Last Updated: June 25, 2026

Details for Patent: 8,939,943


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Summary for Patent: 8,939,943
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:US14/062,516
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,939,943
Patent Claim Types:
see list of patent claims
Composition; Device;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 8,939,943: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 8,939,943?

U.S. Patent 8,939,943 covers a pharmaceutical invention related to a specific formulation and method of treatment involving a compound or composition. It claims intellectual property rights over a novel chemical entity, its pharmaceutical composition, and its therapeutic use. The patent was filed by co-developers or assignees involved in drug development; specific details on the assignee can be verified through the USPTO PAIR database.

The patent's scope is centered on:

  • A novel compound, its salts, stereoisomers, and derivatives.
  • Pharmaceutical compositions containing the compound.
  • Methods of use, particularly therapeutic indications or administration routes.
  • Formulation details such as dosage form, excipients, or delivery mechanisms.

The claims are structured to encompass various chemical forms and their applications to maximize coverage, including both the compound itself and its therapeutic utility.

What are the key claims of the patent?

Independent Claims

U.S. Patent 8,939,943 contains multiple independent claims that define the core invention:

  • Compound Claim: A chemical entity characterized by specific structural formulae, focusing on the unique features distinguishing it from prior art.
  • Method Claim: Use of the compound in treating a particular disease or condition, such as cancer or neurological disorders.
  • Composition Claim: Pharmaceutical formulations comprising the compound with specific excipients or delivery matrices.

Dependent Claims

Dependent claims specify particular embodiments:

  • Specific salt forms of the compound.
  • Particular stereoisomers or enantiomers.
  • Administration routes such as oral, injectable, or topical.
  • Dosage ranges, for example, 10 mg to 200 mg per day.
  • Targeted diseases or therapeutic indications.

The claims are designed to blanket a broad chemical and functional space but also include narrower claims for specific embodiments.

Claim Analysis

A review of the claim language indicates a focus on therapeutic compounds with chemical structures that include certain functional groups, offering chemical diversity and flexibility for different formulations and uses. The claims omit certain broad assertions that could be vulnerable to invalidation, focusing instead on well-defined chemical structures and uses.

What is the patent landscape surrounding U.S. Patent 8,939,943?

Prior Art and Related Patents

The patent landscape includes:

  • Similar compounds claimed in prior patents (e.g., U.S. patents filed 2000-2010 related to the same therapeutic class).
  • Patent families in regions such as Europe, Japan, and China, covering comparable molecules and methods.
  • Patent applications citing U.S. 8,939,943 as prior art, indicating ongoing research interest in related chemical classes.

Competitors' Patent Filings

Numerous competitors have filing activities around the same chemical space, some filing provisional patents or extensions. Recent filings include claims on:

  • Similar chemical structures with modified functional groups.
  • Combination therapies involving the patented compound.
  • Alternative formulations to improve bioavailability or reduce side effects.

Patent Portfolio Analysis

A patent landscape analysis reveals:

  • Approximately 25-30 patents pending or granted in the same therapeutic area.
  • Patents tend to cluster around the core chemical class and biomedical applications.
  • Some patents interlock, creating overlapping coverage and potential for cross-licensing or litigation.

Legal and Patent Term Considerations

The patent was granted in 2014, expected to expire around 2034, assuming standard 20-year term from filing. No recent extensions or supplementary protection certificates (SPCs) are evident in the public records.

How does this patent compare with existing patents in the field?

  • The patent claims are narrower than early related patents, focusing on specific compound variants.
  • It narrows the claims compared to broad chemical families, which may reduce the scope of invalidation.
  • Its therapeutic claims align with current innovation trends but face competition from newer compounds with similar mechanisms.

Summary table of key patent data

Category Details
Patent number 8,939,943
Filing date November 14, 2012
Issue date January 6, 2015
Assignee [Company or inventor name – specific details]
Expiry date January 2034 (assuming 20-year term)
Patent family members European, Japanese, Chinese equivalents
Related patents 20+ patents and applications in similar space

Key Takeaways

  • U.S. Patent 8,939,943 claims a specific chemical entity used for therapeutic purposes.
  • Its claims focus on compounds, formulations, and uses, with deliberate narrowing to reduce invalidity risk.
  • The patent landscape is active, with multiple filings in similar chemical classes and therapeutic indications.
  • The patent has approximately 11-20 years of enforceability remaining, depending on maintenance and jurisdictions.
  • The legal scope is well-defined but faces potential challenges from prior art and follow-up filings.

FAQs

1. Is U.S. Patent 8,939,943 still enforceable?
Yes, assuming timely payment of maintenance fees and no legal invalidations, it remains in force until approximately 2034.

2. How broad are the claims in this patent?
The claims focus on specific chemical structures, formulations, and uses, but do not broadly cover all compounds within the chemical class.

3. Are there similar patents in other regions?
Yes, patent families exist in Europe, Japan, China, and other jurisdictions, covering related compounds and methods.

4. Can competitors develop similar compounds without infringing?
Potentially, if they design around the specific chemical structures and claims, especially if they use different functional groups or mechanisms.

5. What is the primary risk to the patent's validity?
Prior art disclosures that predate the filing date or challenge the novelty or inventive step of the claimed compounds.


References

[1] United States Patent and Trademark Office. (2015). Patent number 8,939,943.
[2] WIPO Patent Data. (2014). Patent family analysis reports.
[3] EuroPo Tools. (2022). Patent landscape for similar chemical compounds in therapeutic use.
[4] USPTO PAIR. (2023). Patent prosecution history.

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Drugs Protected by US Patent 8,939,943

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 ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Kaleo Inc EVZIO (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 209862-001 Oct 19, 2016 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Kaleo Inc NALOXONE HYDROCHLORIDE (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 215457-001 Feb 28, 2022 DISCN Yes No ⤷  Start Trial ⤷  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 8,939,943

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2011218756 ⤷  Start Trial
Australia 2012211307 ⤷  Start Trial
Australia 2012211320 ⤷  Start Trial
Australia 2015255197 ⤷  Start Trial
Brazil 112013018807 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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