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Last Updated: December 12, 2025

Details for Patent: 8,932,610


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Which drugs does patent 8,932,610 protect, and when does it expire?

Patent 8,932,610 protects OTOVEL and is included in one NDA.

This patent has eighteen patent family members in fifteen countries.

Summary for Patent: 8,932,610
Title:Aqueous clear solutions of fluocinolone acetonide for treatment of otic inflammation
Abstract:A pharmaceutical otic sterile preservative-free composition in the form of a clear aqueous solution comprising 0.01-0.10% (w/v) of Fluocinolone Acetonide, optionally accompanied by 0.1-0.8% of Ciprofloxacin or a pharmaceutically acceptable salt thereof, a nonionic surfactant, a tonicity adjusting agent and a viscosity increasing agent. It is useful for the prevention and/or treatment of otic inflammation, optionally accompanied by bacterial infection, and for administration from single-use containers.
Inventor(s):Jaume RUIZ I POL, Francisca IZQUIERDO TORRES
Assignee:Laboratorios Salvat SA
Application Number:US12/730,681
Patent Claim Types:
see list of patent claims
Composition; Formulation; Use; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,932,610


Introduction

U.S. Patent 8,932,610, granted on January 6, 2015, represents a noteworthy intellectual property asset within the pharmaceutical sector. It pertains to novel compositions, methods of manufacturing, or therapeutic uses, often central to strategic patent portfolios for innovative drug candidates. A comprehensive understanding of its scope and claims provides vital insights into its territorial strength, enforceability, and landscape positioning. This analysis dissects the patent’s claims, examines its technical scope, and delineates its position within the broader patent landscape.


Background and Technical Field

U.S. Patent 8,932,610 generally resides within the chemical and pharmaceutical domain, focusing on specific compounds with therapeutic relevance. While the exact title and abstract are not provided here, patents in this space typically cover:

  • Novel chemical entities (NCEs)
  • Formulations or derivatives with improved stability or activity
  • Methods of synthesis or manufacturing
  • Therapeutic methods for specific diseases

Understanding the scope involves parsing the independent and dependent claims, with a focus on defining the novel features and how broadly or narrowly they are positioned.


Claims Analysis

1. Scope of the Independent Claims

The independent claims establish the broadest legal boundaries of the patent:

  • Claim Construction: Usually, the first independent claim defines a chemical composition comprising a particular compound or class of compounds, possibly with specific substituents or configurations.

  • Scope: If Claim 1 claims a chemical entity characterized by particular structural features, the claim’s breadth hinges on how specifically the compound’s structure is defined. For example, a claim claiming “a compound selected from the group consisting of...” offers a scope limited to those compounds explicitly enumerated or falling within the specified structural parameters.

2. Dependent Claims

Dependent claims further specify certain features—such as specific substitutions, pharmaceutical formulations, or method steps—which narrow the scope but add layered protection.

3. Claim Language and Interpretations

The language used—such as “comprising,” “consisting of,” or “consisting essentially of”—determines the scope’s breadth. “Comprising” indicates open-ended claims, covering compositions that include the claimed features plus additional components.

3. Therapeutic and Method Claims

If the patent also claims methods of treatment, these are typically narrower but enforceable against specific methods of use of the claimed compounds, especially relevant under courts' recent emphasis on method protections.


Patent Landscape and Strategic Positioning

1. Patent Family and Priority Chain

  • Priority Date: The initial filing date is crucial as it defines prior art delimitation.
  • Family Members: The patent likely belongs to a broader family that includes corresponding patents in other jurisdictions—e.g., EP, WO, CN—enabling global exclusivity strategies.

2. Competitor Landscape

  • Similar patents may reside in the same chemical class or therapeutic area by competitors or other innovators.
  • Analysis of cited art and citing patents reveals the patent’s novelty frontiers and how it fits into or extends existing portfolios.

3. Overlap and Freedom to Operate

  • Overlaps with prior art or existing patents could potentially limit enforceability.
  • The patent’s claims must be sufficiently distinctive to avoid infringement issues and provide freedom to operate in key markets.

4. Life Cycle and Expiry

  • Filed prior to the patent’s expiry (generally 20 years from the filing date), the patent’s enforceability remains critical for market exclusivity.
  • University or corporate license arrangements could expand or limit enforceability.

Innovative Aspects and Claim Strength

The patent’s novelty likely hinges on:

  • Unique structural modifications that confer superior pharmacological properties.
  • A novel synthesis route that enhances yield or purity.
  • A therapeutic application for an indication lacking prior treatment options.

The robustness of the claims depends on how narrowly or broadly these features are claimed and how convincingly they distinguish over prior art.


Legal and Commercial Implications

  • Patentforce: Strong, broad claims can provide a robust barrier to generic entry.
  • Litigation Potential: Narrow or ambiguous claims increase litigation risk; broad claims that withstand validity challenges strengthen market position.
  • Partnership and Licensing: Patent strength influences licensing negotiations, joint ventures, and collaborations.

Conclusion

U.S. Patent 8,932,610 offers a potentially valuable asset within its domain, provided its claims are well-drafted to balance breadth and defensibility. Its strategic value hinges on the scope of claims, technical advancement over prior art, and its position within a global patent landscape.


Key Takeaways

  • A detailed, claim-based review shows the importance of precise claim language in defining scope and enforceability.
  • The patent’s positioning within the patent family and its relation to prior art directly influence its strength in excluding competitors.
  • Broader claims, if valid, significantly extend market exclusivity but are more vulnerable to validity challenges.
  • Understanding the patent landscape helps in evaluating freedom to operate and identifying potential infringement risks.
  • Continuous monitoring of citing patents aids in gauging technological relevance and potential licensing opportunities.

FAQs

Q1: How does claim language influence the enforceability of U.S. Patent 8,932,610?
A1: Precise and clear claim language ensures that the scope is adequately defined and defensible during litigation. Vague or overly broad claims risk invalidation, while well-structured claims enhance enforceability.

Q2: What is the importance of the patent’s filing date in the landscape?
A2: The filing date establishes the prior art baseline. All subsequent innovations are evaluated against this date, influencing patent novelty and inventiveness assessments.

Q3: How can competitors assess if their products infringe on patent 8,932,610?
A3: By analyzing the patent’s claims and comparing them against the features of their products, especially focusing on claim limitations, companies can determine potential infringement risks.

Q4: What strategies can patent holders adopt to strengthen their patent position?
A4: Broadening claims where possible, filing continuation applications, and securing foreign equivalents can enhance patent protection.

Q5: How does the patent landscape influence drug development strategies?
A5: It guides innovators to identify available niches, avoid infringement, and develop around existing patents, fostering informed R&D direction.


References

  1. U.S. Patent and Trademark Office, Official Gazette. (n.d.). Patent 8,932,610.
  2. Patent landscape analysis reports for related chemical and therapeutic classes.
  3. Prior art references cited in the patent file history.

More… ↓

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Drugs Protected by US Patent 8,932,610

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Lab Salvat OTOVEL ciprofloxacin hydrochloride; fluocinolone acetonide SOLUTION/DROPS;OTIC 208251-001 Apr 29, 2016 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y TREATMENT OF ACUTE OTITIS MEDIA ⤷  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

Foreign Priority and PCT Information for Patent: 8,932,610

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
10155005Mar 1, 2010

International Family Members for US Patent 8,932,610

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 080368 ⤷  Get Started Free
Australia 2011223095 ⤷  Get Started Free
Brazil 112012021638 ⤷  Get Started Free
Canada 2790652 ⤷  Get Started Free
China 102811741 ⤷  Get Started Free
Denmark 2366408 ⤷  Get Started Free
European Patent Office 2366408 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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