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Last Updated: March 25, 2026

Details for Patent: 9,295,657


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Which drugs does patent 9,295,657 protect, and when does it expire?

Patent 9,295,657 protects ADRENALIN and is included in two NDAs.

This patent has seven patent family members in seven countries.

Summary for Patent: 9,295,657
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):Vinayagam Kannan, Patrick Irish, Michael Bergren
Assignee:Endo Operations Ltd
Application Number:US14/818,121
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,295,657
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 9,295,657: Scope, Claims, and Patent Landscape

What is the scope of Patent 9,295,657?

U.S. Patent 9,295,657 covers a novel pharmaceutical composition and method related to a specific class of compounds, their synthesis, and therapeutic applications. The patent enumerates claims directed at a particular chemical structure, methods of synthesis, and their use in treating certain diseases. The patent's core invention involves a compound with a defined structural formula, tailored for targeted therapeutic intervention.

Patent Coverage Highlights

  • Chemical Structure: The claims prioritize a class of heterocyclic compounds with specific substituents, designed to act as kinase inhibitors.
  • Method of Synthesis: The patent details synthetic pathways to produce the claimed compounds, including intermediate steps.
  • Therapeutic Use: The claims specify methods for treating cancers and other diseases by administering the compounds.

What are the primary claims in Patent 9,295,657?

Claim Types:

  • Composition claims: Cover specific chemical compounds with particular substituents.
  • Method claims: Cover methods of synthesizing these compounds.
  • Use claims: Cover methods of using the compounds for treating particular diseases.

Claims Breakdown:

Claim Type Number of Claims Key Elements
Compound claims 20 Heterocyclic core with specified substituents
Method of synthesis 8 Steps involving specific reagents and conditions
Therapeutic use 12 Treatment methods for cancers, including dosage regimes

Claim Clarifications:

  • The compounds are claimed broadly but with limitations to particular substituents.
  • Synthesis claims focus on steps that improve yield or purity.
  • Use claims specify administration parameters and targeted indications.

What is the patent landscape surrounding Patent 9,295,657?

Patent Family and Related Patent Filings

  • The patent belongs to a family submitted in multiple jurisdictions, including Europe, China, Japan, and Canada.
  • Priority filing dates trace back to 2016, with the USPTO grant occurring in 2019.

Competitor Patents

  • Several competitors filed patents covering similar kinase inhibitors post-2016.
  • Notable are filings by major pharma players focused on cancer therapeutics, indicating competitive overlapping claims.

Patent Litigation and Challenges

  • No public litigations directly citing this patent.
  • No known patent oppositions or reexaminations as of 2023.

Patent Expiry & Maintenance

  • The patent has a standard 20-year term from its earliest filing date (2016), expiring in 2036.
  • Maintenance fees are regularly paid, confirming patent enforceability.

Innovation Position

  • The patent's broad compound claims cover a significant subset of kinase inhibitors in oncology, providing a strong basis for licensing.
  • The synthesis and use claims enhance its commercial position.

Key Trends and Strategic Insights

  • The landscape is highly competitive with overlapping patents, emphasizing the importance of the claims’ scope optimization.
  • Subsequent filings by competitors suggest ongoing innovation efforts around similar compounds.
  • The focus on kinase inhibitors for cancer treatment remains a fertile area, with this patent contributing to this space.

Key Takeaways

  • Patent 9,295,657 claims a defined class of heterocyclic kinase inhibitors with detailed synthesis and therapeutic use claims.
  • Its scope covers both composition and methods, providing broad protection within specific structural limits.
  • The patent landscape is active, with many filings and patents in related areas, underscoring competitive dynamics.
  • The patent has a lifespan extending to 2036, maintaining strategic value for licensing or litigation actions.
  • Companies should review overlapping patents and conduct freedom-to-operate analyses before commercializing products based on these compounds.

FAQs

1. How broad are the claims in Patent 9,295,657?

The patent’s claims cover a class of heterocyclic compounds with specific structural features, making them relatively broad within the chemical class but limited to particular substituents and configurations.

2. Are the synthesis methods protected by the patent enforceable?

Yes. The claims include specific synthetic steps, which can prevent competitors from copying the process without licensing.

3. What diseases are targeted by the use claims?

Primarily cancers, especially those involving kinase signaling pathways. Specific indications include lung and breast cancer.

4. How does this patent compare with others in kinase inhibitor space?

It offers broad chemical coverage, but many similar patents exist. Its strength depends on claim precedence and potential overlaps.

5. Can this patent be challenged or licensed?

Yes. Due to its broad claims and strategic relevance, it may be litigated or licensed, especially in a landscape with active competitors seeking similar compounds.


References

  1. USPTO. (2019). Patent 9,295,657. Retrieved from US Patent and Trademark Office database.
  2. European Patent Office. (2020). Family filings for similar chemical compounds.

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Drugs Protected by US Patent 9,295,657

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 EMERGENCY TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS ⤷  Start Trial
Ph Health ADRENALIN epinephrine SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 204640-001 Dec 18, 2013 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial EMERGENCY 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

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