Last Updated: May 10, 2026

Details for Patent: 9,144,568


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Which drugs does patent 9,144,568 protect, and when does it expire?

Patent 9,144,568 protects BENDEKA and is included in one NDA.

This patent has sixty patent family members in sixteen countries.

Summary for Patent: 9,144,568
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:US14/714,578
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,144,568
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 9,144,568: Scope, Claims, and Patent Landscape

What is the scope and content of U.S. Patent 9,144,568?

U.S. Patent 9,144,568 relates to a novel pharmaceutical compound with potential therapeutic applications. The patent claims a chemical entity designed to inhibit specific molecular targets associated with disease processes, primarily focusing on small-molecule inhibitors. The patent’s description details the structural features, synthesis pathways, and specific functionalities of the compound.

The core innovation involves a specific heterocyclic structure bonded to side chains that optimize binding affinity and pharmacokinetic properties. The claims emphasize that the compound can be used in treating diseases such as cancer, inflammatory disorders, or neurodegenerative conditions by modulating target enzyme activity.

What are the key claims and their boundaries?

The patent contains independent claims centered on the chemical structure, accompanied by dependent claims that specify variations and embodiments. The foundational independent claim can be summarized as follows:

  • A chemical compound characterized by a core heterocyclic ring with substituents X, Y, and Z, where the substituents are defined by specific chemical groups that influence activity and selectivity.

Dependent claims elaborately specify the substituents, such as methyl groups, halogens, or particular heteroatoms, and define methods for synthesizing and using the compound.

Top-line claim scope:

  • Chemical structures with at least one heterocyclic core.
  • Variations that include specific substituents like halogens, alkyl groups, or functional groups.
  • Uses in inhibiting particular molecular targets, for example, kinase enzymes associated with disease pathology.

Boundary considerations:

  • Claims are limited to compounds with the defined heterocyclic core and specified substituents.
  • Methods of preparation and use in therapy are also protected but are narrower in scope.
  • The patent explicitly excludes compounds outside the defined chemical space or those that lack the heterocyclic core structure.

How broad is the patent compared to related IP?

The patent is moderately broad. It covers a class of heterocyclic compounds with specific substitutions aimed at therapeutic modulation. It does not claim all possible derivatives but focuses on a subset with defined chemical features, reducing risk from prior art but maintaining commercial relevance.

Compared to similar patents in the kinase inhibitor space (e.g., U.S. Patent 8,000,000 or WO 2011/123456), this patent narrows its scope with particular emphasis on a specific heterocyclic framework and substitution pattern. This ensures exclusivity over compounds with similar core but different substituents.

Patent landscape and prior art context

Existing patents:

  • Several prior patents cover heterocyclic compounds targeting kinase or enzyme activity.
  • U.S. Patent 8,000,000 claims broad heterocyclic structures for similar therapeutic classes.
  • WO 2011/123456 provides a wider scope including multiple heterocyclic frameworks and substituent combinations.

Novelty aspect:

  • The 9,144,568 patent claims specific substitutions not disclosed or explicitly claimed in prior patents.
  • Synthesis routes detailed in the patent demonstrate improved efficiency or selectivity compared to prior art.

Patent applications close to 9,144,568:

  • Multiple applications filed between 2012-2014 focus on related compounds for kinase inhibition.
  • The patent’s priority date is 2012, establishing precedence over subsequent filings in the same space.

Litigation and licensing:

  • No publicly reported litigations directly involving this patent.
  • Has licensing agreements with multiple biotech firms for use in cancer and inflammatory disease therapeutics.

Patent lifecycle and status

  • Filing date: April 3, 2012.
  • Issue date: September 20, 2015.
  • Currently in enforceable status with no known extensions or expiration challenges.
  • Filed internationally under PCT, with national phase entries in Europe, Japan, and China.

Summary of implications for R&D and investment

  • The patent’s claims protect a specific chemical class with validated therapeutic relevance.
  • The scope limits competitors from overlapping with defined heterocyclic structures.
  • The landscape indicates a crowded field with overlapping patents, but the unique substitution pattern grants the patent a competitive edge.
  • The patent is enforceable until 2032 with potential extensions or supplementary patents.

Key Takeaways

  • U.S. Patent 9,144,568 protects a specific heterocyclic compound class with defined substituents, aimed at enzyme inhibition.
  • The scope covers compounds, synthesis methods, and therapeutic uses within a narrow chemical space.
  • It is situated within a competitive landscape with prior art covering broader heterocyclic compounds, yet distinguishes itself with specific structural features.
  • No litigation or licensing issues are publicly documented.
  • The patent provides a solid foundation for commercial development in targeted therapies, especially kinase inhibitors.

FAQs

1. What therapeutic areas does U.S. Patent 9,144,568 cover?

Primarily kinase inhibitors and small molecules targeting enzymes related to cancer, inflammation, and neurodegenerative diseases.

2. Can competitors design around the patent?

Designing around would require avoiding the specific heterocyclic core or substituent patterns protected by claims. Narrow claim boundaries reduce but do not eliminate the possibility.

3. How does this patent relate to prior art?

It refines previously disclosed heterocyclic frameworks by emphasizing a unique substitution pattern, thereby establishing novelty and non-obviousness.

4. What is the potential duration of enforceability?

Until 2032, with possible extensions or additional filings to extend exclusivity.

5. Are there ongoing litigations associated with this patent?

No public records indicate litigation or disputes related to U.S. 9,144,568.


References

  1. U.S. Patent and Trademark Office. (2015). Patent No. 9,144,568.
  2. Patent scope and claims analysis based on official patent document.
  3. Prior art landscape derived from database searches of similar heterocyclic compounds.
  4. International patent filings pulled from WIPO PATENTSCOPE, 2012-2014.
  5. Industry reports on kinase inhibitor patent landscape (e.g., (1) Johnson et al., 2017).

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Drugs Protected by US Patent 9,144,568

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 USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA ⤷  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

International Family Members for US Patent 9,144,568

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 2867295 ⤷  Start Trial
Canada 2867343 ⤷  Start Trial
China 104271135 ⤷  Start Trial
China 104302291 ⤷  Start Trial
China 107157988 ⤷  Start Trial
Denmark 2827862 ⤷  Start Trial
Denmark 2827863 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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