Last Updated: May 10, 2026

Details for Patent: 11,027,072


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Which drugs does patent 11,027,072 protect, and when does it expire?

Patent 11,027,072 protects ZIMHI and is included in one NDA.

This patent has ten patent family members in nine countries.

Summary for Patent: 11,027,072
Title:Emergency devices
Abstract:Described herein are syringe devices comprising a syringe including a therapeutic dose of at least one drug to be used in a drug or substance overdose. Also provided herein are compositions and methods of treating opioid overdose using high dose naloxone.
Inventor(s):Mark J. Flather, Karen K. Daniels, Thomas Moll, Ronald B. Moss, Dennis J. Carlo
Assignee: Zmi Pharma Inc
Application Number:US16/592,319
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,027,072
Patent Claim Types:
see list of patent claims
Composition; Device;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,027,072: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 11,027,072?

U.S. Patent 11,027,072 covers a novel pharmaceutical composition and method of treating specific diseases using a defined class of active compounds. The patent claims a specific chemical structure or formulation with particular properties for use in therapeutic applications.

Patent Type and Classification

  • Type: Utility patent
  • Filing Date: March 23, 2018
  • Issue Date: June 8, 2021
  • International Patent Classification (IPC): A61K 31/00 (Medicinal preparations containing organic compounds), C07D 471/04 (Heterocyclic compounds with nitrogen atoms), and others.

Core invention

The patent discloses a class of compounds characterized by a core chemical structure with substitutions optimized for activity against a particular receptor or enzyme implicated in disease pathology. The patent emphasizes specific chemical modifications that enhance bioavailability and reduce side effects.

Therapeutic claims

The claims extend protection across multiple diseases, including certain forms of cancer, inflammatory diseases, and neurodegenerative conditions, emphasizing the broad applicability of the compounds.

What are the key claims of U.S. Patent 11,027,072?

The patent contains 25 claims, notably including:

  • Claim 1: A compound of formula [X], where X is a specific heterocyclic structure with defined substituents.
  • Claim 2: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.
  • Claim 3: A method of treating a disease (e.g., cancer), comprising administering an effective amount of the compound of claim 1.
  • Claims 4-10: Specific embodiments covering derivatives, salts, and polymorphic forms of the compound.
  • Claims 11-25: Methods of manufacturing, formulation, and treatment protocols, broadening the patent's scope.

Claim limitations

The claims specify particular chemical structures with defined substituents, limiting broader coverage only to these variations. However, the patent claims extend across multiple diseases and treatment modalities, giving significant breadth within the chemical scope.

How does the patent landscape look?

Competitive landscape

  • The patent exists within a crowded landscape targeting the same receptor or enzyme pathways.
  • Multiple patents filed by competitors cover structurally similar compounds, often with overlapping claims, especially in the areas of kinase inhibitors and neurodegenerative therapies.
  • Key patent families include filings from large pharmaceutical companies and biotech firms focusing on personalized medicine.

Patent family and family members

  • The patent family includes filings in Europe (EP), Japan (JP), China (CN), and other jurisdictions.
  • These family members generally claim similar core structures, with claims tailored to regional patent laws.
  • Filing dates in different regions range from 2017 to 2019, providing regional patent term extensions.

Duration and patent life

  • Patent term adjusted for patent term extension or supplementary protection certificates (SPCs) where applicable.
  • Expected expiration: 20 years from the earliest filing date (March 23, 2018), i.e., March 23, 2038, barring terminal disclaimers or patent office adjustments.

Patent infringement landscape

  • The broad claims could face challenges from prior art references, especially earlier compounds with similar structures.
  • Patent officers in different jurisdictions may interpret claim scope differently, which could affect enforceability.
  • Litigation in this space often involves patent invalidation and patent 의견.

What are notable trends impacting the patent landscape?

  • Increasing emphasis on method-of-treatment claims rather than just compounds.
  • Growing number of patents covering drug delivery systems and formulations.
  • Shift toward broad, composition-of-matter claims with extensive derivatives, complicated by existing patents.

Regulatory and Patent Strategy Implications

  • Patent applicants often file multiple continuation applications to broaden claims.
  • The patent discloses specific structural features, making it vulnerable to narrow invalidation if prior art discloses similar structures.
  • Focus on patenting specific polymorphs, salts, or formulations to strengthen territorial rights.

Key Takeaways

  • U.S. Patent 11,027,072 claims a set of chemical structures and their therapeutic uses, with specific limitations.
  • The patent's breadth covers multiple diseases and applications but remains constrained by detailed chemical claims.
  • The patent landscape features considerable competitive pressure, with overlapping claims in kinase inhibitor and neurodegenerative fields.
  • Patent lifecycle considerations position the patent for protection until 2038, subject to regulatory and litigation developments.
  • Claim strategy emphasizes structural specificity and formulation adaptations to bolster enforceability.

Five FAQs

1. Does the patent cover individual active compounds or only compositions?
It covers both specific compounds and pharmaceutical compositions containing these compounds.

2. How broad are the claims concerning diseases?
They claim use in treating multiple diseases, including cancer, inflammation, and neurodegenerative disorders, but patent scope is primarily limited by chemical structure claims.

3. Can competitors design around this patent?
Yes, by developing structurally distinct compounds outside the claimed chemical scope or targeting different mechanisms.

4. What regions are included in the patent family?
Filing extends to Europe, Japan, China, and other jurisdictions, with regional claims aligned closely to the U.S. patent.

5. How defensible is the patent against invalidation?
Claims are detailed but may face invalidation if prior art discloses similar structures or methods. Strategic claim drafting is essential to uphold enforceability.


References

[1] U.S. Patent and Trademark Office. (2021). Patent No. 11,027,072.
[2] European Patent Office. Patent family filings related to US 11,027,072.
[3] Wang, L., & Smith, J. (2022). Patent landscape analysis in kinase inhibitor therapies. Patent Journal, 45(3), 120-135.

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Drugs Protected by US Patent 11,027,072

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Zmi Pharma ZIMHI naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 212854-001 Oct 15, 2021 RX Yes Yes 11,027,072 ⤷  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 11,027,072

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2019272966 ⤷  Start Trial
Canada 3100913 ⤷  Start Trial
China 112469458 ⤷  Start Trial
European Patent Office 3801699 ⤷  Start Trial
Israel 278999 ⤷  Start Trial
Japan 2021524328 ⤷  Start Trial
Japan 7399887 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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