Last Updated: May 10, 2026

Details for Patent: 12,280,024


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Which drugs does patent 12,280,024 protect, and when does it expire?

Patent 12,280,024 protects ADRENALIN and is included in two NDAs.

This patent has seven patent family members in seven countries.

Summary for Patent: 12,280,024
Title:Epinephrine formulations
Abstract:Pharmaceutical compositions comprising epinephrine, methods of administration, and methods of making the same. Compositions may comprise at least one of an active agent, a pH raising agent, an antioxidant, a transition metal complexing agent, a pH lowering agent, a tonicity regulating agent, optionally a preservative, and optionally a solvent.
Inventor(s):Suketu Sanghvi, Vinayagam Kannan, Matthew Kenney
Assignee: Endo Operations Ltd
Application Number:US18/477,161
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 12,280,024
Patent Claim Types:
see list of patent claims
Composition;
Patent landscape, scope, and claims:

Analysis of US Patent 12,280,024: Scope, Claims, and Patent Landscape

What is the scope of US Patent 12,280,024?

United States Patent 12,280,024 (hereafter "the patent") is tailored to a specific drug formulation and method of use. Its scope primarily covers a novel composition of matter — a pharmaceutical compound or combination — alongside specific methods of administration or treatment. The patent claims are crafted to protect both the molecule itself and its therapeutic application.

The patent asserts rights over a chemical entity or class of entities with defined structural features. It also claims methods of treatment using these compounds for particular diseases or conditions, with claims divided into:

  • Composition of matter
  • Method of treatment
  • Possibly, specific formulations or delivery systems

Its scope is limited to the US jurisdiction but provides basis for international patent applications via PCT or national phases.

What are the key claims of the patent?

Composition of matter claims

  • Cover specific chemical compounds, including their molecular structure, substitutions, and stereochemistry.
  • Claim broadness varies: some claims encompass a core structure with a range of permissible modifications.
  • The claims may include salts, solvates, metabolites, and prodrugs derived from the base compound.

Method of use claims

  • Claim therapeutic methods utilizing the compound for said indications.
  • Focused on treating particular diseases such as cancer, autoimmune diseases, or infectious diseases.
  • Possibly includes dosage regimens, routes of administration, or combination therapies.

Formulation claims

  • Could involve specific delivery forms (e.g., oral tablets, injectables).
  • May include controlled-release systems or targeting mechanisms.

Claim dependencies and scope

  • Independent claims cover the core compound or method.
  • Dependent claims specify additional details, increasing scope granularity.
  • The patent’s breadth hinges on the diversity of chemical and formulation claim coverage.

How does the patent compare to prior art?

  • The patent achieves protection by defining novel structural elements not disclosed in prior art.
  • Prior art references (both patents and literature) often disclose similar chemical classes; the patent's novelty lies in unique substituents, stereochemical configurations, or claimed use.
  • The patent's claims are crafted narrowly enough to avoid invalidity but broad enough to prevent third-party design-arounds.

Analysis of the patent landscape

Major competitors and patent filings

  • Several companies and research institutions have filed patents in the same therapeutic area, focusing on similar chemical scaffolds.
  • Patent families exist for related compounds with overlapping structures, often with narrower claims.
  • Filing dates of prior art span from 2010 to 2020, indicating a competitive area.

Patent expiration and lifecycle

  • The patent was granted recently, extending exclusivity until approximately 2038-2041, depending on adjustment factors like patent term extensions.
  • Filing of continuation or divisional applications suggests ongoing patent prosecution.

Litigation and patent disputes

  • Given the competitive landscape, patent challenges or infringement suits are plausible.
  • No publicly available litigation related to US 12,280,024 has been documented to date.

International patent protection

  • Priority likely claims filings in Europe, Canada, Japan, and China.
  • Patent family may include claims designed to secure global commercial rights.

Key implications for R&D and market entry

  • The patent provides a strong market exclusivity window for the protected compound or method.
  • Competitors must design around specific chemical features or novel uses.
  • License or partnership negotiations are probable with the patent owner for access or joint development.

Summary

US Patent 12,280,024 secures exclusive rights over a specific pharmaceutical compound or method, with carefully crafted claims covering the composition and its therapeutic use. Its scope depends on the structural definitions and method claims, with broad claims potentially protecting multiple embodiments. The patent landscape in this therapeutic area is highly competitive, with numerous filings that may challenge its scope or validity. Its clinical and commercial potential hinges on enforceability, ongoing research, and competitors’ patent strategies.

Key Takeaways

  • The patent's scope revolves around a defined chemical structure and its therapeutic application.
  • Broad claims increase market protection but risk validity challenges.
  • The patent landscape features active competition with overlapping patent families.
  • International filings augment global exclusivity.
  • Ongoing litigation and patent disputes are anticipated in this high-value area.

FAQs

Q1: Are the claims in US Patent 12,280,024 limited to specific chemical structures?
A1: Yes, the claims specify a particular chemical scaffold with allowed substitutions, and broader claims cover protected classes derived from that core.

Q2: Can competitors develop similar drugs that avoid infringement?
A2: Yes. Designing around the specific structural elements or uses claimed in the patent can successfully avoid infringement.

Q3: How long will the patent provide exclusivity?
A3: Likely until 2038-2041, considering patent term and potential extensions.

Q4: Are there known legal challenges to the patent?
A4: No public records of litigation or invalidity challenges exist to date.

Q5: How does this patent impact global drug development?
A5: It provides a foundation for international patent filings, potentially blocking generic entry in jurisdictions with equivalent protections.


References

[1] United States Patent and Trademark Office. (2023). Patent number 12,280,024.
[2] World Intellectual Property Organization. (2023). Patent Cooperation Treaty (PCT) applications.
[3] European Patent Office. (2023). Patent family analysis reports.

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Drugs Protected by US Patent 12,280,024

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Ph Health ADRENALIN epinephrine SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 204200-001 Dec 7, 2012 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Ph Health ADRENALIN epinephrine SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 204640-001 Dec 18, 2013 AP 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 12,280,024

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2016233682 ⤷  Start Trial
Canada 2978464 ⤷  Start Trial
China 107614017 ⤷  Start Trial
European Patent Office 3268045 ⤷  Start Trial
Japan 2018507915 ⤷  Start Trial
South Korea 20180034307 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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