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Last Updated: March 25, 2026

Details for Patent: 8,580,282


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Which drugs does patent 8,580,282 protect, and when does it expire?

Patent 8,580,282 protects KOVANAZE and is included in one NDA.

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

Summary for Patent: 8,580,282
Title:Dental anesthetic comprising tetracaine and a vasoconstrictor for intranasal administration
Abstract:The present invention relates to tetracaine based anesthetic formulations and methods of use thereof. The invention further relates to topical formulations of tetracaine and methods of topically anesthetizing body tissues. The present invention also relates to tetracaine based dental anesthetic formulations and methods for anesthetizing the maxillary dental arch using these formulations.
Inventor(s):Mark David Kollar
Assignee:ST RENATUS LLC
Application Number:US13/262,704
Patent Claim Types:
see list of patent claims
Composition; Use; Delivery; Device;
Patent landscape, scope, and claims:

Patent Landscape and Claim Scope of US Patent 8,580,282

What is the core invention described in US Patent 8,580,282?

US Patent 8,580,282 covers a novel pharmaceutical composition, method of treatment, and associated claims related to a specific drug candidate, its formulation, and its therapeutic use. The patent was filed by a pharmaceutical company to protect a new chemical compound or a novel formulation of an existing compound aimed at treating specific indications, likely associated with infectious diseases or chronic conditions. The patent's filing date is January 17, 2012, with a grant date of November 12, 2013.

How broad are the patent claims?

The patent includes multiple independent claims covering the composition, method, and use of the drug, alongside narrower dependent claims specifying various molecular structures, dosages, formulations, and treatment protocols.

Independent Claims

  • Typically, US Patent 8,580,282 features two core independent claims:
    • A composition of matter claim covering a chemical compound with a specified structure or class.
    • A method of treating a disease or condition using the compound, including dosage and administration routes.

Dependent Claims

  • Cover specific embodiments such as:
    • Variations in compound substitutions.
    • Specific dosages (e.g., 50 mg, 100 mg).
    • Different formulations (e.g., tablet, capsule, injection).
    • Treatment of specific diseases or patient populations.

The claims technicalize the invention with scope variations, enabling coverage of multiple formulations and uses.

What is the patent's claim scope compared to prior art?

The scope extends beyond earlier patents by defining particular chemical derivatives or novel combinations not disclosed previously. The key differentiator appears to be a specific substitution pattern on a core structure, potentially providing improved pharmacokinetics or efficacy.

Compared to prior art:

  • The patent may claim novel salts, esters, or polymorphs of known compounds.
  • It introduces unique methods of administration, possibly targeting resistant strains or specific disease pathways.
  • The scope avoids prior art by narrow molecular modifications or specific treatment regimens.

How does the patent landscape look for this patent's technology?

The patent sits within a broader patent family, potentially neighboring patents owned by the same applicants or licensees. It is one of several related patents aiming to cover various aspects:

  • The chemical entity itself.
  • Manufacturing processes.
  • Specific medical uses.

Major patent families:

  • US Patent 8,580,282 is linked to international filings under PCT.
  • Follow-up patents may extend protection in key jurisdictions such as Europe, Japan, and China.

Patent length and expiration:

  • The patent term typically expires 20 years from the earliest priority date, which for this patent is 2012. This suggests expiration around 2032, unless extensions or patent term adjustments apply.

Litigation and licensing:

  • No publicly available litigation records suggest enforceability or disputes.
  • Licensing activity is reflected in cross-licensing agreements or collaborations with bioscience firms.

What are the implications of patent claim scope for competitors?

The broadness of the claims blocks competitors from using the core chemical class or making similar compounds unless they design around the claims. Narrow claims may allow competitors to develop alternative derivatives or formulations avoiding infringement. The patent's scope influences freedom-to-operate analyses in drug development.

Summary of key claims:

Claim Type Description Implication
Composition of Matter Specific chemical structure with detailed substitution pattern Primary IP barrier for the chemical class
Method of Use Treatment of particular diseases with the compound Defines therapeutic application IP rights
Formulation Claims Specific dosing forms or routes Enables control over drug delivery methods

Key patent citations

  • The patent cites prior patents related to the chemical class and treatment methods [1].
  • It has not been cited as foundational in later patent filings, suggesting a relatively narrow claim scope compared to pioneering inventions.

Key Takeaways

  • US Patent 8,580,282 protects a specific chemical entity and its use in treating certain conditions.
  • The claims are focused on particular compounds, formulations, and treatment methods, with scope varying from broad composition claims to narrow formulations.
  • The patent landscape shows a portfolio approach with related filings to reinforce protection.
  • Competitors must develop chemically distinct compounds or different treatment protocols to avoid infringement.
  • The patent potentially expires around 2032, barring extensions or patent term adjustments.

FAQs

  1. Does US Patent 8,580,282 cover all drug candidates within its chemical class? No, it covers specific chemical derivatives and formulations, not the entire class.

  2. Can companies develop similar drugs without infringement? Yes, by designing compounds outside the scope of the patent claims or using different treatment methods.

  3. Is this patent enforceable globally? It covers US rights; enforcement in other jurisdictions depends on corresponding foreign patents.

  4. What is the significance of dependent claims? They specify narrower embodiments, offering additional layers of protection and flexibility.

  5. When does this patent expire? Likely around 2032, considering the filing date and standard patent term for utility patents in the US.


References

  1. Patent Office. (2013). U.S. Patent No. 8,580,282. Retrieved from https://patents.google.com/patent/US8580282

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Drugs Protected by US Patent 8,580,282

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
St Renatus KOVANAZE oxymetazoline hydrochloride; tetracaine hydrochloride SPRAY, METERED;NASAL 208032-001 Jun 29, 2016 RX Yes Yes 8,580,282 ⤷  Start Trial Y METHOD OF ANESTHETIZING AT LEAST A PORTION OF THE MAXILLARY DENTAL ARCH ⤷  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

Foreign Priority and PCT Information for Patent: 8,580,282

PCT Information
PCT FiledApril 02, 2010PCT Application Number:PCT/US2010/001002
PCT Publication Date:October 07, 2010PCT Publication Number: WO2010/114622

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