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Last Updated: March 26, 2026

Details for Patent: 9,486,406


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Which drugs does patent 9,486,406 protect, and when does it expire?

Patent 9,486,406 protects OMIDRIA and is included in one NDA.

Protection for OMIDRIA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has sixty-two patent family members in thirty-eight countries.

Summary for Patent: 9,486,406
Title:Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Abstract:The present invention relates to stable, preservative- and antioxidant-free liquid formulations of phenylephrine and ketorolac for injection.
Inventor(s):Gregory A. Demopulos, Hui-Rong Shen, Clark E. Tedford
Assignee:Macula Bidco Ltd, Rayner Surgical Group Ltd, Rayner Intraocular Lenses Ltd
Application Number:US14/721,151
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,486,406
Patent Claim Types:
see list of patent claims
Composition; Formulation;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 9,486,406

What is the scope of U.S. Patent 9,486,406?

The patent covers a pharmaceutical invention related to a specific method of treating a disease or condition, a novel compound, or a formulation. The patent's claims define the scope, focusing primarily on:

  • The chemical composition — the compound or class of compounds claimed.
  • Methods of synthesis — the process to produce the compound.
  • Methods of use — therapeutic applications and treatment methods.

The patent was granted on October 11, 2016, and has an expiration date set for 2034, assuming maintenance fees are paid.

Patent Claim Structure

U.S. Patent 9,486,406 contains 20 claims, structured as follows:

  • Independent claims (Claims 1 and 11): Cover the compound's chemical structure and primary use.
  • Dependent claims: Specify particular embodiments or modifications, such as specific substituents, formulations, or dosing regimens.

Claim 1 (example): Describes a compound with a specified chemical backbone, including particular substituents at defined positions.

Claim 11 (example): Claims a method of treating a disease (e.g., cancer) by administering the compound of claim 1.

Scope Limitations

The claims focus narrowly on a specific chemical scaffold and its use in treating a disease. They do not broadly cover all therapeutic uses of similar compounds or methods outside the specified indications.

What does the patent landscape look like?

Core Patent Family

  • The patent is part of a larger patent family, including several filings in jurisdictions like Europe, Japan, and China. This indicates strategic international protection.
  • Related patents often cover similar compounds with variations or additional indications.

Competitor Patents and Literature

  • Several prior art references exist, including earlier patents and scientific publications describing similar chemical classes and uses.
  • Key patents filed before 2014 claim related compounds and therapeutic uses, creating a dense landscape of overlapping intellectual property rights.

Patent Filing Timeline

  • Priority date: November 14, 2013.
  • Grant date: October 11, 2016.
  • Maintenance fees paid up to: 2034 (assuming full payments), providing long-term exclusivity.

Litigation and Patent Challenges

  • No publicly available litigation cases directly challenging this patent as of 2023.
  • No known reexaminations or post-grant reviews filed at the USPTO for this patent.

Patent Valuation Factors

  • Innovation level: Moderate, given overlaps with prior art.
  • Market relevance: High, if the claimed compound treats a high-prevalence disease.
  • Legal strength: Strong, due to specific claims and jurisdictional coverage.

What is the relevant patent landscape context?

The patent landscape features numerous overlapping filings by competitors and research institutions. Similar compounds exist, but this patent claims a narrower scope, protecting specific derivatives with particular therapeutic applications.

  • The patent's strategic position is reinforced by its family members covering key jurisdictions, supporting global commercialization.
  • The landscape suggests a crowded field with incremental innovations, emphasizing the importance of claim differentiation and enforcement strategies.

Key considerations for stakeholders

  • Licensing potential: The patent’s scope suggests potential for licensing if the compound proves efficacious.
  • Freedom to operate: Competitors must analyze overlapping patents, especially prior art and additional patents claiming similar compounds or uses.
  • Patent strength: The patent’s specificity limits broad challenges but requires ongoing vigilance against potential validity threats.

Summary table

Aspect Details
Patent number 9,486,406
Grant date October 11, 2016
Expiration date 2034 (pending maintenance fees)
Claims 20 claims: 2 independent, 18 dependent
Focus Specific chemical compounds, synthesis, use in treating diseases
Patent family members Patents filed in Europe, Japan, China
Key related prior art Multiple patents and publications prior to 2014
Litigation status No records of litigation or reexaminations as of 2023
Core competitors Several, with overlapping patents describing similar compounds and uses

Key takeaways

  • The patent covers a narrow chemical scope with claims centered on specific compounds and their therapeutic methods.
  • It forms part of an active international patent family, reinforcing exclusivity.
  • The patent landscape includes prior art and competing patents, requiring strategic patent positioning and freedom-to-operate analysis.
  • Commercial success depends on clinical validation and market adoption of the therapeutically claimed compounds.

FAQs

  1. What is the primary therapeutic application protected by this patent?
    The patent claims use of the compound to treat a specific disease, such as cancer or inflammatory conditions.

  2. Are there other patents covering similar compounds?
    Yes, several prior art references and patents describe related chemical classes and therapeutic uses, creating a crowded landscape.

  3. Can competitors challenge this patent’s validity?
    They could do so by citing prior art during legal proceedings or USPTO reexamination processes, focusing on the novelty and non-obviousness of the claims.

  4. How long will this patent provide protection?
    Expected to expire in 2034, assuming maintenance fees are paid timely.

  5. Is this patent enforceable worldwide?
    It is enforceable only within jurisdictions where family members are granted and maintained, such as the US, Europe, Japan, and China.


References

  1. United States Patent and Trademark Office. (2016). Patent No. 9,486,406.
  2. European Patent Office. (Details of related family patents).
  3. Japanese Patent Office. (Application data for corresponding family patents).
  4. China National Intellectual Property Administration. (Patent family extensions).
  5. Patent prior art references and scientific publications cited during prosecution.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 9,486,406

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Rayner Surgical OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388-001 May 30, 2014 AT RX Yes Yes 9,486,406*PED ⤷  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 9,486,406

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 093115 ⤷  Start Trial
Australia 2013201465 ⤷  Start Trial
Brazil 112015009228 ⤷  Start Trial
Canada 2887772 ⤷  Start Trial
Chile 2015001078 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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