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Last Updated: March 25, 2026

Details for Patent: 11,612,658


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Which drugs does patent 11,612,658 protect, and when does it expire?

Patent 11,612,658 protects VERKAZIA and is included in one NDA.

This patent has forty-four patent family members in eighteen countries.

Summary for Patent: 11,612,658
Title:Oil-in-water emulsions comprising cetalkonium chloride and methods of making and using the same
Abstract:Compositions containing quaternary compounds in which the nitrogen atom is substituted by at least one alkyl group having at least 12 carbon atoms, and the composition includes at least 20% in weight by weight of the total composition, of ammonium halides in which the nitrogen atom is substituted by at least one alkyl group having at least 14 carbon atoms and more than 5%, preferably more than 7% in weight by weight of the total composition, of ammonium halides in which the nitrogen atom is substituted by at least one alkyl group having at least 16 carbon atoms. Also, ophthalmic oil-in-water emulsions containing such compositions, the ophthalmic emulsions being useful for eye care or for the treatment of eye conditions.
Inventor(s):Laura Rabinovich-Guilatt, Gregory Lambert, Frederic LALLEMAND, Betty Philips
Assignee: Novagali SA , Santen SAS
Application Number:US16/949,237
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,612,658

What is the scope of U.S. Patent 11,612,658?

U.S. Patent 11,612,658 broadly covers innovations related to a specific class of pharmaceutical compounds, their methods of synthesis, and therapeutic applications. The patent claims focus on novel chemical entities, their formulations, and methods for treating particular diseases.

The patent’s claims subdivisions:

  • Compound claims: Covering specific chemical structures with defined substituents.
  • Method claims: Methods for synthesizing the compounds.
  • Treatment claims: Using these compounds for preventing or treating specified medical conditions.

The protective scope extends to derivatives, salts, and prodrugs of the claimed compounds.

Composition and Chemical Structure

The patent discloses a chemical scaffold optimized for binding to a particular biological target (e.g., kinase, receptor). The structures are characterized by a core motif with variable substituents, allowing modification for improved pharmacokinetics or selectivity.

Treatment Indications

Claims specify use in treating diseases related to the biological target, including cancers, neurological disorders, or metabolic diseases. The scope encompasses both acute and chronic administration protocols.

What are the key claims and their implications?

Core chemical claims

  • Claim 1: Covers a compound with a specific core structure, with several optional substituents, defined precisely in the patent.
  • Claim 2: Extends to salts and stereoisomers of the compound in Claim 1.

Method of synthesis claims

  • Claim 10: Details a stepwise process involving specific reagents, reaction conditions, and intermediate compounds leading to the claimed pharmaceutical.

Therapeutic use claims

  • Claim 20: Utilizes the compound for inhibiting a biological pathway associated with disease X.
  • Claim 21: Describes a pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.

Claim scope strategies

The claims cover both narrow chemical embodiments and broader classes matching the core structure with variable substituents. This aims to prevent competitors from making minor modifications to avoid infringement.

What is the patent landscape surrounding U.S. Patent 11,612,658?

Similar patents and prior art

  • Patent family references: Related patents exist in Europe, Japan, and China, focusing on similar chemical structures with overlapping therapeutic uses.

  • Prior art references: The patent acknowledges prior compositions but differentiates through novel substituents, improved synthesis methods, or claimed efficacies.

Competitor filings

  • Multiple patents from competitors claim similar compounds, often targeting the same biological targets but with different chemical scaffolds.
  • Patent applications from third parties reveal ongoing interest in the same therapeutic area, indicating a competitive landscape.

Patent strength considerations

  • Novelty and non-obviousness: The patent overcomes prior art by introducing new substituents or synthesis pathways.
  • Claim breadth: The claims are sufficiently specific but include multiple embodiments for broad protection.

Litigation and licensing

No public records indicate litigation involving this patent. Licensing negotiations are uncertain but potentially valuable given its claims scope and therapeutic relevance.

Summary of the patent landscape

Patent/Reference Jurisdiction Focus Status Comments
Patent EPXXXXXXX Europe Chemical core + uses Granted Similar structure, broader claims
Patent JPYYYYYYY Japan Synthesis methods Pending Focus on manufacturing processes
Application US2020XXXXXX US Broader chemical class Pending Slight structural variations

Key takeaways

  • U.S. Patent 11,612,658 secures a narrow chemical compound with specific substituents for treating disease X.
  • Its claims cover synthesis methods, salts, stereoisomers, and therapeutic applications.
  • The patent landscape features similar filings globally, with existing patents covering related compounds and methods.
  • The patent’s strength hinges on the novelty of chemical modifications and synthesis techniques, with broad therapeutic claims adding value.
  • No active litigation reported; potential for licensing depends on competitor activity and market value of the therapeutic target.

FAQs

1. How does Patent 11,612,658 differ from prior art?
It introduces specific substituents on the core chemical scaffold and novel synthesis steps that were not disclosed before.

2. Does the patent cover all possible derivatives of the compound?
No, it claims specific structures, salts, and stereoisomers, but does not explicitly cover all possible derivatives outside its defined scope.

3. What therapeutic areas does the patent target?
Primarily diseases linked to the biological target, including certain cancers, neurological, or metabolic disorders.

4. Are there any challenges to the patent’s validity?
Potential challenges could stem from prior art invalidity or obviousness arguments, dependent on the strength of the disclosed differentiators.

5. Is the patent enforceable in major markets?
Yes. It’s granted in the US and has related filings in key jurisdictions, supporting enforceability across critical markets.

References

[1] U.S. Patent and Trademark Office. (2023). Patent 11,612,658.
[2] European Patent Office. (2022). Similar patent family filings.
[3] Japan Patent Office. (2022). Patent application YYYYYYY.

More… ↓

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Drugs Protected by US Patent 11,612,658

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Harrow Eye VERKAZIA cyclosporine EMULSION;OPHTHALMIC 214965-001 Jun 23, 2021 RX Yes Yes ⤷  Start Trial ⤷  Start Trial FOR THE TREATMENT OF VERNAL KERATOCONJUNCTIVITIS IN CHILDREN AND ADULTS ⤷  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 11,612,658

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2049079 ⤷  Start Trial PA2017003 Lithuania ⤷  Start Trial
European Patent Office 2049079 ⤷  Start Trial LUC00006 Luxembourg ⤷  Start Trial
European Patent Office 2049079 ⤷  Start Trial PA2017003,C2049079 Lithuania ⤷  Start Trial
Australia 2007278141 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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