You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: June 14, 2025

Details for Patent: 10,045,959


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 10,045,959 protect, and when does it expire?

Patent 10,045,959 protects RAVICTI and is included in one NDA.

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

Summary for Patent: 10,045,959
Title:Methods of therapeutic monitoring of nitrogen scavenging drugs
Abstract: The present disclosure provides methods for evaluating daily ammonia exposure based on a single fasting ammonia blood level measurement, as well as methods that utilize this technique to adjust the dosage of a nitrogen scavenging drug, determine whether to administer a nitrogen scavenging drug, and treat nitrogen retention disorders.
Inventor(s): Scharschmidt; Bruce (San Francisco, CA), Mokhtarani; Masoud (Walnut Creek, CA)
Assignee: Horizon Therapeutics, LLC (Lake Forest, IL)
Application Number:15/944,416
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

United States Patent 10,045,959: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 10,045,959, titled "Methods of Therapeutic Monitoring of Nitrogen Scavenging Drugs," is a significant patent in the field of pharmaceuticals, particularly for the treatment of urea cycle disorders. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Background

The patent was issued on August 14, 2018, to Horizon Therapeutics U.S. Holding LLC, with Horizon Therapeutics USA, Inc. as the exclusive licensee. This patent is part of a series of patents related to methods of therapeutic monitoring and treatment using nitrogen scavenging drugs[2].

Scope of the Patent

Purpose and Application

The patent describes methods for therapeutic monitoring of nitrogen scavenging drugs, which are used to treat urea cycle disorders. These disorders result from deficiencies in enzymes that are crucial for the removal of ammonia from the body. The methods outlined in the patent involve monitoring and adjusting the dosage of these drugs to ensure effective treatment and minimize side effects[2].

Key Aspects

  • Monitoring Methods: The patent details specific methods for evaluating the efficacy and safety of nitrogen scavenging drugs. This includes measuring ammonia levels in the blood and adjusting the drug dosage accordingly.
  • Patient Treatment: The methods are designed to treat patients with urea cycle disorders, ensuring that the drug therapy is optimized for each patient's needs.
  • Clinical Significance: The patent highlights the importance of precise monitoring and adjustment of drug dosages to prevent complications associated with urea cycle disorders.

Claims of the Patent

Independent Claims

The patent includes several independent claims that define the scope of the invention. These claims typically describe the core methods and processes involved in the therapeutic monitoring of nitrogen scavenging drugs. For example:

  • Claim 1 might describe a method for monitoring ammonia levels in a patient's blood and adjusting the dosage of a nitrogen scavenging drug based on these levels.
  • Claim 2 could outline a specific protocol for measuring ammonia levels and the criteria for adjusting the drug dosage[2].

Dependent Claims

Dependent claims build upon the independent claims, providing additional details or specific embodiments of the invention. These claims may include:

  • Specific measurement techniques for ammonia levels.
  • Particular dosage adjustment protocols.
  • Additional monitoring parameters to ensure the efficacy and safety of the treatment[2].

Patent Landscape

Related Patents

The patent 10,045,959 is part of a larger family of patents held by Horizon Therapeutics related to nitrogen scavenging drugs. Other patents in this family include:

  • U.S. Patent Nos. 8,642,012, 9,254,278, 9,326,966, 9,561,197, 9,962,359, 9,999,608, 10,045,958, 10,183,002, 10,183,003, 10,183,004, 10,183,005, 10,183,006, and 10,668,040[2].

Global Patent Landscape

To understand the global implications, it is essential to search international patent databases. Resources such as the European Patent Office (EPO), Japan Patent Office (JPO), World Intellectual Property Organization (WIPO), and other national patent offices provide access to global patent collections. This helps in identifying similar or related patents filed in other jurisdictions[1].

Competitors and Litigation

The patent landscape also involves potential competitors and litigation. For instance, Horizon Therapeutics has been involved in patent infringement lawsuits against companies like Teva Pharmaceuticals, which sought to manufacture generic versions of Horizon's patented drugs[2].

Search and Analysis Tools

USPTO Resources

The United States Patent and Trademark Office (USPTO) provides several tools for searching and analyzing patents, including the Patent Public Search tool, Global Dossier, and the Common Citation Document (CCD) application. These tools help in identifying prior art, related applications, and citation data[1].

Derwent Innovations Index

Resources like the Derwent Innovations Index, accessible through Web of Science, offer comprehensive global patent search and analysis capabilities. This can be useful for identifying similar inventions and understanding the broader patent landscape[4].

Economic and Research Implications

Patent Claims Research Dataset

The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents and applications. This dataset can be used to analyze the scope and trends of patent claims, including those related to the therapeutic monitoring of nitrogen scavenging drugs[3].

Economic Impact

Patents like 10,045,959 have significant economic implications, particularly in the pharmaceutical industry. They protect intellectual property, allowing companies to invest in research and development while ensuring a return on their investments.

Key Takeaways

  • Scope and Claims: The patent 10,045,959 focuses on methods for therapeutic monitoring of nitrogen scavenging drugs, with detailed claims outlining the core processes and protocols.
  • Patent Landscape: The patent is part of a larger family of related patents and is subject to global patent searches and potential litigation.
  • Search and Analysis Tools: Various tools, including USPTO resources and the Derwent Innovations Index, are available for searching and analyzing patents.
  • Economic Implications: The patent has significant economic implications, protecting intellectual property and facilitating investment in pharmaceutical research.

FAQs

Q: What is the primary focus of United States Patent 10,045,959?

A: The primary focus is on methods for therapeutic monitoring of nitrogen scavenging drugs used to treat urea cycle disorders.

Q: Who is the assignee of the patent 10,045,959?

A: The assignee is Horizon Therapeutics U.S. Holding LLC, with Horizon Therapeutics USA, Inc. as the exclusive licensee.

Q: What tools can be used to search and analyze patents related to this invention?

A: Tools include the USPTO's Patent Public Search, Global Dossier, Common Citation Document (CCD), and resources like the Derwent Innovations Index.

Q: Why is it important to conduct global patent searches for this invention?

A: Conducting global patent searches helps in identifying similar or related patents filed in other jurisdictions, which is crucial for understanding the global patent landscape and potential competitors.

Q: What economic implications does this patent have?

A: The patent protects intellectual property, allowing companies to invest in research and development while ensuring a return on their investments, which has significant economic implications in the pharmaceutical industry.

Sources

  1. USPTO - Search for patents: https://www.uspto.gov/patents/search
  2. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE: https://insight.rpxcorp.com/litigation_documents/15640879
  3. USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
  4. Duke University Libraries - Finding Patents Online: https://guides.library.duke.edu/c.php?g=289276&p=1929213

More… ↓

⤷  Try for Free


Drugs Protected by US Patent 10,045,959

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Horizon Therap Us RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes 10,045,959 ⤷  Try for Free TREATMENT OF A UREA CYCLE DISORDER ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 10,045,959

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2012316750 ⤷  Try for Free
Australia 2017251691 ⤷  Try for Free
Brazil 112014007357 ⤷  Try for Free
Canada 2850391 ⤷  Try for Free
Chile 2014000783 ⤷  Try for Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.