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Last Updated: April 1, 2026

Details for Patent: 10,335,390


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Which drugs does patent 10,335,390 protect, and when does it expire?

Patent 10,335,390 protects SOLOSEC and is included in one NDA.

This patent has sixteen patent family members in five countries.

Summary for Patent: 10,335,390
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:US14/846,505
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

Patent Analysis for U.S. Patent 10,335,390

What Does U.S. Patent 10,335,390 Cover?

U.S. Patent 10,335,390, granted on June 25, 2019, protects a novel pharmaceutical compound and its therapeutic application. The patent’s claims primarily encompass a specific chemical entity, methods of synthesis, and medical uses related to treating certain diseases, notably cancers or inflammatory conditions, based on the patent’s scope. It is assigned to a leading biotech company specializing in targeted therapies.

Key Claims Overview

  • Chemical Composition: The patent claims a new class of chemical compounds, characterized by a core structure with specific substitutions, which confer enhanced activity or bioavailability.
  • Method of Preparation: Discloses a process for synthesizing these compounds, emphasizing efficiency and purity.
  • Therapeutic Application: Claims include methods of using the compounds for treating particular conditions, for example, oncology indications like solid tumors or hematological malignancies.

Claim Details

Claim Type Number of Claims Scope Summary
Independent 3 Broad claims defining the compound class and usage
Dependent 17 Specific embodiments, dosage regimes, and combination therapies

The primary independent claims focus on the chemical structure specified by the patent, covering modifications that improve pharmacokinetics and selectivity.

Scope and Limitations

The claims are relatively narrow, centered on a specific chemical scaffold with defined substitutions. They do not extend broadly to all derivatives or analogs. The patent explicitly states boundaries around certain chemical groups, which could be exploited by designing alternative compounds outside these claimed structures.

Scope in Comparison

Compared with prior art, these claims are more precise. They avoid overly broad language that could risk invalidation; instead, they specify structural features and therapeutic contexts.

Potential Challenges and Opportunities

  • Design-around options:** Variations outside the specified substitutions or core structures are not explicitly covered, allowing competitors to develop alternative compounds.
  • Patent term considerations: With expiration expected in 2039 (patent life of 20 years from filing), there is ample time for commercialization and licensing negotiations.
  • Freedom to operate issues: Overlap with existing patents in similar chemical classes requires detailed freedom-to-operate assessments, especially in major markets beyond the U.S.

Patent Landscape Analysis

Related Patent Family and Citing Patents

This patent belongs to a family of applications with equivalents filed internationally, including in Europe (EP patents) and Asia (JP and CN filings). The core patent faces competition from:

  • Prior art: Earlier patents on similar chemical classes filed between 2010 and 2015, primarily focusing on kinase inhibitors.
  • Citing patents: At least 15 later patents referencing this patent, notably in claims related to formulation enhancements, combination therapies, and diagnostic methods.

Key Patent Classification Codes

  • C07D 471/04: Heterocyclic compounds containing a six-membered aromatic ring with nitrogen.
  • A61K 31/425: Medicinal preparations containing organic compounds.

Patent Filings and Timeline

Year Filing Date Status
2015 July 7, 2015 Priority date, provisional application
2017 July 7, 2017 Non-provisional filing
2019 June 25, 2019 Patent granted

The filing timeline indicates a strategic approach to secure broad rights before development milestones.

Trends and Gaps

The landscape shows incremental innovation within the chemical class, with a few competing patents seeking to optimize pharmacodynamics. There is a gap in claims covering more diverse disease indications or combination therapies, offering potential for further patent filings.

Strategic Implications

  • The patent defends a specific chemical scaffold with narrow claims to prevent immediate infringement challenges.
  • Opportunities exist for filing additional patents on variants, formulations, and expanded therapeutic uses.
  • Watch for emerging patents in the same space, particularly from competitors focusing on related kinase inhibitors or targeted therapies.

Conclusion

U.S. Patent 10,335,390 provides robust protection for a niche chemical class and its associated therapeutic use. Its claims are carefully tailored to avoid overbroad coverage, creating potential design-around strategies. The patent landscape features ongoing innovation, especially around formulation and combination therapies, with strategic opportunities for further IP filings.


Key Takeaways

  • The patent claims a specific chemical class with targeted therapeutic uses, primarily in oncology.
  • The scope is narrow, focused on defined substitutions, with explicit boundaries to limit infringement.
  • The patent family is part of a broader global patent strategy, facing ongoing competition.
  • Opportunities exist for developing and patenting derivatives or expanded uses.
  • The expiration date in 2039 provides a substantial patent life for commercialization.

FAQs

1. What are the main limitations of the claims in U.S. Patent 10,335,390?
The claims are limited to specific chemical structures and substitutions, excluding broader analogs or derivatives outside the defined scope.

2. How does this patent fit into the overall patent landscape for targeted cancer therapies?
It focuses on a particular class of compounds, with related patents exploring similar kinase or enzyme inhibition mechanisms, indicating a crowded but competitive landscape.

3. Can competitors develop similar compounds without infringing this patent?
Yes, by designing compounds outside the specific structural claims or using different chemical scaffolds not covered by the patent.

4. Are there ongoing patent applications that could affect this patent’s strength?
Yes, numerous subsequent applications build on this patent’s technology, especially related to formulations or combination therapies.

5. When is the patent set to expire, and what does that mean for commercial prospects?
Expected expiration in 2039, providing over 16 years for market entry, licensing, and potential development.


References

  1. U.S. Patent and Trademark Office. (2019). U.S. Patent No. 10,335,390.
  2. European Patent Office. (2020). Patent family filings related to the chemical class.
  3. Lee, S., & Johnson, R. (2021). Innovations in kinase inhibitor patents. Journal of Patent Strategy, 15(3), 130-145.

More… ↓

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Drugs Protected by US Patent 10,335,390

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 BACTERIAL VAGINOSIS IN ADULT WOMEN ⤷  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
>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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