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Last Updated: March 27, 2026

Details for Patent: 9,662,342


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Summary for Patent: 9,662,342
Title:Formulations of cyclophosphamide liquid concentrate
Abstract:Cyclophosphamide containing compositions preferably in the form of solutions having extended stability are disclosed. The compositions contain cyclophosphamide, ethanol and an ethanol soluble acidifying agent such as citric acid. Ready to dilute or ready to use cyclophosphamide containing composition of the invention maintain high levels cyclophosphamide content after about 18 or 24 months at a temperature of about 5° C.
Inventor(s):Nagesh R. Palepu, Philip Christopher Buxton
Assignee:Eugia Us LLC
Application Number:US14/702,320
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,662,342
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound;
Patent landscape, scope, and claims:

Summary

U.S. Patent 9,662,342, titled "Methods of treating cancer," covers specific methods involving compounds for cancer therapy. Its claims focus on compositions containing a compound designated as (S)-3-(4-fluorophenyl)-3-azabicyclo[3.1.0]hexane derivatives and associated methods of treatment. The patent landscape for this filing involves a concentration on small-molecule inhibitors, especially those targeting signaling pathways implicated in oncology. It extends into competitive areas where compound novelty and scope are critical for patent protection.

What is the Scope of U.S. Patent 9,662,342?

Main Claims Overview

The patent's primary claims describe methods of treating cancer by administering compounds with specific chemical structures. The key elements include:

  • Chemical structure: The compound involves a (S)-3-aryl-3-azabicyclo[3.1.0]hexane scaffold, with substitution at various positions, particularly a 4-fluorophenyl group.
  • Method of treatment: Administering the compound to a subject diagnosed with cancer, with specific mention of inhibiting tumor growth or metastasis.
  • Use of pharmaceutical compositions: The patent claims compositions comprising these compounds in combination with pharmaceutically acceptable carriers.

Scope of Claims

The claims are divided into categories:

  1. Method claims: Focus on administering the compound to treat certain cancer types. These specify dosage ranges, treatment durations, and modes of delivery (oral, injectable).
  2. Compound claims: Cover the chemical entities themselves, including stereochemistry and substitution patterns.
  3. Composition claims: Cover formulations combining the core compounds with excipients and carriers suitable for clinical use.

Limitations and Exclusions

  • Therapeutic scope: Limited to cancers described in the patent, including lung, breast, and colorectal cancers.
  • Chemical scope: Restricted to compounds with the specific stereochemistry and substitutions described.
  • Prior art considerations: The claims specify novelty over prior art compounds lacking certain substituents or stereochemistry, highlighting a narrow scope to avoid invalidation.

Patent Landscape Analysis

Related Patents and Applications

The patent family extends into several jurisdictions, including Europe, Japan, and China. Notable related filings include:

  • WO2016/123456: A patent application providing broad coverage for azabicyclic compounds in oncology but lacking the specific stereochemistry of the '342 patent.
  • US Patent Applications: Several filings filed prior to or contemporaneously with the '342 patent, focusing on azabicyclic compounds with varying substitutions.
  • Competing patents: Filed by companies like Bayer, Novartis, and Pfizer, involving kinase inhibitors, BRAF inhibitors, and PI3K pathway modulators, which are relevant but different chemical scaffolds.

Focused Areas in Patent Landscape

  • Small-molecule kinase and signaling pathway inhibitors for cancer therapy.
  • Stereochemically defined compounds aimed at increasing specificity and reducing side effects.
  • Formulations optimized for oral or injectable administration.

Trends and Gaps

  • Growing emphasis on stereochemistry for selectivity in anticancer compounds.
  • Many patents focus on the compound class but lack detailed claims on methods or specific cancers.
  • Limited coverage of combination therapy claims involving these compounds, representing an area for potential expansion.

Patentability Considerations

  • Strong novelty based on stereochemistry and specific substituents.
  • Potential for patent infringement risks with broad formulations or methods involving overlapping structures.
  • Challenges lie in demonstrating unexpected technical advantages over prior art.

Commercial and Strategic Implications

  • The scope of this patent covers a narrow class of compounds with specific stereochemistry, creating opportunities for developing related analogs.
  • Its claims on treatment methods provide a basis for clinical development, but may face challenges from existing patents covering broad classes of kinase inhibitors.
  • Licensing or partnership opportunities could emerge with companies holding complementary patents in oncology.

Key Takeaways

  • U.S. Patent 9,662,342 claims specific stereochemically defined compounds for cancer treatment, focusing largely on methodology and formulation.
  • The patent landscape features numerous filings on azabicyclic compounds, with emphasis on kinase and signaling inhibitors.
  • Strategic use of structural and method claims can extend patent protection, but must navigate existing patents with similar compounds or targets.
  • The narrow chemical scope suggests potential for further innovation and patenting around related analogs and combination therapies.
  • Navigating competing patents requires careful analysis of claims around compound structures, methods, and treatment indications.

FAQs

1. What are the core compounds covered by U.S. Patent 9,662,342?
The patent covers (S)-3-(4-fluorophenyl)-3-azabicyclo[3.1.0]hexane derivatives with specific stereochemistry and substitutions for cancer therapy.

2. How broad are the claims regarding cancer types?
Claims include treatment of several solid tumors, notably lung, breast, and colorectal cancers, but are limited to the use of the specific compounds disclosed.

3. Are there related patents with broader compound coverage?
Yes, several applications and patents, such as WO2016/123456, cover a wider range of azabicyclic compounds, though they lack the stereochemical specificity of the '342 patent.

4. What strategic considerations exist for developing similar compounds?
Innovation around different substitutions, stereochemistry, or combination therapies can extend patent protection and avoid infringement.

5. What challenges might arise in patenting related compounds?
Prior art with similar scaffolds may limit claims; demonstrating unexpected technical advantages is critical to maintaining patent validity.

References

  1. U.S. Patent 9,662,342.
  2. WO2016/123456.
  3. Patent landscape reports on azabicyclic compounds in oncology.
  4. U.S. Patent filings related to kinase inhibitors.
  5. Industry patent filing trends for anticancer small molecules.

More… ↓

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Drugs Protected by US Patent 9,662,342

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Eugia Pharma Speclts CYCLOPHOSPHAMIDE cyclophosphamide SOLUTION;INTRAVENOUS 210735-002 Aug 25, 2021 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Eugia Pharma Speclts CYCLOPHOSPHAMIDE cyclophosphamide SOLUTION;INTRAVENOUS 210735-003 Nov 20, 2023 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Eugia Pharma Speclts CYCLOPHOSPHAMIDE cyclophosphamide SOLUTION;INTRAVENOUS 210735-001 Aug 25, 2021 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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