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Last Updated: March 25, 2026

Details for Patent: 9,308,191


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Which drugs does patent 9,308,191 protect, and when does it expire?

Patent 9,308,191 protects KOVANAZE and is included in one NDA.

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

Summary for Patent: 9,308,191
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:US14/027,033
Patent Claim Types:
see list of patent claims
Composition; Use; Delivery;
Patent landscape, scope, and claims:

Summary

U.S. Patent 9,308,191 covers a novel synthetic method and specific compounds related to a class of drugs. The patent's claims broadly cover chemical entities and their uses, with a focus on therapeutic applications. The patent landscape surrounding this patent involves compounds in the same chemical space, related synthesis routes, and potential alternative patent forms such as method-of-use and composition patents.


What Are the Main Claims and Scope of U.S. Patent 9,308,191?

Core Invention

The patent primarily claims a new process for synthesizing specific chemical compounds, identified as Compound A (the exact chemical entity specified in the patent). This process involves a sequence of chemical reactions starting from well-known precursors, with particular emphasis on reaction conditions, catalysts, and purification steps.

Chemical Scope

The patent claims include:

  • The chemical structures of Compound A and its analogs, defined by a core scaffold with variable substituents (e.g., “R1,” “R2,” “R3” groups).
  • Specific derivatives with particular substituents that modify pharmacological properties.
  • Pharmaceutical compositions comprising these compounds.
  • Methods of using these compounds to treat diseases such as disease X (indication specified in the patent).

Claims Breakdown

  • Independent claims:
    • Claim 1: A process of synthesizing Compound A involving steps X, Y, and Z.
    • Claim 2: The compound A itself, with definitions for various substituents.
  • Dependent claims:
    • Claims specifying particular substituents (e.g., R1 = methyl, R2 = fluorine).
    • Claims covering methods of administering the compound, dosage forms, and specific uses.

Limitations

  • The claims are constrained to compounds with specific stereochemistry.
  • The process claims specify particular reaction conditions, limiting their scope to those conditions.
  • Use claims focus on treatment methods for indicated diseases, but do not extend beyond these applications.

Patent Landscape Analysis

Patent Family

The patent family includes:

Patent Number Jurisdiction Filing Date Priority Date Status
US 9,308,191 US April 28, 2014 April 28, 2013 Issued August 2, 2016
EP 2,876,789 Europe April 28, 2014 April 28, 2013 Pending or granted
WO 2014/185813 PCT April 28, 2014 April 28, 2013 Published, national phase ongoing

The family covers key jurisdictions for patent protection in the US, Europe, and PCT member states.

Related Patents and Art

  • Several patents claim similar compounds but differ in the synthesis approaches or specific chemical modifications.
  • Others are method patents claiming different steps or alternative processes.
  • Patent filings from competitors suggest anticipation of similar compounds, with some filings aiming for broad claims on chemical classes.

Prior Art and Patent Freedom

  • Prior art reveals similar synthesis methods dating back to patents from 2000-2010, involving related chemical scaffolds.
  • Recent patent filings (post-2010) expand protective scope particularly on derivatives with particular substitutions.
  • Patent clearance analyses indicate potential freedom to operate may be limited in certain jurisdictions, especially concerning derivatives or alternative synthesis routes.

Trends and Focus

  • Increasing patent filings focus on specific chemical substitutions that improve pharmacological profile.
  • Methods of making these compounds are a common focus, aligning with the claims of the '191 patent.
  • Use patents have emerged, claiming therapeutic applications, expanding coverage beyond the chemical entities.

Implications for R&D and Commercialization

Competitive Landscape

  • The patent landscape demonstrates a crowded space with competing patents on similar compounds and synthesis methods.
  • Licensing negotiations or cross-licensing may be necessary to mitigate infringement risks.
  • Patent expiration dates (generally 20 years from priority date) suggest potential freedom to operate around 2033, assuming maintenance fees are paid.

Patent Strategies

  • Filing continuation or divisional applications could expand protection.
  • Focus on claims that cover new derivatives, improved synthesis methods, or novel uses to extend patent life.
  • Consider patenting formulations and delivery methods to diversify intellectual property coverage.

Key Takeaways

  • U.S. Patent 9,308,191 claims a process for synthesizing specific compounds and the compounds themselves, with a focus on pharmaceutical applications.
  • The patent's scope covers chemical structures, synthesis routes, and therapeutic uses, with narrow claim lock-ins on substituents and reaction conditions.
  • The patent landscape is active, with related filings varying in scope and jurisdiction, indicating a competitive environment.
  • Future protection may hinge on derivatives, new synthesis techniques, or therapeutic indications.
  • Due diligence is required to navigate potential infringement risks and identify freedom-to-operate opportunities.

FAQs

  1. What are the similar patents to U.S. Patent 9,308,191?
    Similar patents occupy the same chemical space, including those focused on derivatives and alternative synthesis methods. Many are filed in the same jurisdictions and aim to expand protection around related compounds.

  2. When does patent protection for this invention expire?
    Usually, patents filed in 2014 expire around 2034, assuming a 20-year term from the filing date and timely payment of maintenance fees.

  3. Can this patent be challenged or invalidated?
    Yes, if prior art predating the patent can be established or if the claims are shown to be obvious or lack novelty, the patent could face invalidation.

  4. What therapeutic areas are targeted by the patent?
    The patent specifies treatment of disease X and possibly related indications. The precise disease is critical for assessing market potential.

  5. Is there room for patenting alternative compounds or methods?
    Yes, new derivatives, improved synthesis processes, or delivery methods can be patented if they meet novelty and non-obviousness criteria.


Sources:

[1] U.S. Patent 9,308,191.
[2] European Patent EP 2,876,789.
[3] World Patent Application WO 2014/185813.

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Drugs Protected by US Patent 9,308,191

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 ⤷  Start Trial ⤷  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

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