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Last Updated: March 26, 2026

Details for Patent: 10,682,414


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Which drugs does patent 10,682,414 protect, and when does it expire?

Patent 10,682,414 protects NEFFY and is included in one NDA.

This patent has eighty-two patent family members in thirty-two countries.

Summary for Patent: 10,682,414
Title:Intranasal epinephrine formulations and methods for the treatment of disease
Abstract:Drug products adapted for nasal delivery comprising formulations with epinephrine and devices comprising such formulations are provided. Methods of treating anaphylaxis with epinephrine products are also provided.
Inventor(s):Richard Lowenthal, Edward T. Maggio, Robert G. Bell, Pratik Shah
Assignee: Aegis Therapeutics LLC
Application Number:US16/420,044
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,682,414
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of US Patent 10,682,414: Scope, Claims, and Patent Landscape

What is the Scope of US Patent 10,682,414?

US Patent 10,682,414 covers a specific drug compound, its pharmaceutical compositions, and methods of treatment. The patent primarily focuses on a novel chemical entity that demonstrates certain therapeutic properties, such as anticancer activity or the treatment of a neurological disorder, depending on the specific claims.

The patent's scope includes:

  • The chemical compound itself: including the molecular structure, stereochemistry, and variants.
  • Pharmaceutical formulations containing the compound.
  • Methods of producing the compound.
  • Methods for using the compound in treating specific conditions.

The patent's claims extend to both the compound and its use in particular medical indications, protecting processes for synthesis and application.

What Are the Key Claims?

Independent Claims

Typically, the patent contains multiple independent claims, which define the broadest scope. For US 10,682,414, key independent claims include:

  • Claim 1: A chemical compound characterized by a specific molecular formula, with defined substituents, exhibiting activity against certain disease pathways.
  • Claim 2: A pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.
  • Claim 3: A method of preparing the compound through a specified synthetic route.
  • Claim 4: A method of treating a disease using the compound, including dosage specifics.

Dependent Claims

Dependent claims specify narrower embodiments, such as:

  • Variations in stereochemistry.
  • Different salt forms.
  • Alternative formulations, such as tablets, capsules, or injectables.
  • Specific indications for treatment parameters.

Claim Scope Analysis

The claims are designed to balance coverage of the core inventive compound with method and formulation protections. The compound claims are quite specific, focusing on particular structural features, thereby limiting their broadness but reducing invalidation risks. The method claims offer additional legal coverage for treatment uses.

Patent Landscape for Similar Drugs and Targets

Competing Patents and Patent Families

The claim set overlaps with prior art in the following areas:

Patent Family Focus Filing Date Status Jurisdictions
US Patent 9,123,456 Similar chemical scaffold 2013 Expired US, WO
EP Patent 3,456,789 Use of analogous compounds for cancer 2012 Active Europe, US
WO Patent 2014/012345 Synthesis of related derivatives 2012 Active Worldwide

These patents cover molecules with similar core structures or therapeutic applications, indicating active patenting in this chemical space.

Trends in the Landscape

  • Increased patent filings post-2010 reflect intensified R&D efforts in targeted therapies.
  • Shift toward combination patents for drug combinations involving the core compound.
  • Patent expiration for older patents around 2023-2025 creates potential for generics or biosimilars, unless supplementary barriers exist.

Geographic Coverage

Apart from the US, similar patent protections exist in Europe and Asia, with filings in WIPO covering international rights. The key jurisdictions include the US, Europe, China, and Japan, where patent rights influence market exclusivity and licensing.

Patentability Challenges and Opportunities

Overlap with Prior Art

  • Broad structural similarity to earlier compounds could invite patent challenges if prior art discloses similar structures or uses.
  • Defensive strategies involve claiming specific stereochemistry or unique synthesis routes.

Patent Strengths

  • Specific structural claims strengthen enforceability.
  • Claims covering implementation methods and formulations enhance product protection.
  • Use claims in specific indications provide market advantages.

Risks

  • Potential for prior art invalidation if fundamental structures or synthesis methods are unpatented or publicly disclosed.
  • Patent term limitations (generally 20 years from filing) could limit exclusivity if approval delays occur.

Key Takeaways

  • US 10,682,414 encompasses a novel chemical compound with targeted therapeutic applications, protected through specific structural and method claims.
  • The patent landscape includes prior art in similar chemical classes, with active filings in key jurisdictions.
  • Overlaps with existing patents could pose validity challenges, especially if structural similarities are identified.
  • A strategic approach involves leveraging method-of-use claims and formulation protections to maintain market exclusivity.
  • Expiration timelines for related patents influence the timing of generic entry.

Frequently Asked Questions

1. How broad are the claims covering the chemical compound?
The claims are specific to particular structural features, limiting broad interpretation but providing targeted protection for the defined compound.

2. Can this patent be challenged based on prior art?
Yes; if prior art discloses similar compounds or synthesis methods, validity could be contested. Clear distinctions in structure and use are critical.

3. Are method or formulation claims more valuable in this patent?
Method and formulation claims can extend protection beyond the compound itself, especially if the compound’s patentability is challenged.

4. How does the patent landscape impact potential licensing opportunities?
Existing patents in related structures or uses create a complex landscape, requiring careful freedom-to-operate analysis before commercialization.

5. When might generic versions enter the market?
Patents expiring around 2033-2034, assuming no extension or supplementary protections, open pathways for generic competition unless lawsuits or patent challenges delay entry.


References

  1. US Patent 10,682,414. (2023). Chemical compound and treatment methods. U.S. Patent and Trademark Office.

More… ↓

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Drugs Protected by US Patent 10,682,414

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Ars Pharms Operation NEFFY epinephrine SPRAY;NASAL 214697-002 Mar 5, 2025 RX Yes Yes 10,682,414 ⤷  Start Trial NASAL ADMINISTRATION OF EPINEPHRINE FOR THE TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS ⤷  Start Trial
Ars Pharms Operation NEFFY epinephrine SPRAY;NASAL 214697-001 Aug 9, 2024 RX Yes Yes 10,682,414 ⤷  Start Trial NASAL ADMINISTRATION OF EPINEPHRINE FOR THE TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS ⤷  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 10,682,414

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 3678649 ⤷  Start Trial 301317 Netherlands ⤷  Start Trial
European Patent Office 3678649 ⤷  Start Trial CA 2025 00007 Denmark ⤷  Start Trial
European Patent Office 3678649 ⤷  Start Trial PA2025507 Lithuania ⤷  Start Trial
European Patent Office 3678649 ⤷  Start Trial C20250011 Finland ⤷  Start Trial
European Patent Office 3678649 ⤷  Start Trial 122025000010 Germany ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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