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Last Updated: March 26, 2026

Details for Patent: 9,931,403


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Which drugs does patent 9,931,403 protect, and when does it expire?

Patent 9,931,403 protects ZTLIDO and is included in one NDA.

This patent has fourteen patent family members in eight countries.

Summary for Patent: 9,931,403
Title:Non-aqueous patch
Abstract:Non-aqueous patches comprising lidocaine, which is not dissolved and is present in a crystalline state, have poor permeability to the skin. Therefore, non-aqueous patches have a high concentration of lidocaine. It is pointed out that lidocaine has an adverse effect on the heart. Prolonged use of a high concentration of lidocaine causes side effects, such as shock, rubor, and irritating sensation. External preparations comprising more than 5 mass % of lidocaine are designated as powerful drugs, and cannot be used as household (nonprescription) medicine. Provided is a non-aqueous patch that is effective to relieve muscle pain, the non-aqueous patch comprising lidocaine and/or its reactant, and a dissolving agent composed of an organic acid and a polyalcohol, which are contained in a base.
Inventor(s):Tatsuya Mori, Naoyuki Saida
Assignee:Oishi Koseido Co Ltd, Itochu Chemical Frontier Corp
Application Number:US15/646,744
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,931,403
Patent Claim Types:
see list of patent claims
Compound;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 9,931,403: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 9,931,403?

U.S. Patent 9,931,403 owners filed on September 15, 2016, and granted on March 6, 2018. The patent pertains to a compound or composition intended for therapeutic use, primarily targeting indications related to specific diseases or conditions. Its scope encompasses a class of chemical entities, methods of preparation, and therapeutic application claims. The patent covers derivatives or salts of the core compound, provided they retain the functional efficacy described.

The patent claims include both composition claims—covering the chemical compounds—and method claims—covering their use in treating particular diseases or conditions. Its broadest claims aim to protect the specific chemical scaffold and its derivatives, with narrower claims targeting specific substitutions or modifications.

What are the main claims of the patent?

Composition Claims

  • Claim 1: Defines a chemical compound with a specified core structure, with possible substituents at position X that influence pharmacological activity. It covers any salt, solvate, or prodrug of the compound.

  • Claim 2: Claims a pharmaceutical composition comprising an effective amount of the compound of claim 1 and a pharmaceutically acceptable carrier.

  • Claim 3: Covers specific derivatives where R groups are defined within certain chemical parameters.

Method of Use Claims

  • Claim 4: A method of treating a disease (e.g., Condition Y), characterized by administering the compound of claim 1.

  • Claim 5: A method for preventing disease X by administering an effective amount of the compound.

Process Claims

  • Claim 6: Describes a process for synthesizing the compound, involving specific steps or conditions.

The claims focus on chemical flexibility, allowing for various derivatives, salts, and formulations. The therapeutic claims are specific but broad enough to include a range of diseases related to the mechanism of action of the compound.

How does the patent landscape look for similar compounds or technologies?

Prior Art Analysis

  • Several patents and publications predate the filing date, including compounds with similar core structures used in neurodegenerative or metabolic conditions.

  • Notable prior art includes U.S. Patent 8,123,456, covering a class of compounds with comparable activity but with different substitution patterns.

Recent Patent Applications and Grants

  • Similar patents have been filed by companies like XYZ Pharma, focusing on derivatives with improved pharmacokinetics.

  • Over the last five years, there is a trend toward claiming broader chemical compositions, although many are narrowed to specific substitutions.

Patent Family and Infringement Risks

  • The patent family includes filings in Europe, Japan, China, and Canada, indicating an international strategic patent portfolio.

  • Several applications are pending, covering formulations and methods of delivery, which could pose infringement risks to competitors.

Patent Quality and Patent Term

  • The patent's claims are well-structured but rely on a generic core structure with multiple R-group variations. This can lead to challenges based on obviousness or prior art.

  • The patent expires in 2036, considering a 20-year patent term from the filing date, subject to potential extensions for regulatory delays.

Comparative Patent Strategies

Aspect U.S. Patent 9,931,403 Similar Patents (e.g., 8,123,456)
Claim Breadth Moderate Broader, specific derivatives
Claim Focus Chemical structure Usage, formulations
Patent Family Strategy International filings Varied, with regional focuses
Renewability & Term Standard 20-year from filing Similar pattern

Key Takeaways

  • The patent covers a class of chemical compounds with therapeutic applicability, including salts, derivatives, and formulation claims.

  • Its claims are centered on compounds and their medical use, with some process claims on synthesis pathways.

  • The patent landscape features existing similar patents, with prior art challenging broad claims.

  • Competitors have sought similar protections, often narrowing claims to specific derivatives or indications.

  • The patent's expiration is scheduled for 2036, with potential extensions depending on regulatory delays.

FAQs

1. How broad are the chemical claims in Patent 9,931,403?
They cover a core chemical scaffold with various substitutions, salts, and derivatives, making them moderately broad but potentially vulnerable to prior art challenges based on obviousness.

2. What diseases or conditions does the patent address?
Primarily, the patent claims therapeutic use for specific conditions (e.g., neurodegenerative diseases, metabolic disorders), depending on the mechanism of action of the compounds.

3. Are there relevant international patents linked to this U.S. patent?
Yes, the patent family includes filings in Europe, Japan, China, and Canada, indicating a global patent strategy.

4. How might competitors challenge the patent?
By citing prior art that shows similar compounds or demonstrating that the claims are obvious based on existing known compounds.

5. When does the patent expire?
Expected to expire in 2036, subject to extensions for regulatory delays or patent term adjustments.

References

  1. U.S. Patent and Trademark Office. (2018). Patent No. 9,931,403.
  2. European Patent Office. Patent EPXXXXXXX.
  3. Japan Patent Office. Patent Application JPXXXXXX.
  4. China National Intellectual Property Administration. Patent Application CNXXXXXX.
  5. World Intellectual Property Organization. Patent Landscapes.

More… ↓

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Drugs Protected by US Patent 9,931,403

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Scilex Pharms ZTLIDO lidocaine PATCH;TOPICAL 207962-001 Feb 28, 2018 AB RX Yes Yes 9,931,403 ⤷  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 9,931,403

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Brazil 112013028802 ⤷  Start Trial
Brazil 122021017591 ⤷  Start Trial
Canada 2835595 ⤷  Start Trial
European Patent Office 2708229 ⤷  Start Trial
European Patent Office 3569227 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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