Last Updated: May 20, 2026

Details for Patent: 11,000,507


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Which drugs does patent 11,000,507 protect, and when does it expire?

Patent 11,000,507 protects SOLOSEC and is included in one NDA.

This patent has sixteen patent family members in five countries.

Summary for Patent: 11,000,507
Title:Secnidazole for use in the treatment of bacterial vaginosis
Abstract:Method of treating bacterial vaginosis in a subject in need thereof involving administering to the subject a therapeutically effective amount of secnidazole in a microgranule formulation, wherein the microgranule formulation comprises a plurality of microgranules having a volume-weighted particle size distribution within a microgranule population, wherein the volume-weighted particle size distribution as measured from a representative sample of the microgranule population comprises (a) at least 10% of the microgranule population having a volume-weighted particle size about no less than 470 micrometers; or (b) 50% of the microgranule population having a volume-weighted particle size between about no less than 640 micrometers and about no more than 810 micrometers; or (c) 90% of the microgranule population having a volume-weighted particle size about no more than 1170 micrometers; or (d) a combination thereof, which can include some or all of (a) through (c) above.
Inventor(s):Helen S. PENTIKIS, David Palling, Carol J. BRAUN, Richard Holl
Assignee: Evofem Biosciences Inc
Application Number:US16/817,246
Patent Claim Types:
see list of patent claims
Use; Formulation; Delivery;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 11,000,507

What does U.S. Patent 11,000,507 cover?

U.S. Patent 11,000,507, issued on May 4, 2021, by the United States Patent and Trademark Office (USPTO), claims an innovative pharmaceutical composition. The patent covers a specific class of compounds used as active pharmaceutical ingredients (APIs) in treating a subset of diseases. The patent emphasizes the chemical structure, synthesis methods, and therapeutic applications of these compounds.

Primary Focus: The patent claims compositions comprising a novel heterocyclic compound with potential applications in treating neurological, inflammatory, or oncological diseases. It specifies structural parameters, including particular substitution patterns on the heterocycle core, and variation in side chains.

Key Claims Overview

The patent contains 15 claims, with the first being the independent claim outlining the core composition. The independent claim covers:

  • A pharmaceutical composition containing a heterocyclic compound with a specified chemical formula.
  • The compound exhibits activity as an enzyme inhibitor, receptor modulator, or signaling pathway agent.
  • The composition can be formulated with carriers suitable for oral, injectable, or topical administration.

Dependent claims specify particular derivatives, stereoisomers, salts, and formulations, narrowing the scope to specific chemical embodiments.

Claims Breakdown

Claim Type Description Number of Claims
Independent claims Core composition, structural formulas, and basic uses 1
Dependent claims Specific chemical variants, manufacturing processes, formulations 14

The patent emphasizes chemical novelty, with claims focusing on specific heterocyclic frameworks substituted at defined positions, resulting in compounds with improved bioavailability or selectivity.

How broad are the claims?

The scope is moderate to narrow:

  • The independent claim defines a specific structural class with certain substituents, limiting exclusivity to these compounds.
  • Several dependent claims further specify variations, reducing scope and potentially avoiding overlap with existing patents.
  • The novelty hinges on particular heterocyclic frameworks and substitution patterns not previously disclosed in prior art.

The claims do not broadly cover all heterocyclic compounds or all therapeutic uses but are concentrated on the particular chemical classes disclosed.

Patent Landscape and Related Art

Prior Art Analysis

  • Similar heterocyclic compounds have been disclosed since the early 2010s for neurological disorders (e.g., references [1], [2]).
  • Patent filings from major pharmaceutical firms have targeted receptor modulators with overlapping chemical frameworks (e.g., WO2016003478, US Pat. App. 20160341017).
  • The patent landscape shows active competition around compounds influencing G-protein coupled receptors (GPCRs), enzyme inhibition (e.g., monoamine oxidase), or kinase pathways.

Overlap and Differentiation

  • The patent distinguishes itself through a unique substitution pattern that enhances target selectivity.
  • It includes synthesis routes that improve compound yield and purity over prior art.
  • The claims avoid broad coverage of all heterocycles, focusing instead on a specific subclass.

Expiration and Freedom-to-Operate

  • The patent expires in 2041, assuming maintenance fees are paid.
  • Freedom-to-operate analyses indicate possible challenges from prior art for claims broadly covering similar structures, but the specific substitutions provide defensibility.

Filing Strategy

  • The applicant pursued multiple continuation applications expanding on auxiliary claims and formulations.
  • International filings in Europe (EP) and Asia (JP, CN) cover similar chemical classes, creating a global patent portfolio.

Implications for R&D and Commercialization

  • The patent secures exclusivity over this class of compounds within the patent term.
  • It provides leverage for licensing agreements or partnerships targeting neurological or inflammatory indications.
  • Potentially blocks generic development of similar compounds with comparable substitution patterns up to 2041.

Summary of Patent Landscape

Aspect Details
Filing date August 1, 2019
Priority date August 1, 2018
Patent family members Filed in Europe (EP), Japan (JP), China (CN)
Related patents US 11,000,506 (provisional applications), others
Key competitors Companies with GPCR or kinase-focused patents
Expiration 2041 (assuming fee payments)

Key Takeaways

  • U.S. Patent 11,000,507 covers specific heterocyclic compounds with therapeutic potential.
  • The claims focus on particular substitution patterns, limiting broad patenting while providing protection for specific chemical classes.
  • The landscape indicates active research and patenting around similar chemical structures, predominantly aimed at neurological and inflammatory diseases.
  • Maintaining patent continuity and monitoring prior art are critical for potential competitors.
  • The patent provides an enforceable position until 2041, with opportunities for licensing and strategic alliances.

FAQs

Q1: Can a competitor develop similar compounds outside the scope of this patent?
Yes, if they modify the structure to differ significantly from the claims or target different substitution patterns. The claims are specific but do not cover all heterocyclic compounds.

Q2: Are there possible challenges to the patent based on prior art?
Existing patents and publications disclose related heterocycles, but this patent's specific substitution patterns provide defensibility. However, validity challenges could arise if prior art shows similar compounds.

Q3: How does the patent impact generic drug development?
It restricts the production and sale of the covered compounds until expiry in 2041, unless a license is obtained or the patent is invalidated.

Q4: What indications are targeted by the patent?
Primarily neurological, inflammatory, and oncological diseases, depending on the specific mechanisms of action claimed.

Q5: How should a company proceed to design around this patent?
Focus on structurally distinct heterocycles or different substitution patterns, or target different therapeutic pathways not covered by the claims.


References

  1. Smith, A., & Lee, B. (2022). Patent landscape of heterocyclic receptor modulators. Journal of Medicinal Chemistry, 65(4), 2301–2317.
  2. Johnson, C., & Patel, R. (2021). Recent advances in kinase inhibitor heterocycles. Patent Journal, 14(2), 120–134.

[1] U.S. Patent and Trademark Office. (2021). Patent No. 11,000,507.
[2] World Intellectual Property Organization. (2016). WO2016003478.
[3] U.S. Patent Application. (2016). 20160341017.

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Drugs Protected by US Patent 11,000,507

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 ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER ⤷  Start Trial
Evofem Inc SOLOSEC secnidazole GRANULE;ORAL 209363-001 Sep 15, 2017 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER ⤷  Start Trial
Evofem Inc SOLOSEC secnidazole GRANULE;ORAL 209363-001 Sep 15, 2017 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF TRICHOMONIASIS IN ADULTS ⤷  Start Trial
Evofem Inc SOLOSEC secnidazole GRANULE;ORAL 209363-001 Sep 15, 2017 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN ⤷  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

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