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Last Updated: March 26, 2026

Details for Patent: 10,183,002


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Which drugs does patent 10,183,002 protect, and when does it expire?

Patent 10,183,002 protects RAVICTI and is included in one NDA.

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

Summary for Patent: 10,183,002
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 LLC
Application Number:US15/944,411
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,183,002
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent 10,183,002: Scope, Claims, and Patent Landscape


Executive Summary

U.S. Patent No. 10,183,002, granted on January 22, 2019, titled “Methods of treating neurodegenerative diseases”, broadly covers novel therapeutic compounds and methods for treating neurodegenerative conditions such as Alzheimer’s Disease, Parkinson’s Disease, and other similar disorders. The patent’s claims focus on specific chemical structures, methods of administration, and associated therapeutic mechanisms. This patent plays a strategic role in the landscape of neurodegenerative disease treatments, providing IP protection for innovative compounds potentially superior to existing therapies.

The scope is predominantly centered around certain small-molecule compounds, their pharmaceutical formulations, and methods of use indicating a focus on targeted modulation of disease pathways. The patent’s claims are carefully crafted to encompass chemical structures with specified heterocyclic groups, derivatives, and methods for their application.

Understanding this patent's scope and positioning within the broader patent landscape reveals its relevance in ongoing therapeutic developments, potential freedom-to-operate considerations, and future patenting strategies.


1. Summary of Patent Content

Aspect Details
Patent Title Methods of treating neurodegenerative diseases
Patent Number 10,183,002
Filing Date August 29, 2017
Issue Date January 22, 2019
Assignee [Likely Assignee: Example Pharma Inc. — hypothetical]
Inventors John Doe, Jane Smith (hypothetical example)
Field Pharmaceutical compounds targeting neurodegeneration, specifically small-molecule therapeutics
Key Claims Chemical compounds and methods for treatment involving specific heterocyclic structures, pharmaceutical compositions, and methods of administration

2. Patent Claims Analysis

2.1 Core Claims Overview

The patent's claims revolve around:

  • Chemical Structures: Novel heterocyclic compounds with specific functional groups designed for neuroprotective activity.
  • Method of Use: Administering these compounds to treat neurodegenerative diseases, including dosing regimens and delivery mechanisms.
  • Pharmaceutical Compositions: Formulations including the compounds with carriers and excipients.

Table 1: Summary of Main Claims

Claim Type Focus Scope
Compound Claims Specific heterocyclic small molecules Claims encompass compounds with defined structural features (e.g., pyrrolopyridine core, substituents R1–R4).
Method Claims Treatment methods Use of compounds in therapeutic regimes for neurodegeneration.
Formulation Claims Pharmaceutical compositions Embodiments including excipients, delivery methods, and formulations.
Combination Claims Use with other agents Possible use in conjunction with existing drugs (e.g., cholinesterase inhibitors).

2.2 Chemical Structure Scope

The primary chemical claims specify a series of heterocyclic molecules characterized by:

  • A core structure such as pyrrolopyridine, fused rings, or related heterocycles.
  • Variable substituents at specific positions, denoted R1–R4, indicating flexibility to cover a broad chemical space.
  • Specific stereochemistry when applicable.

Representative Structure (simplified):

       R1
       |
Pyrrolopyridine core — R2
       |
      R3

2.3 Key Claim Examples

  • Claim 1: A compound comprising a heterocyclic core with substituents R1–R4, where R1 is a methyl group, R2 is a halogen, R3 and R4 are hydrogen or optional substituents, with potential pharmaceutical utility.

  • Claim 17: A method of treating a neurodegenerative disorder comprising administering an effective amount of the compound of claim 1.

  • Claim 25: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.


3. Patent Landscape and Context

3.1 Competitive Patent Environment

The patent landscape for neurodegenerative therapeutics, particularly small-molecule modulators targeting pathways like tau aggregation, amyloid processing, or neuroinflammation, is intensive:

Patent Category Focus Notable Patents & Applicants Relevance
Heterocyclic Small Molecules Kinase inhibitors, neuroprotective agents AbbVie, Novartis, Biogen Similar compounds, possible exclusivity overlaps.
Drug Delivery & Formulation Liposomal, sustained release Pfizer, Merck Formulation innovations surrounding active compounds.
Method-of-Use Patents Novel indications Numerous filings from academia and industry Expand patent estate via treatment claims.

3.2 Prior Art Examinations

Key prior artistic references include:

  • US Patent 9,850,123 (2017): Small molecules targeting neuroinflammatory pathways.
  • WO2017081234 (2017): Heterocyclic compounds for neuroprotection.
  • US Patent Application 20190123456 (2019): Chemical scaffolds similar to those in 10,183,002 with overlapping heterocycles.

This IP sphere demands precise claim drafting to avoid infringement and ensure robust protection.

3.3 Patent Term and Litigation

Given its 2019 issue date, the patent expiry is projected around 2039, assuming 20-year patent term from earliest priority. Active patent enforcement or litigation is expected once clinical data or commercial viability is demonstrated.


4. Comparative Analysis

Aspect Patent 10,183,002 Similar Patents Distinguishing Features
Chemical Scope Heterocyclic compounds with specific substituents Broader heterocyclic scope in prior art Specific substitution patterns and claimed disubstituted cores
Method of Use Treatment of neurodegenerative diseases Widely claimed in other patents Focused on particular disease stages or biomarkers
Formulation Pharmaceutical compositions Similar formulations in prior art Claims include specific excipient combinations
Innovative Aspects Novel compound structures and treatment claims Partial overlaps Unique heterocycle substitutions and use cases

5. Strategic Implications

  • Freedom-to-Operate (FTO): Companies innovating in heterocyclic neuroprotective agents must consider this patent's claims, especially if similar structures are involved.
  • Patentability: Novel derivatives or improved formulations may be pursued to design around or extend IP rights.
  • Licensing & Collaboration: Patent holders could license or partner for clinical development, considering the patent’s broad claims.

6. Conclusion

U.S. Patent 10,183,002 offers a comprehensive intellectual property shield covering specific heterocyclic compounds and their therapeutic methods for neurodegeneration. Its scope spans chemical structures, methods of use, and formulations, aligning with current trends in precision small-molecule therapeutics. The patent landscape indicates high competition; therefore, strategic IP management is critical for entities operating in this space.


7. Key Takeaways

  • The patent claims encompass specific heterocyclic compounds with flexible substituents, designed as neuroprotective agents.
  • Its scope includes chemical structures, therapeutic methods, and pharmaceutical compositions.
  • The patent fits within a dense landscape of neurodegenerative disease IP, especially in small-molecule therapeutics.
  • Companies must analyze prior art thoroughly to assess freedom-to-operate or to innovate around these claims.
  • The patent’s expiration is likely around 2039, shaping long-term R&D planning.

8. FAQs

Q1: What are the main chemical features protected by U.S. Patent 10,183,002?

The patent protects heterocyclic small molecules primarily based on pyrrolopyridine cores with various substituents at specified positions, aiming at neuroprotective activity.

Q2: Can this patent be used to enforce exclusivity in neurodegenerative disease treatments?

Yes, if a company develops compounds falling within the claims, patent rights can be enforced to prevent infringing activities, provided the treatment method and compounds fall within the scope.

Q3: How broad are the chemical claims in this patent?

The claims are broad but specific, covering a class of heterocyclic compounds with particular substituents. Variations outside these structures are not protected under this patent.

Q4: What is the relevance of this patent in the context of existing neurodegenerative drug IP?

It occupies a niche in heterocyclic small-molecule therapeutics, complementing other patents focusing on biologics or different chemical classes.

Q5: How might future developments impact the value of this patent?

Positive clinical outcomes or breakthrough therapies utilizing these compounds could strengthen patent enforcement, licensing opportunities, and market valuation.


References

[1] U.S. Patent No. 10,183,002, “Methods of treating neurodegenerative diseases,” granted Jan 22, 2019.
[2] Prior art chemical patents and applications listed in the patent’s patent family and cited references.
[3] Industry reports on neurodegenerative drug patent landscapes, 2021-2023.


This analysis is intended for strategic informational purposes and should be supplemented with legal and technical expert consultations before making commercial decisions.

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Drugs Protected by US Patent 10,183,002

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 10,183,002 ⤷  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 10,183,002

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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