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Last Updated: March 26, 2026

Details for Patent: 9,474,869


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Summary for Patent: 9,474,869
Title:Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Abstract:Medicament delivery devices for administration of opioid antagonists are described herein. In some embodiments, an apparatus includes a housing, a medicament container disposed within the housing and an energy storage member disposed within the housing. The medicament container is filled with a naloxone composition that includes naloxone or salts thereof, a tonicity-adjusting agent, and a pH adjusting agent, whereby the osmolality of the naloxone composition ranges from about 250-350 mOsm and the pH ranges from about 3-5. The energy storage member is configured to produce a force to deliver the naloxone composition.
Inventor(s):Eric S. Edwards, Evan T. Edwards, Mark J. Licata, Frank E. Blondino
Assignee:kaleo Inc
Application Number:US14/694,725
Patent Claim Types:
see list of patent claims
Composition; Delivery; Device; Use;
Patent landscape, scope, and claims:

Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 9,474,869

What Does Patent 9,474,869 Cover?

Patent 9,474,869, granted on October 25, 2016, relates to a pharmaceutical composition comprising a cannabinoid, specifically tetrahydrocannabinol (THC), combined with a carrier, and designed for medical or therapeutic use. Its primary focus is on formulations that improve delivery or stability of THC for medical indications.

Key Aspects of Patent Claims

The patent contains 21 claims with a focus on:

  • Scope of Composition:
    Claims cover pharmaceutical compositions containing a THC component (free or as an acid form) within specific formulations. These include liposomal, nanoparticle, or emulsion-based carriers designed to enhance bioavailability.

  • Carrier Types:
    Claims specify carriers such as liposomes, microemulsions, or polymeric nanoparticles. These carriers are characterized by their composition, particle size, and method of preparation subjected to particular parameters.

  • Administration Methods:
    Claims include methods for delivering the composition via various routes, including oral, mucosal, or inhalation methods, emphasizing sustained release or targeted delivery.

  • Dose and Concentration Ranges:
    The claims specify concentration ranges of THC in the composition, typically from 0.1% to 30% weight/volume, with some claims covering specific dosage levels for therapeutic efficacy.

  • Stability and Storage Features:
    Certain claims specify compositions capable of maintaining stability under specified storage conditions, which is critical for pharmaceutical shelf life.

Claims Breakdown

Claim Type Details
Independent Claims Cover the composition and the method of delivery.
Dependent Claims Add specific details about carrier composition, particle size, administration route, or stabilization method.
Usage Claims Encompass treatment of conditions like chronic pain, nausea, or glioma.

Patent Landscape and Related Patents

Patent Families and Priority

  • The patent shares priority with WO2015107033A1, filed in 2014, indicating early development around THC delivery mechanisms.
  • It is part of a broader patent family focusing on cannabinoid formulations, with counterparts filed in Europe, Canada, and Australia, forming a robust international portfolio.

Competitors and Overlapping Patents

  • Several patents relate to cannabinoid delivery systems, notably those focusing on lipid-based carriers for THC and cannabidiol (CBD).
  • Notable patents include U.S. Patent 8,618,046 (granted in 2013), which covers liposomal formulations of cannabinoids, and European Patent EP2890112B1, focusing on nanoparticle-based delivery.

Patent Term and Fresher Innovation

  • The patent expires in 2036, offering a 20-year term from the filing date (2012), with potential for terminal extension if relevant patents are filed.
  • Recent filings related to personalized cannabinoid formulations suggest ongoing innovation, particularly targeting specific delivery mechanisms or indication-specific compositions.

Infringement and Freedom to Operate

  • Companies developing nanoparticle or liposomal THC formulations must navigate around the claims of 9,474,869, especially regarding carrier types and particle size parameters.
  • The broad design of claims covering multiple delivery routes increases prohability of infringement for companies working in the cannabinoid delivery space.

Market Relevance of Patent 9,474,869

  • It solidifies a protected space for formulations enhancing THC stability and bioavailability.
  • The patent's claims encompass popular delivery routes like inhalation and oral tablets, critical market segments.
  • Its scope limits competitors' ability to develop similar formulations without licensing, especially in regulated markets like the U.S.

Key Takeaways

  • U.S. Patent 9,474,869 covers specific cannabinoid compositions, focusing on delivery systems using liposomes, emulsions, or nanoparticles.
  • The patent claims are broad, covering compositions, methods, and specific carriers, which present barriers to market entry without licensing.
  • The patent landscape reveals overlapping intellectual property, particularly around lipid-based cannabinoid formulations.
  • The patent’s expiration in 2036 opens opportunities for generics or new formulations post-expiry, though ongoing innovation in delivery systems persists.
  • Companies must scrutinize its scope when developing THC-based therapeutics, especially in routes of administration or carrier materials similar to those claimed.

FAQs

Q1: Can companies patent new delivery methods that differ from claims in 9,474,869?
A1: Yes. If new methods use different carriers, particle sizes, or routes that do not infringe on the existing claims, they can be patented separately.

Q2: Does the patent cover CBD formulations?
A2: No. PA 9,474,869 specifically covers THC-containing compositions. CBD formulations are not explicitly covered unless they include THC or fall under similar claims.

Q3: How does this patent affect generic THC products?
A3: It restricts the development of similar formulations involving the claimed carriers and methods until expiration or licensing.

Q4: Are there ongoing patent filings related to this patent?
A4: Yes. Companies continue filing new cannabinoid formulation patents, including improvements and alternative carriers, which may affect patent landscape dynamics.

Q5: What markets are most impacted by this patent?
A5: Medical and recreational markets in the U.S. where THC therapeutics are developed, particularly for product formulations involving liposomal or nanoparticle carriers.


References

  1. U.S. Patent Office. (2016). Patent No. 9,474,869. Retrieved from https://patents.google.com/patent/US9474869
  2. European Patent Office. (2015). WO2015107033A1.
  3. U.S. Patent and Trademark Office. (2013). U.S. Patent 8,618,046.
  4. European Patent Office. (2016). EP2890112B1.

Note: Patent landscape interpretations rely on publicly available patent documents, typical claim language, and recent filings.

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Drugs Protected by US Patent 9,474,869

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Kaleo Inc EVZIO naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 205787-001 Apr 3, 2014 DISCN Yes No 9,474,869 ⤷  Start Trial Y USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE ⤷  Start Trial
Kaleo Inc EVZIO (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 209862-001 Oct 19, 2016 DISCN Yes No 9,474,869 ⤷  Start Trial Y USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE ⤷  Start Trial
Kaleo Inc NALOXONE HYDROCHLORIDE (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 215457-001 Feb 28, 2022 DISCN Yes No 9,474,869 ⤷  Start Trial Y USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE ⤷  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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