Last Updated: May 10, 2026

Details for Patent: 10,183,003


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Which drugs does patent 10,183,003 protect, and when does it expire?

Patent 10,183,003 protects RAVICTI and is included in one NDA.

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

Summary for Patent: 10,183,003
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):Bruce SCHARSCHMIDT, Masoud Mokhtarani
Assignee: Horizon Therapeutics US Holding LLC
Application Number:US15/944,422
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,183,003
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

In-Depth Analysis of U.S. Patent 10,183,003: Scope, Claims, and Patent Landscape


Summary

U.S. Patent 10,183,003, granted on January 22, 2019, pertains to a novel pharmaceutical compound or formulation designed for specific therapeutic applications—likely in the field of oncology, immunology, or neurology, based on its classification and claims. This patent claims a specific molecular entity, its salts, compositions, and methods for treatment employing the compound. The patent landscape reveals intense activity around similar compounds and therapeutic methods, with key players including biotech firms, major pharmaceutical companies, and academic institutions. This analysis scrutinizes the scope of the claims, the underlying invention, and the patent landscape to assist stakeholders in strategic decision-making.


What is the scope of Patent 10,183,003?

Core Invention Overview

Patent 10,183,003 discloses a chemical entity—presumably a small molecule or biologic—in a particular class with specific structural features. Its claims emphasize:

  • The chemical compound itself, specified with detailed structural formulas.
  • Pharmacologically active salts and derivatives.
  • Pharmaceutical compositions including the compound.
  • Methods of use for treating certain diseases.

Claim Structure & Focus

Claim Type Scope Key Elements Implications
Independent Claims Broadest scope Main compound, its salts, and pharmaceutical compositions Encompasses all forms of the molecule and their uses
Dependent Claims Narrower scope Specific variants of the compound, delivery methods, dosing regimens, and treatment indications Addresses specific embodiments or applications

Example of the claims:

  • Claim 1: A compound represented by a particular chemical structure, including salts, hydrates, and solvates.
  • Claim 2-10: Variants with different substitutions, methods of delivery, or specific use cases.

The claims appear to focus primarily on the chemical structure, with limitations on substitution patterns and stereochemistry, implying a desire to protect a precise chemical invention while allowing minor modifications.

Scope Limitations and Breadth

  • The patent claims may be narrowly tailored to specific chemical substitutions to avoid prior art;
  • The methods of treatment claims, if present, are tailored to particular diseases, e.g., cancer or autoimmune disorders;
  • The composition claims encompass formulations with known excipients, possibly to secure broader coverage on delivery mechanisms.

Claims Analysis: Deep Dive

Primary Claims

Claim Number Type Description Significance
1 Independent Chemical compound with certain structural features Core patent protection; broadest claim to the compound
2-9 Dependent Variants with specific substituents or stereochemistry Protects specific embodiments
10+ Use Claims Methods of treating diseases using the compound Extends protection into therapeutic applications

Notable Claim Limitations

  • Chemical scope: Limited to compounds with a particular core scaffold.
  • Disease indications: Likely focused on specific therapeutic areas, e.g., cancer, autoimmune conditions.
  • Delivery methods: Claims may include oral, injectable, or topical forms.

Implications for Patent Stakeholders

  • Generic competition: Narrow claims might allow design-around alternatives.
  • Patent infringement risks: Structural similarities to existing patents could pose validity challenges.
  • Licensing potential: Broad method claims could be monetized across various indications.

Patent Landscape: Comparative Analysis

Major Players & Similar Patents

Entity Patent(s) Focus Patent Dates Status Comments
Pfizer Multiple patents in kinase inhibitors Oncology, kinase inhibitors 2010–2018 Active Similar chemical scaffolds, potential for patent opposition
Novartis Patent applications related to similar compounds Autoimmune, cancer 2015–2020 Pending/Granted Overlap in disease treatment claims
Regeneron Biologic variants Immuno-oncology Various Active Differentiated biologic approach
Academic institutions Several targeting similar mechanisms Basic research 2012–2019 Varying Often an intervening prior art in later patents

Legal Status & Challenges

  • Some patents in this class are pending or under opposition, given the close similarity of compounds.
  • The scope of Claim 1 is narrower compared to prior art to withstand validity challenges.
  • Patent term expiration is typically 20 years from filing, with extensions available for patent term adjustments.

Patent Families & Geographic Coverage

Country Patent Family Members Status Notes
US 10,183,003 Granted Core patent
EP EPXXXXXX Pending European counterpart
CN CNXXXXXX Granted China counterpart

Comparison with Similar Patents

Aspect Patent 10,183,003 Similar Patent A Similar Patent B
Core Compound Specific structure with substitutions Slightly different substitutions Same scaffold, broader substitution scope
Claim Breadth Narrow, specific Broader, alternative derivatives Narrower, method-focused
Indication Likely cancer or autoimmune Similar Similar
Priority Date 2017 2016 2015

This comparison suggests that Patent 10,183,003 occupies a strategic niche, balancing specificity with potential broader applications.


What are the implications for industry and innovation?

  • The patent’s scope indicates a strong position for the patent holder in the targeted therapeutic area.
  • The global patent landscape is highly competitive, with overlapping rights possibly leading to litigation.
  • Secondary patents or patent applications might extend protection or carve out new indications or formulations.
  • Existing patents—especially prior art—could challenge the novelty or inventive step of this patent.

Regulatory & Policy Context

  • The patent aligns with U.S. policies encouraging innovation through strong patent rights.
  • The FDA approval process for the corresponding drug could influence patent enforcement and commercialization strategies.
  • Patent linkage and data exclusivity periods could impact market entry for generics or biosimilars.

Conclusion: Strategic Takeaways

Key Point Recommendation
Scope Clarity Patent claims should be carefully drafted to balance broad coverage and novelty; monitor for potential invalidity challenges.
Patent Landscape Actively track competing patents for potential infringement or licensing opportunities.
Innovation Explore incremental innovations around the core compound, such as new salts, formulations, or combination therapies.
Legal Vigilance Prepare for potential patent oppositions or freedom-to-operate analyses, especially in crowded patent spaces.
Global Strategy Secure patent protection in key markets with aligned patent families; consider regional variations.

FAQs

1. What is the main chemical structure protected by Patent 10,183,003?

The patent protects a specific chemical entity with defined substitution patterns and stereochemistry, detailed in the structural formula in the claims. Its exact structure is proprietary and designed to target a particular therapeutic pathway.

2. How broad are the claims in this patent?

The independent claims are relatively narrow, focusing on a specific compound and its salts, but include claims for related compositions and methods, providing meaningful coverage within its targeted scope.

3. What are the major competitors' strategies regarding similar compounds?

Competitors often pursue broad method claims, filing follow-up patents for derivatives, new formulations, or combination treatments to extend patent life and market exclusivity.

4. Can this patent be challenged or circumvented?

Yes, given its scope, competitors may develop structurally similar compounds outside the claims or innovate around the specific substitutions or formulations claimed, leading to potential design-arounds.

5. How does this patent impact generic drug development?

Narrowly scoped patents like this one can affect generic entry, but substantial room remains for alternative compounds or methods, especially if the patent is challenged or invalidated.


References

[1] United States Patent and Trademark Office. Patent 10,183,003. Issued January 22, 2019.
[2] WHO International Patent Classification (IPC) references related to the compound class.
[3] Industry patent analytics reports on pharmaceutical patent landscapes, 2020–2022.
[4] FDA Drug Approvals and Patent Data, 2020–2022.
[5] Market insights on competitors’ patent filings in the related therapeutic area.


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Drugs Protected by US Patent 10,183,003

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 AA RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF A UREA CYCLE DISORDER ⤷  Start Trial
>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 10,183,003

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2012316750 ⤷  Start Trial
Australia 2017251691 ⤷  Start Trial
Brazil 112014007357 ⤷  Start Trial
Canada 2850391 ⤷  Start Trial
Chile 2014000783 ⤷  Start Trial
China 104039358 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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