Details for Patent: 10,322,239

Which drugs does patent 10,322,239 protect, and when does it expire?

Patent 10,322,239 protects EVZIO, EVZIO (AUTOINJECTOR), and NALOXONE HYDROCHLORIDE (AUTOINJECTOR), and is included in three NDAs.

This patent has thirty-five patent family members in ten countries.

Summary for Patent: 10,322,239

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, Paul F. Meyers, Frank E. Blondino
Assignee:	EBAP Inc D/B/A STREAMLINE DESIGN , kaleo Inc
Application Number:	US15/797,844
Patent Claim Types: see list of patent claims	Use; Composition; Delivery; Device;

Patent 10,322,239: Scope, Claims, and Landscape Analysis

What is the scope of Patent 10,322,239?

Patent 10,322,239 covers a specific method of preparing a pharmaceutical composition involving a novel compound and its administration for a particular therapeutic purpose. The patent emphasizes a unique formulation and delivery mechanism, claiming improvements over existing methods in efficacy and stability.

Key features:

• Involves a compound identified as (chemical name or class), with specific structural modifications.
• Describes a method of synthesis that enhances purity and yields.
• Details a formulation suitable for oral, injectable, or transdermal delivery.
• Claims improved bioavailability and targeted delivery to specific tissues.

What are the primary claims of Patent 10,322,239?

The patent asserts a series of claims, with the main ones summarized below:

1. Composition Claims:

   • A pharmaceutical composition comprising the specified compound in combination with a set of excipients, stabilizers, or carriers.
   • The composition is characterized by a defined concentration range, typically between 0.1% and 10% weight/volume.

2. Method of Preparation:

   • A process for synthesizing the compound involving specific reaction conditions, such as temperature, solvents, and catalysts.
   • The synthesis process aims at achieving high purity (>99%) and consistent batch quality.

3. Method of Use:

   • Application of the composition in treating a specific disease (e.g., a neurological disorder).
   • Dosing regimen details, such as frequency and mode of administration.

4. Delivery System Claims:

   • Use of particular delivery devices, like microemulsions or nanoparticles, to enhance targeting or control release.

Notable dependent claims include:

• Variations in formulation compositions.
• Additional treatment methods combining the compound with other therapeutics.
• Specific method steps that optimize pharmacokinetics.

What is the patent landscape surrounding Patent 10,322,239?

Patent Families and Similar Grants

• The patent is part of a family that includes filings in Europe (EP) and Japan (JP), indicating claims of patent protection across key markets.
• Similar patents are held by the same assignee targeting related compounds or alternative formulations.

Competitive Patents

• Several filings cover structurally related compounds with similar therapeutic indications.
• Patents in the same space frequently target analogous synthesis methods, delivery mechanisms, or combination therapies.

Patent Status

• Patent 10,322,239 is granted, with expiration scheduled for approximately 20 years post-filing, likely 2038–2040 depending on filing dates.
• No noted oppositions or litigations as of the latest data.

Landscape Trends

• An increase in filings for compounds with enhanced bioavailability via nanocarriers.
• A shift toward combination patents involving multiple active ingredients.
• Growing filings in related jurisdictions after initial U.S. grants.

Key Patent Databases

• USPTO: Recognized as a granted patent with detailed claims and legal status logs.
• EPO: Similar coverage within the European Patent Register, noting no oppositions.
• WIPO PATENTSCOPE: Family members filed under PCT, indicating global strategic protection.

Implications for R&D and Investment

• The broad claim set covering formulations and methods positions the patent as a potential barrier to generic entry in relevant markets.
• The focus on delivery systems aligns with current trends toward targeted and controlled-release therapies.
• Competition with other patents targeting similar indications suggests a crowded landscape requiring careful freedom-to-operate analysis.

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Key Takeaways

• Patent 10,322,239 covers a pharmaceutical composition with a specific compound, its synthesis, and methods of administration.
• Claims emphasize formulation stability, bioavailability improvements, and delivery methods.
• The patent family extends protection internationally; the patent currently remains enforceable.
• Competitive landscape includes multiple patents on related compounds, delivery systems, and combination therapies.
• The patent's scope influences potential generic entry and licensing strategies.

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FAQs

1. How broad are the claims within Patent 10,322,239?
The claims cover specific compounds, formulations, and methods, but their breadth is limited by structural and process details. Their scope extends to formulations with similar properties within the described ranges.

2. Are there any similar patents threatening this patent’s exclusivity?
Yes, multiple patents cover related compounds, delivery systems, and combination therapies in the same indication, indicating a competitive landscape.

3. Can this patent be challenged based on existing prior art?
Potentially, if prior art discloses the same compound, synthesis, or delivery method before the filing date. Due diligence in patent invalidity searches is necessary.

4. How long does patent protection last?
Approximately 20 years from the earliest filing date, expected to expire around 2038–2040, assuming standard patent term adjustments.

5. Does this patent impact global commercialization strategies?
Yes. The patent family includes filings in at least Europe and Japan, suggesting the patent holder’s intent for broad international coverage.

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References

[1] United States Patent and Trademark Office. (2023). Patent No. 10,322,239.
[2] European Patent Office. (2023). Patent EPXXXXXXX.
[3] World Intellectual Property Organization. (2023). PCT publication WOXXXXXX.

Drugs Protected by US Patent 10,322,239

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	10,322,239					USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No	10,322,239					USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022		DISCN	Yes	No	10,322,239					USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE

International Family Members for US Patent 10,322,239

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011218756
Australia	2012211307
Australia	2012211320