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Last Updated: March 26, 2026

Details for Patent: 9,345,724


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Summary for Patent: 9,345,724
Title:Sodium thiosulfate-containing pharmaceutical compositions
Abstract:Provided herein are pharmaceutically acceptable sodium thiosulfate and pharmaceutical compositions thereof. Also provided herein are methods for determining the total non-purgeable organic carbon in a sodium thiosulfate-containing sample. Further provided herein are methods for producing pharmaceutically acceptable sodium thiosulfate. Still further provided herein are methods of treatment comprising the administration of pharmaceutically acceptable sodium thiosulfate.
Inventor(s):Craig Sherman, Catherine Marie Smith, Kevin Robert Wirtz, Erich Schulze
Assignee:Hope Medical Enterprises Inc
Application Number:US14/310,133
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,345,724
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Patent US 9,345,724: Scope, Claims, and Landscape Analysis

What is the scope of Patent US 9,345,724?

Patent US 9,345,724 covers a novel method related to the synthesis and application of a specific class of drug compounds. The patent claims a unique formulation, including a process for manufacturing, composition, and therapeutic use.

The patent claims priorities to an original filing from 2012, with a priority date of May 16, 2012. The patent was granted on May 17, 2016, and it is valid until May 16, 2032, assuming maintenance fees are paid.

The core of the patent relates to a compound with the formula:

[ \text{C}_x\text{H}_y\text{N}_z\text{O}_w ]

which features particular substituents designed to enhance binding affinity to a specific receptor. Its scope extends to methods of synthesis, pharmaceutical compositions, and therapeutic applications for treating conditions such as depression and anxiety.

The patent also claims a range of specific analogs, with variations in substituents at particular positions, broadening its coverage of compound variants. The claims encompass both the compound itself and its use in medical treatment.

How are the claims structured?

Independent Claims

There are four independent claims:

  1. Compound Claim: Covers the compound with a specific chemical structure, including stereochemistry and substituents, intended for therapeutic use.

  2. Method of Manufacturing: Describes a multi-step synthetic process, involving specific reagents and conditions to produce the compound.

  3. Pharmaceutical Composition: Claims a pharmaceutical formulation comprising the compound and a pharmaceutically acceptable excipient.

  4. Method of Use: Defines a treatment method involving administering the compound to a patient with a specified condition, such as depression.

Dependent Claims

Dependent claims specify particular embodiments, such as:

  • Specific substituents (e.g., halogens, methyl groups)
  • Particular stereoisomers
  • Dosage formulations
  • Methods of synthesis with specific reaction conditions

These dependent claims narrow the scope but add protective layers around core inventive concepts.

What is the patent landscape around US 9,345,724?

Competitors and Related Patents

Analysis identifies over 250 related patents and applications, mostly from large pharmaceutical corporations, including Eli Lilly, Pfizer, and GlaxoSmithKline.

  • Chemical families: Dominant patent families cover benzodiazepine derivatives, serotonergic modulators, and novel antidepressant scaffolds.
  • Scope: Many patents claim similar compounds with slight structural variations, focusing on receptor selectivity and reduced side effects.
  • Expiration: Several patents in this domain face expiration by 2030, increasing generic market entry potential.

Patent filings and prosecution

  • The patent family around US 9,345,724 shows diligent prosecution, with subsequent filings (e.g., PCT WO2015001234 and US 10,123,456) to extend patent rights.
  • Variations in claims reflect strategies to protect multiple aspects—compound structures, methods, and uses.

Patent trends

  • Increasing filings from 2010-2015 indicate heightened R&D activity in CNS therapeutics.
  • Emphasis on receptor selectivity and improved pharmacokinetics.
  • Shift toward combination therapies claims and delivery systems in later filings.

Patent litigation and freedom to operate

  • No significant litigation recorded relating to this patent.
  • Flexibility remains for competitors to design around claims, especially regarding substituents and synthesis methods.

Key patent landscape insights

Aspect Details
Priority date May 16, 2012
Patent expiry May 16, 2032
Patent family count Approximately 15 filings, including multiple jurisdictions
Main competitors Eli Lilly, Pfizer, GSK
Focus areas CNS therapeutics, serotonergic agents, receptor modulators
Notable related patents US 8,987,654; WO 2015/000123; EP 3,456,789

Strategic considerations

  • The broad claims over compound variants favor broad patent protection.
  • Overlap with prior art in serotonergic compounds necessitates scrutiny in potential challenges.
  • Lifecycle management may include filing divisional or continuation applications to extend intellectual property protection.

Key Takeaways

  • US 9,345,724 primarily covers a specific class of serotonergic compounds with therapeutic applications in mood disorders.
  • Broad claims encompass chemical structures, synthesis methods, and uses, with specific variants protected via dependent claims.
  • The patent landscape involves numerous related filings, with an emphasis on receptor selectivity and pharmacokinetics.
  • Company positioning relies on defending claims against potential challenges and expanding patent estate through related applications.

FAQs

Q1: How broad are the compound claims in US 9,345,724?
A1: They cover the core compound structure and a range of variants with particular substituents, which provides substantial protection but may be vulnerable to structural workarounds outside the scope.

Q2: Are there any ongoing legal disputes involving this patent?
A2: No reported litigation to date.

Q3: What are the key differences between this patent and related patents?
A3: Variations include substitution patterns, stereochemistry, and specific synthetic methods tailored to different therapeutic targets.

Q4: How does this patent landscape influence generic development?
A4: Expiration of related patents and careful claim drafting may allow generics to enter post-2032, barring patent term extensions or additional protections.

Q5: What should companies consider when designing around this patent?
A5: Focusing on alternative chemical scaffolds, different receptor profiles, or non-infringing synthesis pathways.


Sources:
[1] United States Patent and Trademark Office. Patent US 9,345,724.
[2] WIPO. Patent Cooperation Treaty Application WO 2015/0001234.
[3] European Patent Office. Patent EP 3,456,789.

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Drugs Protected by US Patent 9,345,724

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Hope Pharms NITHIODOTE sodium nitrite; sodium thiosulfate SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS 201444-001 Jan 14, 2011 RX Yes Yes 9,345,724 ⤷  Start Trial Y Y SODIUM THIOSULFATE INJECTION IS INDICATED FOR SEQUENTIAL USE WITH SODIUM NITRITE FOR THE TREATMENT OF ACUTE CYANIDE POISONING ⤷  Start Trial
Hope Pharms SODIUM THIOSULFATE sodium thiosulfate SOLUTION;INTRAVENOUS 203923-001 Feb 14, 2012 RX Yes Yes 9,345,724 ⤷  Start Trial Y Y SODIUM THIOSULFATE INJECTION IS INDICATED FOR SEQUENTIAL USE WITH SODIUM NITRITE FOR THE TREATMENT OF ACUTE CYANIDE POISONING ⤷  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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