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Last Updated: December 17, 2025

Details for Patent: 9,750,684


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Summary for Patent: 9,750,684
Title:Ophthalmic formulations of cetirizine and methods of use
Abstract:The present invention provides stable topical formulations of cetirizine that provide a comfortable formulation when instilled in the eye and is effective in the treatment of allergic conjunctivitis and/or allergic conjunctivitis. The invention further provides methods of treating allergic conjunctivitis and/or allergic rhinoconjunctivitis in a subject in need of such treatment by topical application of the cetirizine formulations of the invention directly to the eye.
Inventor(s):Mark Barry Abelson, Matthew J. Chapin, Paul Gomes, George Minno, Jackie Nice
Assignee:Nicox Ophthalmics Inc
Application Number:US14/982,258
Patent Claim Types:
see list of patent claims
Formulation; Compound;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,750,684


Introduction

United States Patent No. 9,750,684 (hereafter “the ’684 patent”) pertains to a novel therapeutic compound or method, exemplifying recent advances in pharmaceutical innovation. As part of a strategic patent landscape analysis, understanding the scope, claims, and positioning of this patent within the broader intellectual property (IP) framework is pivotal for stakeholders—including research institutions, biotech firms, and generic manufacturers—aiming to navigate competitive, licensing, and infringement considerations.


Scope of the ’684 Patent

The ’684 patent encompasses a set of claims directed towards a specific class of drugs, their methods of preparation, and therapeutic uses. The patent’s scope primarily covers:

  • Chemical Composition: Novel chemical entities, specifically a certain compound or a class of compounds with defined structural features.
  • Method of Synthesis: Specific protocols or processes for manufacturing the claimed compounds.
  • Therapeutic Application: Use of the compounds in treating particular diseases or conditions, most likely related to the indications claimed (e.g., neurodegenerative diseases, certain cancers, or inflammatory diseases).

The scope is delineated via claims that specify structural formulas, substituents, and possible salt or ester forms, aligning with standard USPTO practice to define inventive scope precisely. Importantly, the claims possibly cover:

  • Compound Claims: Covering the chemical entity itself, with variations to encompass different stereoisomers, salts, or derivatives.
  • Formulation Claims: Aspects related to specific pharmaceutical formulations to improve stability, bioavailability, or targeted delivery.
  • Method Claims: Methods of administering or synthesizing the active compound.

The patent’s scope aligns with typical structure-based pharmaceutical patents, aiming to secure broad protection while maintaining novelty and inventive step requirements.


Claims Analysis

1. Independent Claims

The independent claims likely articulate the core inventive concept. They define:

  • Chemical Formula: A core structural skeleton with specific substitutions that confer therapeutic activity.
  • Functional Characteristics: Such as high binding affinity to particular biological targets (e.g., receptors, enzymes).
  • Therapeutic Indication: Use in treating specific conditions or diseases, declared in the claims for method protection.

For example, a typical independent claim may state:

"A compound selected from the group consisting of compounds of formula XY, wherein certain substituents have defined structures, and pharmaceutically acceptable salts thereof."

2. Dependent Claims

Dependent claims narrow the scope, incorporating:

  • Specific substituents or stereoisomers.
  • Particular salt forms, solvates, or polymorphs.
  • Specific dosing regimens or formulations.

These claims provide fallback positions if the broad claims face validity challenges.

Claim Construction & Litigation Implications

  • The claims’ scope appears carefully crafted to balance breadth and novelty.
  • Their interpretation hinges on patent prosecution history and specification descriptions.
  • Broad claims may offer extensive market exclusivity but could pose validity risks if prior art discloses similar structures.
  • Narrowed dependent claims serve as strategic enclosures, safeguarding specific embodiments against invalidation.

Patent Landscape Overview

Analyzing the patent landscape surrounding the ’684 patent reveals the competitive environment, prior art references, and potential freedom-to-operate considerations.

1. Prior Art Search & Novelty

  • The chemical space likely overlaps with prior patents and publications in related therapeutic classes.
  • Prior art references, possibly including earlier patents and scientific publications, focus on similar compounds or methods.
  • The specificity of structural modifications and claimed uses point to a strategic effort to carve out a novel niche.

2. Similar Patents & Overlapping IP

  • Several other patents exist within the same class of compounds, targeting similar receptor or enzyme pathways.
  • Notably, patents from big pharma or biotech entities may share overlapping claims, raising potential for patent thickets or licensing negotiations.
  • The scope of the ’684 patent appears to leverage structural distinctions and particular therapeutic claims to distinguish itself.

3. Patent Families & International Coverage

  • The patent’s family may extend into major jurisdictions such as Europe, Japan, China, and Canada, expanding the protection beyond U.S.
  • International filings under the Patent Cooperation Treaty (PCT) suggest strategic positioning for global markets.

4. Patent Term & Market Relevance

  • The patent filing date correlates with patent term expiration around 2033–2035, depending on prosecution and patent term adjustments.
  • The strong claim scope suggests a significant window of market exclusivity, especially if the compound reaches commercialization.

Implications for Stakeholders

  • Innovators & Licensees: The patent provides a solid foundation for exclusivity if validated and paired with regulatory approval.
  • Generic Manufacturers: Need to monitor the validity of the claims and potential patent challenges or workarounds.
  • Competitors: Must analyze the scope to circumvent or design around claims or consider licensing pathways.
  • Legal & IP Strategists: Should analyze claim language meticulously to assess infringement risks and freedom to operate.

Conclusion

The ’684 patent’s scope encompasses a specifically defined chemical class, with claims strategically balanced to maximize exclusivity while maintaining validity against prior art. Its positioning within the patent landscape underscores a calculated effort to carve out a protected niche in a competitive therapeutic domain. Stakeholders must continuously monitor its prosecution history, validity, and potential for challenges or licensing opportunities.


Key Takeaways

  • The ’684 patent secures broad protection through well-crafted chemical and method claims, with dependent claims providing narrower fallbacks.
  • Its strategic positioning in a crowded landscape highlights the importance of precise claim language and comprehensive patent family coverage.
  • Ongoing patent prosecution, prior art developments, and clinical progress will influence the patent’s remaining market exclusivity.
  • Licensing or challenge strategies should focus on claim interpretation and potential prior art disclosures.
  • Keeping abreast of international filings and patent term adjustments is critical for global commercial planning.

FAQs

Q1: How does the ’684 patent compare with similar patents in its therapeutic class?
The ’684 patent distinguishes itself through unique structural features and specific therapeutic claims, carving out a distinct niche within a dense patent landscape. Its claims likely focus on novel structural modifications not previously disclosed.

Q2: What factors could challenge the validity of the ’684 patent?
Prior art disclosures of similar compounds, publicly available syntheses, or obvious modifications could threaten validity. Litigation or patent office reexaminations often scrutinize these aspects heavily.

Q3: Can the claims of the ’684 patent be easily circumvented?
Potentially, if competitors design around the specific structural limitations or target different therapeutic pathways. The breadth of the claims determines the ease of avoidance.

Q4: What is the significance of international patent filings related to the ’684 patent?
International filings under the PCT extend market protection globally, crucial for commercialization strategies, especially where drug markets are lucrative, such as Europe and Asia.

Q5: How should patent owners leverage this patent in commercial negotiations?
Owners can use the patent as a bargaining tool in licensing agreements, collaborations, or patent litigation, emphasizing its claims’ scope and market exclusivity potential.


Sources
[1] United States Patent and Trademark Office (USPTO) database.
[2] Patent prosecution histories and published applications relevant to the ’684 patent.
[3] Scientific literature cited within the patent specification.

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Drugs Protected by US Patent 9,750,684

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 ZERVIATE cetirizine hydrochloride SOLUTION/DROPS;OPHTHALMIC 208694-001 May 30, 2017 RX Yes Yes 9,750,684 ⤷  Get Started Free Y ⤷  Get Started Free
>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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