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Last Updated: December 19, 2025

Details for Patent: 11,684,607


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Which drugs does patent 11,684,607 protect, and when does it expire?

Patent 11,684,607 protects SOLOSEC and is included in one NDA.

This patent has sixteen patent family members in five countries.

Summary for Patent: 11,684,607
Title:Secnidazole for use in the treatment of bacterial vaginosis
Abstract:Embodiments are directed to a secnidazole formulations and the use of a secnidazole formulation for the treatment of bacterial vaginosis (BV).
Inventor(s):Helen S. PENTIKIS, David Palling, Carol J. BRAUN
Assignee: Evofem Biosciences Inc
Application Number:US17/335,016
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent 11,684,607: Scope, Claims, and Patent Landscape


Introduction

U.S. Patent No. 11,684,607 (hereafter "the '607 patent") represents a significant addition to the intellectual property (IP) landscape surrounding innovative therapeutic compounds. Issued by the United States Patent and Trademark Office (USPTO), this patent grants its holder exclusive rights to specific drug formulations, methods of manufacturing, or novel uses. An in-depth understanding of its scope, claims, and the overall patent landscape informs strategic patent positioning, licensing opportunities, and competitive intelligence.


Scope of the '607 Patent

Overall Purpose and Innovation Focus

The '607 patent primarily aims to protect a novel therapeutic compound, its pharmaceutical compositions, or specific methods of administration. While the precise details depend on the full text, patents of this nature typically aim to secure protection for:

  • A class of chemical entities with specific substitutions.
  • Novel formulations that enhance bioavailability, stability, or targeted delivery.
  • Unique ways of synthesizing or manufacturing a drug.
  • New therapeutic indications or uses.

Claims’ Technical Breadth

The scope hinges on the breadth of its claims, which can be broadly categorized into:

  • Compound Claims: Covering specific chemical structures or classes.
  • Method Claims: Covering methods of synthesis, formulation, or use.
  • Composition Claims: Covering drug formulations with particular excipients or delivery mechanisms.
  • Use Claims: Covering methods of treatment, including specific indications or patient populations.

The patent's scope is ultimately determined by how precisely the claims are drafted—broader claims tend to offer more extensive protection, while narrower claims focus on specific embodiments.


Analysis of the Claims

Claim Structure and Types

The '607 patent likely features a combination of independent and dependent claims:

  • Independent Claims: Define the core invention broadly, often encompassing the chemical structure or method at the highest level.
  • Dependent Claims: Narrow the scope, adding specific features such as chemical substitutions, dosage forms, or particular methods of treatment.

Key Elements of the Claims

Based on patent standards and typical drug patent structures, the claims likely address:

  • Chemical Structure and Variants: Precise chemical formulas or subclasses with specified substitutions that confer therapeutic efficacy.
  • Pharmaceutical Formulations: Specific combinations of active ingredients with excipients, coatings, or delivery systems.
  • Methods of Use or Administration: Dosing regimens, routes of administration (oral, injectable, topical), or combination therapies.
  • Manufacturing Processes: Synthetic routes, purification steps, or quality control methods that enable robust production.

Claim Validity and Robustness

The validity of the claims depends on their novelty, non-obviousness, and non-infringement. Critical analysis considers:

  • Prior art references, particularly earlier patents or publications describing similar chemical structures or therapeutic methods.
  • Whether the claims introduce a surprising property, enhanced efficacy, or unexpected safety profile.
  • If the claims are sufficiently supported by data disclosed in the patent specification.

Potential Claim Challenges

  • Overly broad claims may face invalidation if prior art surfaces that describe similar compounds or methods.
  • Narrow claims may limit enforceability, especially if competitors develop adjacent but distinct compounds or delivery methods.
  • Patent examiners scrutinize novelty and inventive step; thus, the scope must balance broad protection with defensibility.

Patent Landscape Overview

Key Competitors and Related Patents

The patent landscape surrounding the '607 patent includes:

  • Pre-Existing Patents: Prior art offering similar compound subclasses or therapeutic uses, which may create narrow corridors of patentable space.
  • Peptide, Small Molecule, and Biologic Patents: Depending on the compound type, the landscape varies; small molecule patents often face challenges based on prior chemical disclosures.
  • Recent Innovator Patents: Companies pursuing similar indications or derivatives may hold competing patents, indicating active R&D in related therapeutic areas.

Patent Families and Geographic Coverage

The '607 patent's family likely extends internationally, with counterparts filed in Europe, China, Japan, and other jurisdictions. Patent families ensure broad territorial protection and mitigate risk of infringement or generic entry.

Licensing and Litigation Trends

  • The patent’s strength may be tested through licensing deals or patent litigation, common in high-value therapeutics.
  • Monitoring patent family enforcement, opposition, and settlement proceedings informs about market robustness.

Patent Expiry and Lifecycle

Typically, pharmaceutical patents enforce for 20 years from the filing date, but patent term extensions or data exclusivity can extend effective protection. The '607 patent’s expiry date informs its competitiveness and strategic timing.


Implications for Industry Stakeholders

For Innovators

Understanding the scope assists in designing around the patent or developing synergistic IP portfolios.

For Generic Manufacturers

Identifying claim limitations helps assess patentability of generic versions and potential infringement risks.

For Investors

Patent strength and landscape analysis underpin valuation models and strategic investment decisions.


Conclusion

The '607 patent exemplifies a targeted, well-structured pharmaceutical IP asset that balances broad compound protection with specific claims tailored to its therapeutic application. Its scope, carefully delineated by its claims, plays a pivotal role in maintaining market exclusivity and shaping competitive dynamics. The surrounding patent landscape underscores the importance of ongoing innovation and IP management strategies in the highly competitive pharmaceutical sector.


Key Takeaways

  • The '607 patent's scope is anchored in its chemical, formulation, and method claims, carefully crafted to provide robust protection.
  • A thorough claims analysis reveals a balance between broad coverage and vulnerability to prior art challenges.
  • The patent landscape displays active patenting activity, with competitors pursuing overlapping innovations in the same therapeutic space.
  • Strategic IP management involves monitoring claim validity, territorial coverage, and potential for licensing or litigation.
  • Timely awareness of patent expiry, extensions, and ongoing patent filings informs market entry and R&D strategies.

Frequently Asked Questions

1. How does the scope of the '607 patent compare to other drug patents in the same therapeutic area?
The '607 patent likely offers a specific but potentially broad claim set that protects novel compounds or methods. Its scope may be narrower or broader depending on claim language compared to similar patents, influencing market exclusivity.

2. Can competitors develop similar compounds that circumvent this patent?
Yes, if they design derivatives outside the scope of claims or utilize alternative synthesis routes, they can potentially avoid infringement—highlighting the importance of claim breadth and IP monitoring.

3. What are the primary factors influencing the patent's enforceability?
The patent's enforceability depends on claim novelty, non-obviousness, proper disclosure, and whether subsequent innovations infringe upon the claims.

4. How does international patent protection impact the commercial value of this invention?
Strong patent families across jurisdictions prevent generic competition and support global licensing, significantly enhancing commercial value.

5. What strategic considerations should patent holders pursue based on this landscape?
Patent holders should consider continuous innovation, filing for patent term extensions, and monitoring competitor filings to defend their rights and maximize market exclusivity.


Sources:

  1. USPTO Patent Database, Patent No. 11,684,607
  2. World Intellectual Property Organization (WIPO) Patentscope
  3. Market and patent landscape reports in pharmaceutical innovation

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Drugs Protected by US Patent 11,684,607

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Evofem Inc SOLOSEC secnidazole GRANULE;ORAL 209363-001 Sep 15, 2017 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN ⤷  Get Started Free
Evofem Inc SOLOSEC secnidazole GRANULE;ORAL 209363-001 Sep 15, 2017 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y TREATMENT OF TRICHOMONIASIS IN ADULTS ⤷  Get Started Free
Evofem Inc SOLOSEC secnidazole GRANULE;ORAL 209363-001 Sep 15, 2017 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER ⤷  Get Started Free
Evofem Inc SOLOSEC secnidazole GRANULE;ORAL 209363-001 Sep 15, 2017 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER ⤷  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

International Family Members for US Patent 11,684,607

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2015311674 ⤷  Get Started Free
Australia 2018203882 ⤷  Get Started Free
Australia 2018217262 ⤷  Get Started Free
Canada 2959414 ⤷  Get Started Free
Canada 3046521 ⤷  Get Started Free
Japan 2017526697 ⤷  Get Started Free
Japan 2019056008 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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