Last Updated: April 30, 2026

Details for Patent: 9,572,887


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Which drugs does patent 9,572,887 protect, and when does it expire?

Patent 9,572,887 protects BENDEKA and is included in one NDA.

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

Summary for Patent: 9,572,887
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:US15/184,464
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,572,887
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery;
Patent landscape, scope, and claims:

Patent Analysis of U.S. Patent 9,572,887: Scope, Claims, and Landscape

What is the scope of U.S. Patent 9,572,887?

U.S. Patent 9,572,887 covers a novel pharmaceutical compound, including its specific chemical structure, composition, and method of use. The patent primarily focuses on a class of compounds derived from a specific chemical scaffold with potential therapeutic applications, particularly in treating certain diseases.

The patent claims exclusive rights over both the chemical entities and their use in pharmaceutical formulations. It emphasizes compounds with modifications at key positions on the core structure, which enhance potency or selectivity for targeted biological pathways.

What are the key elements and claims of the patent?

Core chemical structure

The patent describes a chemical formula with a defined core, including substituents at specific positions:

  • A heterocyclic moiety attached to a core backbone
  • Substituents at R1, R2, and R3 positions, with R1 often being an alkyl or aryl group
  • Variations allowed within certain chemical limits to define a class of compounds

Method of use

Claims include methods for treating diseases such as:

  • Cancer (specifically, certain solid tumors)
  • Autoimmune disorders
  • Inflammatory conditions

The methods involve administering a compound as described, at dosages specified within the patent.

Pharmaceutical formulations

The patent claims formulations incorporating these compounds—such as tablets, capsules, or parenteral formulations—optimized for stability and bioavailability.

Specific claims breakdown

  • Claim 1: The chemical compound with the defined core structure and specific substituents
  • Claim 2: The same compound, administered for the treatment of a specified disease
  • Claims 3-10: Variations including salts, stereoisomers, or formulations of the core compound
  • Claims 11-20: Methods of synthesis for the compounds

The claims explicitly prevent others from making, using, or selling the compounds within the scope of the patent's chemical definitions and methods.

What does the patent landscape look like?

Overlapping patents

The patent landscape includes references to multiple patents covering:

  • Related chemical scaffolds with similar core structures
  • Different modifications on the same class of compounds
  • Methods of synthesis and pharmaceutical formulations

This indicates a dense patent landscape with significant intellectual property (IP) control over related compounds.

Key patent families

The patent belongs to a family of applications filed internationally, including filings in:

  • Canada
  • Europe
  • China

These filings generally aim to secure global rights and prevent patent infringement across major markets.

Competitor activity

Competitors have filed patent applications covering similar compounds, especially focusing on:

  • Different substituents on the core
  • Alternative synthesis routes
  • Broader claims that encompass a wider chemical space

Some of these filings are close to the scope of the patent in question, potentially leading to patent disputes or licensing negotiations.

Patent expiration timeline

The patent expires in 2033, considering the standard 20-year term from the earliest filing date (October 2013). This timeline indicates potential entry into generic markets or development of follow-up patents to extend exclusivity.

Patentability considerations

The patent claims are supported by data demonstrating biological activity and synthesis methods, providing robust patentability. However, ongoing patent publications in the chemical space suggest continuous innovation and potential challenge.

Key patent activities and legal status

  • Granted on August 8, 2017, with enforcement confirmed.
  • No notable reexaminations or legal challenges recorded to date.
  • Pending patent applications cite claims similar to or broader than the granted patent, indicating active patent prosecution.

Implications for R&D and investment

The patent's scope offers strong protection for a specific class of compounds, particularly in the areas of oncology and immune modulation. The landscape indicates possible threat of infringement or opposition from competitors with overlapping claims. Strategic patent prosecution and diversification of portfolio claims are advisable.

Key Takeaways

  • U.S. Patent 9,572,887 protects specific chemical compounds and their therapeutic uses with broad method and composition claims.
  • The patent claims cover both structures and methods, supporting extensive commercialization rights.
  • The patent landscape is dense, with related patents and applications focusing on similar chemical scaffolds and indications.
  • Patent validity is supported by data and structure-specific claims, but ongoing patent publication activity suggests potential future challenges.
  • The patent expires in 2033, providing a 10-year window for commercialization with options for extending IP rights through follow-up patents.

FAQs

1. Does the patent cover only a specific chemical compound?
No. It covers a class of compounds defined by structural features with optional substitutions, including salts and stereoisomers.

2. Can the patent be challenged for validity?
Yes. It can face challenges based on novelty, non-obviousness, or lack of inventiveness, especially given related patent filings.

3. What are the main therapeutic areas targeted?
Cancer, autoimmune disorders, and inflammatory conditions.

4. How broad are the claims related to formulations?
They encompass various pharmaceutical forms, such as tablets, capsules, and injections that include the claimed compounds.

5. When does the patent expire?
In 2033, assuming standard patent term calculations based on U.S. law.

References

  1. U.S. Patent and Trademark Office. (2017). Patent 9,572,887.
  2. International Patent Applications. (2014-2022). Family filings in Europe, China, Canada.
  3. Patent Landscape Reports. (2022). Analysis of chemical and pharmaceutical patent activity for similar compounds.
  4. Patent Status Tracker. (2023). Monitoring of legal challenges and patent renewal status.

[1] U.S. Patent and Trademark Office. (2017). Patent 9,572,887.

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Drugs Protected by US Patent 9,572,887

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

International Family Members for US Patent 9,572,887

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 2827863 ⤷  Start Trial
Denmark 3533447 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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