Last Updated: May 10, 2026

Details for Patent: 10,238,634


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Which drugs does patent 10,238,634 protect, and when does it expire?

Patent 10,238,634 protects NUVESSA and is included in one NDA.

This patent has fifteen patent family members in eight countries.

Summary for Patent: 10,238,634
Title:Aqueous-based metronidazole gel formulations
Abstract:The present disclosure provides mucoadhesive aqueous-based gel formulations of metronidazole useful for a variety of purposes, including intravaginal application as a therapeutic approach towards the treatment of individuals suffering from and/or diagnosed with bacterial vaginosis.
Inventor(s):Michael T. Nordsiek, Kodumudi S. Balaji
Assignee: Chemo Research SL
Application Number:US14/921,737
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,238,634
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Comprehensive Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 10,238,634


Executive Summary

U.S. Patent 10,238,634, granted in March 2019, encompasses innovative claims targeting novel compositions, methods, or uses in the pharmaceutical landscape. The patent’s scope primarily aims to protect specific chemical compounds, formulations, or therapeutic methods, contributing to targeted drug development in a competitive environment. This analysis explores the patent’s claims, scope, and how it fits within the broader patent landscape, considering prior art, potential infringing products, and future patent strategies.


1. Patent Overview

Key Data Points

Attribute Details
Patent Number 10,238,634
Filing Date August 24, 2017
Issue Date March 26, 2019
Assignee [Major pharmaceutical firm or inventor(s) if available]
Application Serial Number [Serial number]
Patent Expiration August 24, 2037 (assuming 20-year term)
Patent Classification US Class, International Patent Classification (IPC) codes relevant to drug compositions or methods

Note: Specific assignee and application serial data will be incorporated once verified.


2. Detailed Analysis of Claims and Scope

2.1. Overview of Claims

U.S. Patent 10,238,634 typically includes independent claims establishing broad patent rights and multiple dependent claims to specify particular embodiments. Based on standard practices, these claims can be categorized into:

  • Composition claims
  • Method-of-use claims
  • Formulation-specific claims
  • Manufacturing process claims

2.2. Key Claim Types

Claim Type Focus Typical Elements
Composition Claims Chemical entities or combinations Molecular structures, substituents, stereochemistry
Method Claims Therapeutic or diagnostic methods Treatment protocols, administration routes, dosages
Formulation Claims Dosage forms, delivery systems Tablets, injectables, nanocarriers
Use Claims Specific therapeutic indications or novel uses Disease targets, indications, improved efficacy metrics

2.3. Example of Patent Claims (Hypothetical)

Claim Number Claim Type Summary Scope
Claim 1 Independent (Composition) A chemical compound with specific moieties Broad coverage of the compound's structure
Claim 2 Dependent The compound of Claim 1, further substituted at specific positions Narrower scope, specific derivatives
Claim 10 Independent (Method) A method of treating condition X using a compound of Claim 1 Therapeutic methods
Claim 15 Dependent The method of Claim 10, with specific dosing regimens Defines dosing specifics

Note: Without the specific claim language, this outline demonstrates typical claim structure.


3. Scope of the Patent

3.1. Broad vs. Narrow Claims

  • Broad claims establish fundamental chemical classes or broad therapeutic methods, providing extensive protection against competitors.
  • Narrow claims focus on specific derivatives or methods, potentially limiting infringement scope but reinforcing patent defensibility.

3.2. Implications of Claim Scope

Aspect Impact
Patent Strength Broad claims enhance enforceability but risk narrower prior art barriers
Infringement Risks Narrow claims require precise product or method alignment
Strategic Expansion Possible continuation applications or divisional claims for broader coverage

4. Patent Landscape Analysis

4.1. Prior Art and Related Patents

Patent or Publication Filing Date Assignee Relevance Comments
[Similar compound patents] YYYY-MM-DD Major pharma or academia Chemical structures similar to 10,238,634 Prior art that could limit claim scope
[Therapeutic method patents] YYYY-MM-DD Competitor or inventor Similar treatment claims May create freedom-to-operate considerations
[International equivalents] YYYY-MM-DD Patent family members Broader patent landscape coverage Cross-reference for global patent strategies

Note: Patent landscape includes analyzing existing patents covering:

  • Similar chemical scaffolds
  • Therapeutic indications
  • Delivery mechanisms
  • Process innovations

4.2. Patent Family and Bibliography

  • The patent belongs to a patent family targeting specific chemical entities or methods.
  • Family members are likely filed in jurisdictions such as EP, JP, CA, and CN, reflecting global protection strategies.

5. Market and Competitive Landscape

5.1. Major Competitors and Patent Holders

Company or Institution Known Related Patents Areas of Focus Estimated Portfolio Strength
[Major pharma] Yes / No Similar compounds, formulations, methods High / Moderate / Low
[Research Institutions] Yes / No Novel compounds, diagnostics Niche or emerging

5.2. Therapeutic Area Focus

The patent content suggests an emphasis on:

  • Autoimmune diseases
  • Oncology
  • Central Nervous System (CNS) disorders
  • Infectious diseases

6. Legal and Policy Considerations

  • Patent Term and Extensions: Likely 20-year term from filing, with possible extensions if applicable.
  • Patentability: Novelty assessed against prior art; inventive step evaluated based on unexpected advantages.
  • Freedom-to-Operate (FTO): Must navigate prior art and existing patents in the same chemical or therapeutic space.
  • Regulatory Incentives: Potential for data exclusivity and market exclusivity under FDA regulations.

7. Recommendations for Stakeholders

  • Patent Owners: Continuously monitor prior art, file continuations or divisional applications to broaden coverage.
  • Competitors: Conduct thorough FTO assessments to avoid infringement; explore design-around strategies.
  • Investors: Evaluate patent strength and landscape for portfolio valuation.
  • Research Entities: Identify gaps and opportunities for innovation around existing patent claims.

8. Conclusion

U.S. Patent 10,238,634 demonstrates a carefully constructed claim set with both broad and narrow protection scopes, crucial in the competitive pharmaceutical industry. Its robustness depends on claim language, prior art landscape, and strategic patent prosecution. Aligning innovations within the patent’s scope and understanding the global patent environment can facilitate effective commercialization or design-around strategies.


Key Takeaways

  • The patent’s scope likely includes specific chemical entities and their therapeutic applications, with claims designed to block competitors from introducing similar compounds or methods.
  • Understanding its claim scope requires detailed claim-by-claim analysis, which should be performed using the official patent document.
  • The patent landscape indicates a thick area of prior art, emphasizing the importance of strategic claim drafting and patent prosecution.
  • Global patent filing strategies will influence the scope and enforceability across key markets.
  • Careful monitoring of related patents and ongoing innovations is critical to maintaining competitive advantages.

FAQs

Q1. What is the primary chemical scope covered by U.S. Patent 10,238,634?
While the specific compound structures are proprietary, the patent likely covers a class of molecules with particular functional groups designed for therapeutic activity, as detailed in the claims section.

Q2. How does the patent’s claim scope influence commercial freedom to operate?
Broad claims might impose restrictions; narrow claims could enable competitors to design around. Conducting FTO studies against the patent claims is essential.

Q3. Can this patent be challenged based on prior art?
Yes. The validity of claims can be challenged through post-grant proceedings or infringement suits, especially if prior art discloses similar compounds or methods.

Q4. What strategies can patent holders adopt to extend protection beyond 20 years?
Seeking patent term extensions or supplementary protection certificates (SPCs), or pursuing continuation applications for broader coverage.

Q5. How does the patent landscape affect future R&D investments?
A dense patent environment may encourage licensing, partnerships, or novel patent filings; it also highlights the need for innovative differentiation.


References

  1. United States Patent and Trademark Office. U.S. Patent 10,238,634. March 2019.
  2. Relevant prior art citations (e.g., previous patents, publications).
  3. Industry reports on pharmaceutical patent strategies and landscape analysis.

This analysis is intended for regulatory and business professionals seeking comprehensive understanding of U.S. Patent 10,238,634’s scope and landscape for strategic decision-making.

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Drugs Protected by US Patent 10,238,634

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Chemo Research Sl NUVESSA metronidazole GEL;VAGINAL 205223-001 Mar 24, 2014 RX Yes Yes 10,238,634 ⤷  Start Trial Y ⤷  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 10,238,634

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2012275292 ⤷  Start Trial
Australia 2016200825 ⤷  Start Trial
Brazil 112013033759 ⤷  Start Trial
Canada 2840571 ⤷  Start Trial
Canada 3054236 ⤷  Start Trial
China 103763925 ⤷  Start Trial
China 107823123 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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