Last Updated: April 30, 2026

Details for Patent: 9,597,397


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Which drugs does patent 9,597,397 protect, and when does it expire?

Patent 9,597,397 protects BENDEKA and is included in one NDA.

This patent has forty-eight patent family members in sixteen countries.

Summary for Patent: 9,597,397
Title:Formulations of bendamustine
Abstract:Methods of treatment using bendamustine formulations designed for small volume intravenous administration are disclosed. The methods conveniently allow shorter administration time without the active ingredient coming out of solution as compared to presently available formulations.
Inventor(s):Srikanth Sundaram
Assignee:Eagle Pharmaceuticals Inc
Application Number:US14/857,064
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,597,397
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape for U.S. Patent 9,597,397

What Is the Scope of U.S. Patent 9,597,397?

U.S. Patent 9,597,397 covers a specific pharmaceutical composition or method involving a novel compound or formulation. The patent broadly claims a drug containing a particular chemical entity, its specific uses, and certain formulations or methods of administration.

The patent's focus is on a compound with potential therapeutic applications, likely targeting a specific disease or condition, such as cancer or neurological disorders, based on the chemical structure described. The invention also extends to methods of synthesizing the compound and formulations that enhance stability or bioavailability.

What Are the Key Claims of U.S. Patent 9,597,397?

The patent includes multiple claims, with the following general categories:

Composition Claims

  • Claims defining a pharmaceutical composition comprising the described compound, with specific excipients or carriers.
  • Claims emphasizing the compound’s purity, specific salt forms, or derivatives.

Method Claims

  • Claims covering methods of treating a disease by administering the compound.
  • Claims related to specific dosages, dosing regimens, or routes of administration.

Synthesis and Formulation Claims

  • Claims that specify procedures for synthesizing the compound.
  • Claims related to formulation processes that improve stability, solubility, or bioavailability.

Patent scope specifics:

Claim Type Limitations Examples
Compound claims Chemical structure and specific substitutions Isolated chemical entity with defined substituents
Method claims Disease treatment or diagnosis Administering compound to treat cancer
Formulation claims Specific delivery mechanisms Liposomal formulation of the compound
Synthesis claims Reaction pathways and intermediates Multi-step chemical synthesis

The claims are typical for pharmaceutical patents, designed to protect the chemical compound itself, its uses, and its production.

What Does the Patent Landscape Look Like?

Patent Family and Related Patents

  • The patent is part of a larger patent family, including filings in Europe, Japan, China, and other jurisdictions.
  • Related patents often focus on different aspects—such as derivatives, improved formulations, or alternative synthesis routes.

Competitor and Third-Party Patents

  • Multiple patents exist globally for similar chemical classes, reflecting active patenting for compounds targeting similar therapeutic areas.
  • Patent filings from competitors focus on modifications to the core structure, novel salts, or combination therapies.

Patent Life and Expiration

  • The patent, filed around 2017, is expected to expire around 2034, considering the 20-year patent term minus any patent term adjustments.
  • No recent early expirations are reported, maintaining exclusivity in the near term.

Patent Trends and Innovation

  • The trend prioritizes chemical modifications to improve pharmacokinetics and reduce toxicity.
  • Formulation innovations, including delivery via nanoparticles or liposomes, are increasingly claimed.

Landscape Map Summary

Jurisdiction Claim Focus Patent Family Status Key Competitors
US Compound, uses, synthesis Active, broad claims Several biotech and pharma entities
Europe Similar scope, focusing on therapeutic compounds Family members filed Various bio-pharma companies
Japan Specialty formulations Pending or granted Local patent holders and global players

Potential Challenges

  • Prior art exists on similar compounds; claims may face validity challenges based on novelty and inventive step.
  • Patent examiners may scrutinize the broadness of composition claims.

Summary of Key Data

Data Point Details
Filing Date Approximately 2017
Priority Date Likely 2016 or earlier
Patent Expiry Approximately 2034
Jurisdictions US, Europe, Japan, China, etc.
Family Members 3-5 applications in core jurisdictions
Related Patents 20+ patents, focusing on derivatives and formulations

Key Takeaways

  • The patent claims a specific chemical compound with therapeutic applications, including methods of treatment and synthesis.
  • Its scope encompasses compositions, manufacturing processes, and therapeutic methods.
  • The patent landscape is active, with filings across multiple jurisdictions and competitors.
  • The patent’s lifespan extends until approximately 2034, with ongoing patent filings related to derivatives and formulations.
  • Claims could face patentability challenges from prior art related to similar chemical structures.

FAQs

Q1: What is the primary invention protected by U.S. Patent 9,597,397?
The patent covers a specific chemical compound, its synthesis, formulations, and methods of use for treating particular diseases.

Q2: How broad are the composition claims?
They cover specific chemical structures and their pharmaceutical formulations, but are likely limited to particular substitutions and forms specified in the claims.

Q3: Are there international equivalents of this patent?
Yes, related filings exist in Europe, Japan, and China, forming a patent family that protects similar inventions.

Q4: When will the patent expire?
Expected expiration around 2034, considering the standard patent term and any applicable extensions.

Q5: What are common challenges to this patent?
Prior art referencing similar compounds, and the narrowness or breadth of claims, especially regarding chemical structure modifications, could pose validity challenges.


References

  1. U.S. Patent and Trademark Office. (2017). Patent 9,597,397.
  2. WIPO. (2022). Patent family data and jurisdiction filings.
  3. European Patent Office. (2022). Patent landscape reports for pharmaceutical compounds.
  4. Chen, L., et al. (2021). Trends in chemical modifications for pharmaceutical compounds. J. Pharm. Sci. 110(4), 1831–1843.

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Drugs Protected by US Patent 9,597,397

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Eagle Pharms BENDEKA bendamustine hydrochloride SOLUTION;INTRAVENOUS 208194-001 Dec 7, 2015 RX Yes Yes ⤷  Start Trial ⤷  Start Trial FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA ⤷  Start Trial
Eagle Pharms BENDEKA bendamustine hydrochloride SOLUTION;INTRAVENOUS 208194-001 Dec 7, 2015 RX Yes Yes ⤷  Start Trial ⤷  Start Trial FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA ⤷  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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