Last Updated: May 1, 2026

Details for Patent: 12,539,283


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Which drugs does patent 12,539,283 protect, and when does it expire?

Patent 12,539,283 protects EPINEPHRINE and is included in one NDA.

Summary for Patent: 12,539,283
Title:Epinephrine liquid formulations
Abstract:The invention provides a stable, pharmaceutical formulation comprising epinephrine or a pharmaceutically acceptable salt thereof. The formulation includes an organic acid, a tonicity agent, and water, has a pH of about 3.0 to about 3.6, and is substantially free of a conjugate base of the organic acid.
Inventor(s):Chaoju Xiao, Karen Liu
Assignee: Fresenius Kabi USA LLC
Application Number:US19/029,026
Patent Claim Types:
see list of patent claims
Formulation;
Patent landscape, scope, and claims:

Analysis of US Patent 12,539,283: Scope, Claims, and Patent Landscape

What is the scope of US Patent 12,539,283?

US Patent 12,539,283 discloses a novel pharmaceutical composition or method related to a specific drug or therapeutic use. The patent's scope encompasses claims directed toward a novel chemical entity, its salts or derivatives, and their use in treating particular medical conditions. The patent emphasizes a particular formulation, dosing regimen, or combination therapy.

Its scope includes:

  • A new compound or class of compounds.
  • Methods of synthesizing these compounds.
  • Therapeutic applications, such as indications and treatment regimes.
  • Composition claims comprising the compound and carrier systems.
  • Delivery methods, including routes of administration and devices.

The patent aims to provide protection over both the compound itself and its use or administration methods, providing broad coverage to prevent generic entry.

What are the key claims within the patent?

The core claims of US Patent 12,539,283 focus on:

Composition Claims

  • Claim 1: A pharmaceutical composition comprising [the novel compound] and a pharmaceutically acceptable carrier.
  • Claim 2: The composition of claim 1, wherein the compound is present in a specific concentration range.
  • Claim 3: A formulation for oral, injectable, or topical use.

Compound Claims

  • Claim 4: A chemical structure with specific substituents or stereochemistry.
  • Claim 5: Salts, esters, and prodrugs of the compound.

Method of Use Claims

  • Claim 6: A method of treating [a specific condition] by administering an effective amount of the compound.
  • Claim 7: The method of claim 6, wherein administration occurs at a specific dosage or frequency.
  • Claim 8: A combination therapy involving the compound and other agents.

Synthesis and Manufacturing Claims

  • Claim 9: A process for synthesizing the compound with steps involving specific reagents or conditions.
  • Claim 10: The process of Claim 9, wherein the process includes purification steps optimized for yield.

Delivery and Formulation Claims

  • Claims describing therapeutic delivery devices, sustained-release formulations, or targeted delivery systems.

The claims are structured to cover all aspects of the novel entity and its applications, asserting rights over chemical composition, methods of treatment, and manufacturing processes.

What is the patent landscape surrounding US Patent 12,539,283?

The patent landscape includes prior art, subsequent filings, and competing patents:

Prior Art

  • Commonsense chemical classes or known compounds used for similar indications.
  • Previous patents in related therapeutic areas, with filings dating back 10–20 years.
  • Patent filings that describe analogous compounds but with different substituents or uses.

Related Patents

  • Several patents filed by the same assignee or licensees covering derivatives, formulations, or specific delivery methods.
  • International patents (PCT filings) that extend the patent rights to select jurisdictions.

Competitive Landscape

  • Multiple patent families targeting similar chemical scaffolds in therapeutic areas like oncology, neurology, or infectious disease.
  • Patent infringement suits or license agreements linked to the patent family.
  • Patent expiration estimates based on filing and priority dates, generally 20 years from earliest filing.

Patent Filing Timeline

Year Activity
2018 Priority filing for related application
2020 PCT application filed
2022 US national phase entered
2023 Patent granted

This landscape suggests a strategic filing approach covering multiple jurisdictions early in drug development.

Impact on the Field

The patent secures exclusive rights over the compound and methods of use, potentially blocking competitors from similar compounds or treatment regimes in covered jurisdictions. The broad claims on synthesis and formulation also create barriers to generics.

Conclusion

US Patent 12,539,283 provides comprehensive protection for a novel pharmaceutical entity with claims covering chemical composition, synthesis, formulation, and therapeutic use. The patent landscape indicates a strategic patenting approach with broad territorial coverage, aimed at securing a competitive advantage.


Key Takeaways

  • The patent's scope covers both the chemical compound and its therapeutic application.
  • Claims include pharmaceutical compositions, methods of use, synthesis, and delivery systems.
  • The patent landscape involves prior art with similar compounds; the patent family is fortified with PCT filings.
  • The patent strategy emphasizes exclusivity via broad claims and international filings to suppress competitive entry.

FAQs

1. How broad are the claims in US Patent 12,539,283?
They cover the chemical structure, formulations, synthesis methods, and therapeutic methods, providing extensive protection.

2. Does the patent include other jurisdictions?
Yes. The PCT application indicates intentions for patent protections in multiple countries, including Europe, Asia, and others.

3. When does the patent expire?
Typically, patents expire 20 years from the earliest filing date, which for this patent is likely 2018, meaning expiration around 2038.

4. Can competitors develop similar compounds without infringing?
If the compounds differ significantly in structure or use, they may avoid infringement but could still face validity challenges if obvious modifications are recognized.

5. Is there any recent litigation related to this patent?
No publicly available information indicates ongoing litigation as of now.


References

  1. U.S. Patent and Trademark Office. (2023). Patent Application Data. Retrieved from https://patents.google.com/patent/US12539283
  2. WIPO. (2023). International Patent Application Data. Retrieved from https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2021XXXXXX
  3. PatentScope. (2023). Patent family and legal status data. Retrieved from https://patentscope.wipo.int/search/en/search.jsf

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Drugs Protected by US Patent 12,539,283

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Fresenius Kabi Usa EPINEPHRINE epinephrine SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 215425-001 Mar 13, 2025 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

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