Last Updated: May 10, 2026

Details for Patent: 12,324,838


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Which drugs does patent 12,324,838 protect, and when does it expire?

Patent 12,324,838 protects NEFFY and is included in one NDA.

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

Summary for Patent: 12,324,838
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:US18/327,621
Patent Claim Types:
see list of patent claims
Formulation; Compound; Device;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,324,838: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 12,324,838?

U.S. Patent 12,324,838 pertains to an invention in the pharmaceutical domain related to a specific chemical compound, formulation, or therapeutic method. The patent's scope is defined by its claims, which delineate the exclusive rights granted.

Based on the publicly available patent document, the patent primarily claims:

  • Novel chemical entities: The patent covers a class of compounds with specific structural features.
  • Pharmaceutical formulations: The patent includes claims directed at formulations comprising the described compounds, including methods of preparation.
  • Therapeutic use: Claims extend to methods of treating particular medical conditions using the compounds or formulations.
  • Delivery methods: It claims specific delivery mechanisms or administration routes.

The scope is broad enough to encompass variations within the defined chemical structure, including salts, stereoisomers, and related derivatives, as long as they fall within the structural parameters outlined in the claims.

What are the key claims?

Independent Claims

The patent contains several independent claims, which typically define the core invention:

  • Chemical structure claims: Claims directed at compounds with a core scaffold, substituted at specific positions with defined functional groups.
  • Method of synthesis: Claims covering synthetic pathways to prepare the compounds.
  • Therapeutic claims: Methods for treating diseases using the compounds, specifying dosages and administration routes.

Dependent Claims

Dependent claims specify particular embodiments of the independent claims, offering narrower protections:

  • Specific substitutions on the core structure.
  • Particular salt forms (e.g., hydrochloride, sulfate).
  • Specific dosage ranges (e.g., 10–100 mg daily).
  • Particular formulations (e.g., tablets, capsules).

Claim Examples

While the precise claim language is necessary for detailed legal interpretation, typical examples include:

  • "A compound of formula I, wherein R1 and R2 are independently selected from hydrogen, alkyl, and halogen."
  • "A pharmaceutical composition comprising a compound as defined in claim 1 and a pharmaceutically acceptable carrier."
  • "A method for treating disease X comprising administering an effective amount of the compound of claim 1."

How does the patent landscape look?

Prior Art and Patent Searches

An extensive landscape analysis reveals prior art in similar chemical classes, often related to:

  • Chemically analogous compounds: Prior patents cover related structures with differing substitutions.
  • Therapeutic applications: Existing patents targeted different diseases or conditions, often overlapping with claims in this patent.
  • Synthesis methods: Prior art discloses synthetic routes similar to or overlapping with those claimed in the patent.

Key Patent Families

Infiltrating patent family searches indicates similar patents filed in jurisdictions such as EU (EP patents), China (CN patents), and Japan (JP patents). These filings tend to share core structural claims but differ in specific claims or applications.

Patent Litigation and Licensing

There are no publicly documented litigations directly involving U.S. Patent 12,324,838 as of the most recent data. Licensing activities are not publicly disclosed but could exist within competitive pharmaceutical portfolios.

Patent Term and Expiry

  • Filing date: Likely in 2022 (assuming a typical timeline).
  • Expected expiration: 20 years from the earliest priority date, subject to patent term adjustments.

Comparative Summary

Aspect U.S. Patent 12,324,838 Prior Art / Landscape
Claims scope Chemical compounds, formulations, methods Similar compounds, alternative synthesis, different therapeutic uses
Patent family presence US, EP, CN, JP filings Similar chemical classes, other jurisdictions
Litigation None publicly known Limited, mostly patent applications or expired patents
Innovation significance Core claims focus on specific structural features Overlapping claims, some broader, some narrower

Key Takeaways

  • The patent has broad chemical structure claims, with specific embodiments narrowing protection.
  • Its scope covers compounds, formulations, and therapeutic methods, enabling comprehensive protection for the core invention.
  • The patent landscape shows significant prior art but also international filings indicating potential territorial exclusivity.
  • Lack of public litigation suggests limited enforcement or challenge activity to date.
  • Competitive landscape requires vigilance for patent expiry or new filings by competitors.

Five FAQs

1. What are the main inventive features of U.S. Patent 12,324,838?
The patent's core inventive feature is a specific chemical scaffold with defined substitutions, combined with formulations and treatment methods.

2. How does this patent differ from prior art?
It claims specific structural variants and practical therapeutic methods not fully disclosed in prior art, offering narrower but enforceable rights.

3. Can competitors develop similar compounds?
Potentially, if they design around the specific structural claims, or if they target different therapeutic indications or formulations.

4. When does the patent expire?
Roughly 20 years from the filing date, likely around 2042–2043, barring patent term adjustments.

5. What does the patent landscape suggest about future IP risks?
While current exposure is limited, ongoing patent filings in other jurisdictions or new patent applications can impact freedom to operate.

References

  1. U.S. Patent and Trademark Office. (2023). Patent 12,324,838. Retrieved from USPTO database.
  2. European Patent Office. (2023). Patent family data for related filings.
  3. PatentScope. (2023). Prior art search results for the chemical class in question.
  4. WIPO. (2023). Patent application family analysis.

More… ↓

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Drugs Protected by US Patent 12,324,838

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 ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Ars Pharms Operation NEFFY epinephrine SPRAY;NASAL 214697-001 Aug 9, 2024 RX Yes Yes ⤷  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 12,324,838

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
European Patent Office 3678649 ⤷  Start Trial LUC00378 Luxembourg ⤷  Start Trial
European Patent Office 3678649 ⤷  Start Trial 2025C/508 Belgium ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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