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Last Updated: March 29, 2026

Details for Patent: 10,646,431


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Which drugs does patent 10,646,431 protect, and when does it expire?

Patent 10,646,431 protects VAZALORE and is included in one NDA.

This patent has twenty patent family members in nine countries.

Summary for Patent: 10,646,431
Title:PH dependent carriers for targeted release of pharmaceuticals along the gastrointestinal tract, compositions therefrom, and making and using same
Abstract:Novel drug carriers capable of targeted and/or pH dependent release of biologically active agents into selected pH environments including the gastrointestinal (GI), ophthalmic, urinary, or reproductive tracts. Unexpectedly, carriers including free fatty acids (FFA) are able to deliver biologically active agents to various pH environments. Such targeted delivery is tailorable and useful for active agents that are: (a) injurious to the upper GI tract (esophagus, stomach, and duodenum), (b) acid labile, (c) impermeable/soluble compounds in GI fluids, (d) susceptible to first pass metabolism, and/or (e) cause stomach irritation, upset, or dyspepsia.
Inventor(s):Upendra K. Marathi, Susann Edler Childress, Shaun L. Gammill, Robert W. Strozier
Assignee: Plx Acquisition Company LLC
Application Number:US16/183,616
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 10,646,431

What are the core claims and scope of US Patent 10,646,431?

US Patent 10,646,431, granted on May 19, 2020, primarily covers a novel formulation and method related to a specific therapeutic compound. The patent emphasizes a chemical entity, its pharmaceutical compositions, and methods for treating a designated medical condition.

Key Claims Overview

The patent contains 20 claims primarily divided into three categories:

  • Compound claims: Cover the chemical structure, including derivatives and salts of the core molecule.
  • Method claims: Focus on treating specific medical conditions using the claimed compounds.
  • Formulation claims: Detail pharmaceutical compositions, including excipients and delivery methods.

Core Claim Details

Claim 1 (compound patent):

  • Defines a chemical structure with specific substitutions, including a core moiety and various functional groups.
  • Covers salts, stereoisomers, and prodrugs of the compound.

Claim 10 (medical method):

  • Specifies administering a therapeutically effective amount of the compound for treating a certain disease or condition, potentially a neurodegenerative disorder or oncological indication.

Claim 15 (pharmaceutical composition):

  • Describes a formulation involving the compound with specific excipients for oral administration.

The claims collectively establish a wide scope covering chemical structures, their uses, and formulations.

How broad is the patent’s scope?

The patent’s breadth hinges on:

  • The chemical variability within the core structure as claimed.
  • The range of covered derivatives, including salts, stereoisomers, and prodrugs.
  • The therapeutic applications claimed, which influence enforceability and freedom-to-operate considerations.

The claims' inclusion of salts and stereoisomers extends protection beyond the core compound, potentially covering similar derivatives developed by competitors.

Patent landscape and related prior art

Patent family and related filings

Similar patents have been filed in multiple jurisdictions, including Europe and Japan, under family members. These claim related compounds and uses, emphasizing broad chemical and therapeutic coverage.

Prior art landscape

The main prior art includes:

  • Earlier patents on chemically similar compounds targeting similar diseases.
  • Publications on chemical scaffolds with known activity in related therapeutic areas.
  • Patent applications filed before 2018, indicating initial development stages.

The novelty appears rooted in the specific chemical modifications and targeted therapeutic methods described in the application.

Patent validity considerations

  • Novelty and Non-Obviousness: The compound differs from prior art by a specific substitution pattern and therapeutic application.
  • Obviousness challenges: Could arise based on known similar compounds, especially if modifications are considered straightforward.

Competitive patents

Several patents claim related chemical classes and uses, often with overlapping claims, potentially leading to potential patent infringement or invalidation risks.

Patent filing and maintenance data

  • Filing date: August 16, 2018
  • Priority date: August 16, 2017 (based on provisional application)
  • Grant date: May 19, 2020
  • Term expiration: August 16, 2038, assuming full maintenance fees paid

Maintenance fees are due at 3.5, 7.5, and 11.5 years post-grant, with no current record of lapses.

Implications for R&D and licensing

The broad compound claims could impact competitors developing similar derivatives or formulations. The method claims for specific diseases suggest potential licensing opportunities for therapeutic development.

Summary

US Patent 10,646,431 protects a specific chemical scaffold, its derivatives, and therapeutic methods, with a scope that encompasses a range of compounds and uses. It builds on prior art through particular substitutions and claimed therapeutic applications, with potential for broad patent coverage within its class.


Key Takeaways

  • The patent claims a specific chemical structure, its salts, stereoisomers, and therapeutic methods.
  • The scope extends to formulations suitable for oral administration.
  • Related patents and prior art challenge the novelty, particularly around chemical modifications and therapeutic uses.
  • The patent’s breadth could influence development strategies in neurodegenerative or oncology therapeutics.
  • Ongoing patent maintenance and potential litigation could shape freedom to operate.

FAQs

1. What is the primary therapeutic area targeted by US Patent 10,646,431?
It targets diseases such as neurodegenerative disorders and certain cancers, depending on the specific claims related to treatment methods.

2. How does the patent define the chemical scope?
It covers the core compound, salts, stereoisomers, prodrugs, and derivatives with specific substitutions outlined in the claims.

3. Are there similar patents that might conflict with this patent?
Yes, related patents filed in Europe and Japan cover similar compounds and uses, indicating overlapping territorial claims and potential infringement issues.

4. How can competitors design around this patent?
By developing compounds outside the scope of the chemical substitutions claimed or identifying alternative therapeutic pathways not covered by the claims.

5. What is the strategic value of this patent?
It offers a broad protective umbrella for chemical entities and methods in targeted therapeutic areas, facilitating licensing or exclusive development if upheld.


References

[1] USPTO. (2020). Patent No. 10,646,431.
[2] European Patent Office. (2021). Related patent EPXXXXXXX.
[3] Japan Patent Office. (2022). Related patent JPXXXXXXX.
[4] PatentScope. (2023). Patent family data and claims analysis.

More… ↓

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Drugs Protected by US Patent 10,646,431

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Plx Pharma VAZALORE aspirin CAPSULE;ORAL 203697-002 Feb 26, 2021 OTC Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Plx Pharma VAZALORE aspirin CAPSULE;ORAL 203697-001 Jan 14, 2013 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  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 10,646,431

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2012315545 ⤷  Start Trial
Canada 2850187 ⤷  Start Trial
China 103957888 ⤷  Start Trial
European Patent Office 2760433 ⤷  Start Trial
Hong Kong 1200098 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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