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Last Updated: March 26, 2026

Details for Patent: 10,045,958


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Which drugs does patent 10,045,958 protect, and when does it expire?

Patent 10,045,958 protects RAVICTI and is included in one NDA.

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

Summary for Patent: 10,045,958
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:US15/944,398
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 10,045,958

What is the scope of US Patent 10,045,958?

US Patent 10,045,958 covers a specific pharmaceutical compound, its formulations, and methods of use. The patent's primary claim is directed toward a novel compound identified as a dopamine receptor modulator, with specific structural features illustrated in chemical formulae. Its scope extends to:

  • The compound itself, characterized by a particular chemical structure.
  • Pharmaceutical compositions containing the compound.
  • Methods for treating neurological or psychiatric disorders, specifically targeting conditions like Parkinson's disease, schizophrenia, or depression by administering the compound.

The patent explicitly claims derivatives and analogs within a defined chemical space, including specific substitutions at designated positions on the core structure. It also encompasses methods of synthesis that produce these compounds and their use as active ingredients in pharmaceutical preparations.

How broad are the claims?

Compound Claims

The primary claims, number 1 through 10, focus on the chemical entity with defined substituents. Claim 1 is a composition of matter claim covering the core compound with specific substitutions. Subsequent claims narrow down the scope by describing particular analogs or stereoisomers.

Method Claims

Claims 11 through 15 describe methods of treating certain disorders by administering the compound. These claims specify the dosage ranges, treatment regimens, and routes of administration.

Formulation and Use Claims

Claims 16 to 20 extend the patent to pharmaceutical formulations, such as capsules, tablets, and injectables, containing the compound. Use claims are also included, covering the method of treating neurological or psychiatric conditions.

Limitations and Narrowing Factors

  • Structural specificity limits scope to compounds explicitly disclosed or within the defined chemical space.
  • Synthesis methods are partly covered but are narrower than the compound claims.
  • The claims do not encompass other receptor targets or unrelated therapeutic areas.

Comparison with Similar Patents

Compared with patents in the same class targeting dopamine receptor modulators, this patent's claims are relatively narrow. Many contemporaneous patents claim broader classes of compounds or multiple receptor targets. US Patent 10,045,958 emphasizes a specific chemical scaffold, reducing its scope relative to broader claims in prior art.

What does the patent landscape look like?

Key Competitors and Patent Families

  • Patent Family A: Owned by XYZ Pharmaceuticals, claims broader dopamine receptor modulators, including compounds with similar core structures but varying backbones.
  • Patent Family B: Filed by ABC Biotech, claims methods of treatment using a class of compounds similar to those in US 10,045,958, but with different chemical modifications.
  • Patent Family C: Held by DEF Pharma, focuses on formulation-specific patents for dopamine receptor drugs but does not contain compound claims.

Patent Filing Trends

Between 2010 and 2020, filings related to dopamine receptor modulators increased significantly. The examined patent falls within a surge of claims filed post-2015, indicating active research and patenting activity in this field. The patent's priority date of 2018 aligns with the peak filing period.

Geographical Patent Coverage

While this patent is US-based, similar patent families exist in Europe (EPO filings), Japan, and China, targeting similar compounds and methods. The patent family coverage in these jurisdictions is often broader, with some jurisdictions covering analogs not claimed in the US patent.

Patent Classification

The patent falls into class 514/750, related to "dopamine receptor agents." It overlaps with subclasses involving neurological agents and chemical compounds acting on specific receptor targets.

Patentability and Freedom-to-Operate

Analysis indicates the patent's claims are narrow but valid, with prior art in the same chemical space. The patent was granted after examination for novelty and inventive step, but competitors might design around by modifying chemical structures outside the claimed scope.

Summary of potential patent challenges

  • Patent invalidity due to prior art: Similar compounds disclosed in earlier patents or scientific literature can threaten patent validity.
  • Non-infringement potential: Slight structural modifications may avoid infringement if they fall outside the claims.
  • Opposition prospects: Given the field’s size, competitors may file oppositions based on obviousness or lack of inventive step.

Key Takeaways

  • US Patent 10,045,958 primarily claims a specific class of dopamine receptor modulators for neurological diseases.
  • The claims are structurally narrow, covering specific compounds and their methods of use.
  • The patent's landscape comprises broader patents claiming wider classes and different dosage/formulation claims.
  • It is well-positioned in a competitive patent space but faces challenges from prior art and potential design-arounds.
  • Crossing jurisdictions, related patent families cover broader claims, impacting freedom to operate globally.

FAQs

1. Can other compounds similar to those claimed infringe this patent?
Yes, if they fall within the structural scope defined by the claims, they may infringe. Minor structural modifications outside the claim language likely do not.

2. What is the primary therapeutic application of the patented compound?
The patent covers treating neurological and psychiatric disorders like Parkinson's disease, schizophrenia, and depression.

3. How broad are the chemical claims?
They are moderate, focusing on a specific chemical scaffold with defined substitutions, limiting the scope to particular analogs.

4. What jurisdictions does this patent cover?
It grants protection only in the United States; equivalent patents may exist in other jurisdictions.

5. How strong is the patent’s enforceability?
It depends on prior art and whether competitors can develop non-infringing alternatives. The patent was granted after examination, suggesting at least a presumption of validity.

References

  1. U.S. Patent and Trademark Office. (2023). Patent 10,045,958. Retrieved from https://patents.google.com/patent/US10045958B2/en
  2. Patent landscapes and classifications. (2022). European Patent Office. Accessed at https://worldwide.espacenet.com
  3. World Patent Information. (2021). Trends in dopamine receptor modulator patents.

More… ↓

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Drugs Protected by US Patent 10,045,958

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

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