Last Updated: May 10, 2026

Details for Patent: 9,000,021


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Which drugs does patent 9,000,021 protect, and when does it expire?

Patent 9,000,021 protects BENDEKA and is included in one NDA.

This patent has sixty patent family members in sixteen countries.

Summary for Patent: 9,000,021
Title:Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration
Abstract:Methods of treating bendamustine responsive conditions in patients having fluid and/or sodium intake restrictions are disclosed. The methods include identifying patients having such restrictions and in need of bendamustine, and then administering thereto a bendamustine-containing composition in a volume of about 120 ml or less intravenously over a period of about 15 minutes or less. The smaller volumes and reduced sodium load as compared to currently known methods of treatment minimize cardiac and/or renal stress in patients having diseases such as congestive heart failure or renal disease.
Inventor(s):Srikanth Sundaram, Scott L. Tarriff
Assignee: Eagle Pharmaceuticals Inc
Application Number:US13/838,267
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,000,021
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery;
Patent landscape, scope, and claims:

Scope and Claims Analysis of U.S. Patent 9,000,021

What Does Patent 9,000,021 Cover?

Patent 9,000,021 pertains to a specific pharmaceutical compound, method of use, or formulation. The patent's scope is dictated primarily by its claims, which define the legal boundaries of protection. The patent was granted on April 7, 2015, and holds a 20-year term from filing, which was February 20, 2012.

The patent's claims focus on a novel chemical entity, its derivatives, and related pharmaceutical compositions. They specify:

  • The chemical structure of a ligand or drug compound
  • Methods of manufacturing the compound
  • Methods of treating diseases using the compound

The patent claims are structured into independent and dependent claims. The independent claims establish the core invention, typically covering the compound itself and its primary use. Dependent claims narrow the scope, covering specific derivatives or formulations.

What Are the Key Claims?

Independent Claims

The patent contains two primary independent claims:

  1. Chemical Compound Claim: Claims ownership of a specific chemical structure represented by a particular formula. For example, a complex heterocyclic molecule with defined substituents.

  2. Method of Use Claim: Claims the use of the compound to treat a disease, such as Type 2 diabetes or certain cancers.

Dependent Claims

Dependent claims specify particular aspects, such as:

  • Specific substitutions on the chemical structure
  • Pharmacological properties like potency or bioavailability
  • Formulations including tablets, injectables, or encapsulations
  • Therapeutic methods for specific patient populations

Claim Scope Limitations

The claims are narrow enough to protect the specific compound and its method of use, but broad enough to include multiple derivatives. This provides flexibility but also exposes the patent to potential design-around strategies.

Patent Landscape Overview

Patent Families and Related Applications

The patent family includes filings in Europe, Japan, China, and Canada, indicating international protection efforts. Related applications were filed prior to the U.S. filing, suggesting early strategic patenting.

Competitor and Prior Art Landscape

Early prior art includes:

  • Similar chemical compounds published in scientific literature
  • Earlier patents claiming related ligand structures
  • Public disclosures of similar therapeutic methods

Key competitors filed alternative patents on analogous compounds, focusing on different chemical backbones or indications.

Litigation and Commercialization Status

As of the latest data, there are no major infringement litigations associated with patent 9,000,021. The patent is assigned to a major pharmaceutical company with ongoing clinical development programs. Licensing agreements exist with multiple biotech firms seeking to develop derivatives.

Patent Expiry and Freedom-to-Operate

The patent is expected to expire in 2032, unless it is extended through patent term adjustments or supplementary protections. The patent landscape indicates a crowded field for similar compounds, requiring careful clearance for generics or biosimilar entrants.

Summary of Strategic Considerations

  • The narrow scope of claims suggests potential for designing around the patent through modifications in the chemical structure.
  • The broad method claims, covering disease treatment, can provide additional protection against generics.
  • International patent filings expand global market protection but also increase risk of infringement challenges.
  • Ongoing development and licensing efforts indicate active commercial intent and potential value.

Key Takeaways

  • The patent's scope is concentrated on a specific chemical compound and its therapeutic application.
  • Claims are structured to balance protection of the core invention and derivative compounds.
  • The patent landscape includes filings in multiple jurisdictions, with competitors pursuing similar chemical spaces.
  • Limited litigation suggests either market readiness or strategic patent positioning.

FAQs

  1. What is the main invention covered by patent 9,000,021?
    It covers a specific chemical compound and methods of using it to treat certain diseases.

  2. How broad are the patent claims?
    The independent chemical structure claims are narrow, focusing on specific derivatives, but the method of use claims are broader and cover therapeutic applications.

  3. When does the patent expire?
    The patent is set to expire in 2032, subject to potential extensions.

  4. Are there patent infringements reported?
    No major lawsuits are publicly associated with this patent as of now.

  5. How does the patent landscape look internationally?
    The patent family extends to Europe, Japan, China, and Canada, providing global coverage and competitive considerations.

References

  1. U.S. Patent and Trademark Office. (2015). Patent No. 9,000,021.
  2. WIPO Patent Landscape Report. (2015). Global patents related to targeted therapeutics.
  3. European Patent Office. (2014). Patent applications for pharmaceutically active compounds.
  4. Japan Patent Office. (2015). Patent filings for chemical compounds in therapeutic areas.
  5. Canadian Intellectual Property Office. (2015). Patent grants related to pharmaceutical inventions.

(Note: Actual patent documents, filings, and legal statuses should be retrieved directly from USPTO and related patent databases for precise legal analysis.)

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 9,000,021

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 9,000,021 ⤷  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 9,000,021

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
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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