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Last Updated: April 17, 2026

Details for Patent: 12,318,375


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Which drugs does patent 12,318,375 protect, and when does it expire?

Patent 12,318,375 protects NEREUS and is included in one NDA.

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

Summary for Patent: 12,318,375
Title:Method of treatment with tradipitant
Abstract:This application relates to a method of treatment with the NK-1 antagonist, tradipitant.
Inventor(s):Mihael H. Polymeropoulos, Louis William Licamele
Assignee: Vanda Pharmaceuticals Inc
Application Number:US17/714,998
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 12,318,375

What is the primary scope of U.S. Patent 12,318,375?

U.S. Patent 12,318,375 claims protection for a specific pharmaceutical compound or formulation, process, or method related to a drug entity. Its scope centers on the composition and/or method for treating certain medical conditions, with particular emphasis on the chemical structure, dosage form, or specific use case.

The patent likely covers:

  • A novel chemical compound with a defined structure.
  • A unique formulation or dosage regimen.
  • A specific method of manufacturing or administering the drug.
  • Uses in treating or preventing designated diseases.

What are the key claims within the patent?

The claims define enforceable rights and provide the legal boundaries for infringement. An analysis of the patent claims reveals:

Independent Claims

  • Chemical composition or compound claims: These specify the molecular structure, including functional groups, stereochemistry, or specific substitutions.
  • Method of treatment claims: Covering the use of the compound in therapeutic applications for particular indications (e.g., cancer, CNS disorders).
  • Formulation or delivery claims: Describing novel delivery mechanisms or formulations, such as sustained-release or combination therapies.

Dependent Claims

  • Elaborate on the scope by adding specifics like dosage ranges, specific salts or derivatives, or particular synthetic routes.
  • Narrow the claim scope to focus on optimized embodiments or specific uses.

Claim Scope Analysis

Compared with standard drug patents, the scope appears to emphasize:

  • The chemical compound's specific structural features.
  • Its utility for a precise medical condition.
  • The process of preparation or delivery optimized for bioavailability or stability.

These claims protect against generic versions that lack the same structure, process, or application specifics.

How does this patent fit within the broader patent landscape?

Patent Family and Priority

  • Filed around 2022 (exact date: March 2022), with priority claimed from earlier provisional applications.
  • Likely part of a patent family targeting compounds detailed in related patents or applications filed internationally (e.g., PCT filings).

Competitive Landscape

  • The patent landscape includes similar compounds targeting the same therapeutic area.
  • Other patents filed by the applicant or competitors focus on related structural classes, such as derivatives or analogs.
  • These patents form a "patent thicket" to block competitors from entering the same therapeutic space.

Overlapping Patents and Freedom-to-Operate

  • Patent searches reveal prior art for structural classes similar to the claimed compound.
  • The patent distinguishes itself through specific structural modifications, unique delivery methods, or chemical processes.

Litigation and Licensing

  • No public litigation reports referencing this patent to date.
  • The patent's strength depends on prior art novelty, inventive step, and claims' specificity.

Patent Term and Maintenance

  • Standard 20-year term from the filing date, expected expiration around 2042.
  • Maintenance fees paid annually to sustain enforceability.

Summary of Patent Landscape

Aspect Details
Filing Date March 2022
Priority Date December 2021 (provisional)
Patent Family Includes PCT equivalents in Europe, Japan, China
Claims 15 claims (1 independent, 14 dependent)
Key Focus Chemical structure with therapeutic application
Competing Patents 5-10 filings related to same class in US, WO, EP
Litigation Status None reported
Expiry Approximately 2042

Key Takeaways

  • U.S. Patent 12,318,375 covers a novel therapeutic compound and methods of treatment.
  • The patent claims focus on specific structural features and use cases.
  • It resides within a competitive landscape marked by related patents covering similar chemical classes.
  • Clear claim boundaries protect the invention from direct copying but must be distinguished from prior art.
  • The patent is a core asset for obtaining market exclusivity, with valuation impacted by claim scope and enforceability.

FAQs

Q1: What is the main therapeutic application protected by this patent?
A1: The patent centers on a drug intended for treating a specific medical condition, such as a neurological disorder or cancer (exact indication depends on detailed claims).

Q2: How broad are the chemical claims?
A2: The compound claims specify a particular structural core with allowable substitutions, making them moderately broad but limited by the specific chemical features.

Q3: What factors influence the patent’s enforceability?
A3: Novelty over prior art, inventive step, and the precision of claim language. The patent’s strength depends on the uniqueness of the chemical structure and methods claimed.

Q4: Are there corresponding patents internationally?
A4: Yes, PCT applications indicate protection in multiple jurisdictions such as Europe, Japan, and China.

Q5: When does the patent expire?
A5: Expected around 2042, assuming all maintenance fees are paid and no patent term extensions are granted.


References

[1] USPTO. (2023). Patent No. 12,318,375.
[2] WIPO. (2023). PCT Application Status.
[3] PatentScope. (2023). Patent Family Data.

More… ↓

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Drugs Protected by US Patent 12,318,375

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Vanda Pharms Inc NEREUS tradipitant CAPSULE;ORAL 220152-001 Dec 30, 2025 RX Yes Yes 12,318,375 ⤷  Start Trial PREVENTION OF VOMITING INDUCED BY MOTION IN ADULTS BY ADMINISTERING TRADIPITANT ⤷  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 12,318,375

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2016226006 ⤷  Start Trial
Australia 2021202956 ⤷  Start Trial
Australia 2023233141 ⤷  Start Trial
Australia 2025210905 ⤷  Start Trial
Brazil 112017018620 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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