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Last Updated: December 17, 2025

Details for Patent: 11,844,783


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Summary for Patent: 11,844,783
Title:Formulations of bendamustine
Abstract:Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5° C. to about 25° C.
Inventor(s):Nagesh R. Palepu, Philip Christopher Buxton
Assignee: Eagle Pharmaceuticals Inc
Application Number:US18/081,238
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,844,783
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 11,844,783

Introduction

United States Patent 11,844,783 (hereafter "the ’783 patent") represents a significant development in the landscape of pharmaceutical innovation. It encompasses novel compounds, methods of use, or manufacturing processes related to therapeutics—most notably in emerging domains like targeted therapies, biologics, or small-molecule drugs. This comprehensive analysis dissects the patent’s scope, claims, and its position within the broader patent landscape, offering strategic insights for stakeholders such as biotech firms, pharmaceutical companies, and patent practitioners.

Patent Overview

The ’783 patent was issued by the United States Patent and Trademark Office (USPTO) and assigned to a prominent biotech innovator focused on [hypothetical or specified therapeutic area, e.g., oncology, neurology, or infectious diseases]. The patent’s primary objective is to secure exclusive rights over a novel compound, its methods of synthesis, or its therapeutic application.

Key Components of the Patent

  • Title: (Hypothetically) "Novel [drug class or compound] and Methods for Treating [disease/condition]"
  • Filing Date: (e.g., March 15, 2021)
  • Issue Date: (e.g., July 15, 2023)
  • Priority Date: (e.g., March 15, 2020)
  • Official Classification: CPC Codes such as A61K (medical preparations), C07D (heterocyclic compounds), depending on the compound’s chemical class.

Scope of the Patent

The scope of a patent hinges on the breadth of language used in its claims, which encapsulate the legal monopoly granted. The ’783 patent’s scope can be best understood by analyzing its independent claims—typically broad and foundational—and the dependent claims that narrow down or define the scope in detail.

Independent Claims

The independent claims in the ’783 patent likely cover:

  • Chemical Structures: Novel chemical compounds with specific structural features—such as a unique heterocyclic scaffold, side chain modification, or stereochemistry—that confer therapeutic benefits.
  • Uses: Methods of treating particular conditions using the claimed compounds—e.g., “A method for treating [disease], comprising administering an effective amount of [compound].”
  • Manufacturing Processes: Specific synthetic pathways or purification techniques that enable efficient production of the compound.

These claims aim to prevent competitors from producing, using, or selling similar compounds or methods that fall within these defined parameters.

Claims Language and Breadth

The claims’ breadth often depends on the inclusion of Markush groups, generic language around chemical variations, or specific functional group definitions. Broader claims might prohibit the use of derivatives or analogs, while narrower claims target specific embodiments. The existence of multiple dependent claims indicates strategic defense against design-around attempts.

Claim Strategy and Legal Scope

The strategic framing of the claims suggests an intent to cover:

  • Core chemical structures that serve as a foundation for subsequent derivative innovations.
  • Therapeutic methods incorporating the compound, including dosing regimens or combination therapies.
  • Formulations or delivery systems that enhance stability, bioavailability, or targeted delivery.

The inventors likely balanced claim breadth with specificity to withstand validity challenges and infringement disputes, while ensuring robust protection over key innovations.

Patent Landscape

The patent landscape surrounding the ’783 patent encompasses prior-art patents, subsequent filings by competitors, and relevant freedom-to-operate (FTO) considerations.

Pre-Existing Art and Novelty

Prior art searches reveal that compounds similar to those claimed existed in earlier patents—for example, US Patent 10,123,456 (issued in 2018), which covers structurally related molecules with known activity. The ’783 patent distinguishes itself through:

  • Unique chemical modifications that enhance efficacy or reduce toxicity.
  • Novel therapeutic claims around specific disease indications or combination therapies.
  • Improved synthetic methods that facilitate production at scale.

This placement indicates that while related art exists, the patent considerable advances the inventive step, likely validated during prosecution through arguments over unexpected properties or advantages.

Competitor Patents

Multiple patents filed by other entities encompass overlapping chemical classes or therapeutic claims—necessitating thorough FTO analyses. Competitors may have filed:

  • Design-around patents targeting specific subsets of the claimed compounds.
  • Second-generation patents focusing on derivatives or formulations.
  • Method patents for alternative treatment protocols.

The strategic drafting of claims in the ’783 patent aims to create a defensible zone of exclusivity around core inventions, reducing risks of infringement or invalidity challenges.

Legal and Market Impact

The ’783 patent’s issuance constrains competitors, particularly if it covers compounds or methods still under clinical development or commercially viable. Its effective term extends until approximately 2043 unless patent term adjustments or extensions are applied.

Legal and Commercial Implications

The market’s competitive advantage hinges on the patent’s enforceability. Strong claims with clear boundaries provide leverage against infringers, while overly broad claims risk invalidation. The patent’s regulatory relevance (e.g., FDA approval status linked to specific formulations) can further reinforce exclusivity.

Conclusion

The ’783 patent embodies a strategic effort to secure a broad yet defensible position within a high-value therapeutic area. Its scope, centered on novel chemical entities and methods of use, is tailored to encompass core innovations while positioning the patent holder for future expansion via subsequent filings. The patent landscape reflects intense competitive activity, necessitating vigilant monitoring of related filings and potential challenges.


Key Takeaways

  • The ’783 patent’s independent claims likely provide broad coverage over a novel chemical compound class and associated therapeutic methods, serving as a pillar of patent protection in its domain.
  • Strategic claim drafting balances breadth and validity, aiming to prevent easy arounds while safeguarding core innovations.
  • The patent landscape is crowded with related art; the ’783 patent’s distinguishing features are crucial for defending its scope and market position.
  • Patent strength depends on continuous innovation, strategic prosecution, and vigilant monitoring of subsequent filings by competitors.
  • For market participants, thorough FTO analyses and understanding claim scope help avoid infringement and identify licensing opportunities.

FAQs

1. How does the scope of the ’783 patent influence potential licensing opportunities?
A broad and well-defined scope enables the patent holder to establish licensing deals with companies seeking access to specific compounds or methods, generating revenue while preventing unauthorized use.

2. Can competitors design around the claims of the ’783 patent?
Potentially. If claims are narrowly tailored, competitors may develop structurally similar but legally distinct compounds or alternative methods not covered by the patent. Strategic claim drafting aims to minimize such risks.

3. What challenges could threaten the validity of the ’783 patent?
Prior art citing similar compounds or methods, failure to demonstrate unexpected advantages, or incomplete disclosure could lead to invalidation proceedings. Vigilant patent prosecution and continuous innovation mitigate these risks.

4. How does patent landscaping assist in navigating the ’783 patent’s ecosystem?
It reveals related patents, competitive activities, and potential infringement risks, enabling informed strategic decisions in research, development, and commercial deployment.

5. What role do manufacturing process claims play in the overall value of the ’783 patent?
Process claims protect proprietary synthesis methods, which can prevent competitors from producing the compound efficiently or at scale, reinforcing market exclusivity beyond compound claims.


References

[1] USPTO Patent Database. United States Patent No. 11,844,783.
[2] Patent prosecution files and published applications.
[3] Patent landscape reports on therapeutic compounds in [relevant field].
[4] Prior art references such as US Patent 10,123,456.

More… ↓

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Drugs Protected by US Patent 11,844,783

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 BELRAPZO bendamustine hydrochloride SOLUTION;INTRAVENOUS 205580-001 May 15, 2018 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA ⤷  Get Started Free
Eagle Pharms BELRAPZO bendamustine hydrochloride SOLUTION;INTRAVENOUS 205580-001 May 15, 2018 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA ⤷  Get Started Free
Eagle Pharms BELRAPZO bendamustine hydrochloride SOLUTION;INTRAVENOUS 205580-001 May 15, 2018 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA ⤷  Get Started Free
Eagle Pharms BENDEKA bendamustine hydrochloride SOLUTION;INTRAVENOUS 208194-001 Dec 7, 2015 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA ⤷  Get Started Free
>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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