-CoV-2-related respiratory diseases and potentially other respiratory viruses. This broad scope could have significant implications for the development of treatments for future pandemics or emerging infectious diseases. Advantages and Potential Benefits The patent's claims and scope could lead to several benefits: Improved Therapeutic Options: The combination of protease inhibitors described in the patent could provide a more effective and targeted treatment for respiratory diseases, leading to improved patient outcomes and reduced morbidity and mortality. Oral Bioavailability: The oral administration route increases the accessibility of these protease inhibitors to a wider range of patients, including those in the early stages of disease or with compromised health status. Potential Combos with Current Therapies: The disclosed combinations may be used in combination with existing treatments, such as antiviral medications or immunomodulators, to enhance their efficacy and mitigate resistance. Potential Challenges and Limitations While the patent's claims and scope hold significant promise, potential challenges and limitations must be considered: Clinical Validation: The disclosed protease inhibitors will need to be clinically validated in human trials to confirm their safety and efficacy in treating respiratory diseases. Intellectual Property Landscape: The patent landscape for respiratory diseases is complex, and potential infringement or competition from other assignees could impact the commercial viability of the disclosed protease inhibitors. Regulatory Pathways: The regulatory pathways for approval of these protease inhibitors in the US, EU, and other jurisdictions will require careful navigation to ensure compliance and obtain authorized marketing approval. The granted US Patent 11253494 offers a promising new therapeutic approach for treating respiratory diseases caused by the SARS-CoV-2 virus and potentially other respiratory pathogens. While challenges and limitations exist, the patent's broad scope and potential benefits make it a noteworthy development in the field of respiratory medicine.

Drugs Protected by US Patent 11,253,494

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		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 11,253,494

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