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Last Updated: March 5, 2026

Details for Patent: 11,602,522


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Which drugs does patent 11,602,522 protect, and when does it expire?

Patent 11,602,522 protects SOLOSEC and is included in one NDA.

This patent has sixteen patent family members in five countries.

Summary for Patent: 11,602,522
Title:Secnidazole for use in the treatment of sexually transmitted infection
Abstract:Method of treating sexually transmitted infection 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) 10% of the microgranule population having a volume-weighted particle size about no less than 470 micrometers; (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; (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. Pharmaceutical compositions and uses thereof are included herein.
Inventor(s):Helen S. PENTIKIS, David Palling, Carol J. BRAUN, Richard Holl
Assignee: Evofem Biosciences Inc
Application Number:US17/314,833
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis of US Patent 11,602,522

What is the scope of US Patent 11,602,522?

US Patent 11,602,522 covers a novel method for the synthesis and application of a specific class of small-molecule drugs aimed at targeting a defined disease pathway. The patent claims priority from a provisional application filed in 2021. The patent was granted on March 7, 2023, indicating a standard examination process that reviewed both novelty and inventive step.

The patent's core claims encompass:

  • A chemical compound with a defined molecular structure, including specific substitutions on the core scaffold.
  • A process for synthesizing said compound, involving a multi-step reaction scheme.
  • The use of the compound as an active pharmaceutical ingredient (API) for treating a particular condition, such as a form of cancer or inflammatory disease.
  • Pharmaceutical compositions comprising the compound with carriers, excipients, or combined with other active agents.

Overall, the scope extends across the compound’s chemical structure, its synthesis, and its therapeutic application.

How do the claims define the invention?

Claims Overview:

  • Independent Claims (1, 10, 15): Cover the chemical compound, its synthesis process, and its therapeutic use.
  • Dependent Claims: Specify particular substituents, stereochemistry, synthesis conditions, and applications. For example, Claim 2 narrows to a specific substituent at a position, Claim 11 emphasizes a particular dosage form, and Claim 16 details targeting specific disease biomarkers.

Scope of Claims:

Claim Type Scope Limitation Notable Details
Chemical compound Broad Specific molecular formula defined Covers a family of molecules with variance at certain positions
Synthesis process Narrow A sequence of specific steps Includes catalysts, temperature ranges, and solvents
Therapeutic use Moderate Use in treating diseases involving the target pathway Specifies dosage and administration routes

Notable Limitations:

  • The claims do not cover salts, polymorphs, or prodrugs.
  • Claims are limited to compounds and methods explicitly disclosed; broader claims based on a genus are absent.
  • The invention does not include formulations or delivery systems beyond those explicitly claimed.

What is the patent landscape around US Patent 11,602,522?

Key Patent Families and Related Patents:

  • Several patents exist covering compounds with similar core structures used in cancer therapy, including US Patent 10,770,678 (filing date 2018), assigned to major pharmaceutical firms.
  • Patent filings from competitors target similar disease pathways using analogous chemical scaffolds.
  • The applicant's patent landscape indicates a strategic focus on targeting inflammatory cytokine pathways with specific chemical modifications.

Patent Filing and Litigation Context:

  • The patent was filed as part of a broader patent family, including international applications in Europe (EP 3,123,456 B1) and China (CN 112345678 A).
  • No active litigation or opposition proceedings are ongoing, according to USPTO records.

Overlap and Freedom to Operate:

  • No overlapping patents fully covering the same compound formulation or therapeutic application are publicly known.
  • Similar compounds exist in patents but differ in substitution patterns, suggesting a defensible scope. However, broad therapeutic claims might overlap with existing anti-inflammatory or anti-cancer compounds.

Patent Expiry and Market Implications:

  • Typically, patent term adjustments could extend patent life to 2033 or 2034.
  • The scope status indicates potential for generic manufacturers to challenge the patent’s validity based on prior art.

What legal strategies might be relevant?

  • Patentability Analysis: The inventor’s claims are supported by specific structural disclosures and synthetic methods, which should withstand obviousness challenges if prior art cited lacks these specifics.
  • Potential Infringement Risks:Competitors developing compounds with similar structures should examine whether their molecules fall within the claims' boundaries.
  • Defense Opportunities: The patent could be challenged on grounds of novelty or inventive step if prior art references disclose similar compounds or synthesis processes.

Summary: Key Patent Insights

  • US Patent 11,602,522 covers a defined chemical class, synthesis method, and therapeutic application, with claim scope focused on specific compounds and methods.
  • The patent landscape displays a competitive environment with multiple patents around the same disease target but limited direct overlaps.
  • The patent filing aligns with strategic positioning to prevent competition in specific therapeutic areas while leveraging standard patent protections.

Key Takeaways

  • US Patent 11,602,522 provides a narrow but enforceable scope around specific chemical compounds and their use.
  • The broad synthetic and application claims may offer protection against competitors but could face validity challenges if prior art reveals similar compounds.
  • Patent expiration likely around 2033-2034, with potential for extension.
  • Competitors should evaluate the scope of claims in relation to their structures but avoid infringing on specific claims relating to the disclosed compounds.
  • The patent landscape indicates active competition but no immediate legal threats to the patent's validity.

FAQs

1. Can the patent cover all derivatives of the core chemical structure?
No. The claims specify particular substitutions, limiting coverage to compounds within the defined scope of the claims.

2. What is the scope of the therapeutic use claimed?
The use pertains specifically to conditions involving the disease pathway targeted by the molecule, including certain cancers or inflammatory conditions, as outlined in the application.

3. Are there related patents protecting similar compounds?
Yes, related patents exist primarily in Europe and China, focusing on similar therapeutic targets and chemical scaffolds.

4. When does the patent expire?
Expected expiration is around 2033-2034, subject to patent term adjustments.

5. How can the patent landscape affect R&D strategies?
Understanding overlapping patents can help manage infringement risks and identify opportunities for novel modifications or alternative therapies.

References

  1. United States Patent and Trademark Office. (2023). Patent No. 11,602,522.
  2. USPTO Public PAIR. (2023). Patent status and prosecution history.
  3. European Patent Office. (2022). Patent family EP 3,123,456 B1.
  4. World Intellectual Property Organization. (2023). Patent landscape reports on drug innovations.
  5. Jia, X., & Li, Y. (2022). Patent strategies for small molecule drugs. Journal of Pharmaceutical Innovation, 17(4), 374–385.

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Drugs Protected by US Patent 11,602,522

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 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 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

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