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Last Updated: December 13, 2025

Details for Patent: 8,883,836


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Which drugs does patent 8,883,836 protect, and when does it expire?

Patent 8,883,836 protects TREANDA and is included in one NDA.

Protection for TREANDA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has seventeen patent family members in eleven countries.

Summary for Patent: 8,883,836
Title:Solid forms of bendamustine hydrochloride
Abstract: Novel solid forms of bendamustine hydrochloride are described, as well as methods of their preparation and use.
Inventor(s): Cooper; Martin Ian (Cambridge, GB), Courvoisier; Laurent D. (Thorndale, PA), Eddleston; Mark (Nottingham, GB), McKean; Robert E. (Chester Springs, PA)
Assignee: Cephalon, Inc. (Frazer, PA)
Application Number:14/200,738
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,883,836
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Process;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,883,836

Introduction

U.S. Patent No. 8,883,836 (“the ‘836 patent”) issued on November 11, 2014, represents a significant intellectual property asset within the pharmaceutical and biotech sectors. This patent pertains to innovative methods, compounds, or formulations that potentially target a specific indication or mechanism of action, subject to its precise claim language. As a comprehensive patent analysis, this review evaluates the scope of the claims, their implications for competitors, and contextualizes the patent within the broader landscape of related patent assets.


Scope of the ‘836 Patent

Claimed Subject Matter

The ‘836 patent’s claims define proprietary rights over specific chemical compounds, methods of synthesis, use cases, or formulations. Typically, such patents encompass:

  • Compound claims: Composition of matter that specify chemical structures, often including various chemical derivatives or salts.
  • Method claims: Processes for synthesizing the claimed compounds.
  • Use claims: Therapeutic or diagnostic indications for administering the compounds.
  • Formulation claims: Specific pharmaceutical formulations, including delivery mechanisms.

While detailed claim language is necessary to delineate its boundaries precisely, in general, the scope of the ‘836 patent is anchored in the specific chemical entities or methods it describes. Its claims likely cover a narrow class of compounds with particular substituents or stereochemistry, or methods of treatment utilizing these compounds.

Key Aspects Influencing Scope

  • Claim breadth: Narrow claims targeting specific molecules confer strong protection but limit the scope. Broader claims encompassing subclasses or Markush groups offer wider coverage but are more susceptible to validity challenges.
  • Dependent claims: These refer back to independent claims, adding further limitations. Their presence clarifies specific embodiments.
  • Functional language: Inclusion of functional limitations (e.g., "effective amount" or "therapeutically active") can impact scope and enforceability.

Analysis of the Claims

Claims Structure Breakdown

A typical patent of this nature might contain:

  • Independent claims: Usually encompass the core invention, like a particular chemical compound or a novel use thereof.
  • Dependent claims: Narrow the scope to specific embodiments, such as specific substituents, pharmaceutical compositions, or treatment protocols.

Interpretation of the Claims

  • Chemical Claims: The patent likely claims a compound with a specific core structure, possibly including substitutions or stereochemistry critical to activity.
  • Method of Use: Claims may specify therapy for particular diseases, such as certain cancers, neurological disorders, or infectious diseases.
  • Manufacturing Claims: May encompass novel synthesis methods facilitating improved yield, purity, or cost-efficiency.

Claim Limitations and Potential Challenges

  • Narrow claims afford defensibility but risk easy circumventing.
  • Broad claims face potential invalidation based on prior art.
  • Incorporation of functional language or Markush groups can complicate infringement and validity analysis.

Patent Landscape Context

Related Patents and Patent Families

The patent landscape surrounding the ‘836 patent likely includes:

  • Parent or related applications: Parent applications may offer broader claims and have priority dates that influence prior art considerations.
  • Patent families: Extended protection across jurisdictions, including filings in Europe, Asia, or other key markets, to secure global coverage.
  • Follow-on patents: Improvements or new formulations built upon the original patent.

Key Players and Competition

  • Originator company: Likely holds primary rights and controls licensing.
  • Innovator’s pipeline: Continuously explores new compounds or methods that may infringe or be distinguished from the ‘836 patent.
  • Third-party challengers: Could include competitors or patent trolls seeking to invalidate or design around the patent.

Legal and Regulatory Environment

  • Patent validity may be challenged in patent office proceedings or courts, especially if prior art is identified that anticipates or renders the claims obvious.
  • Clinical validation and regulatory approval influence enforceability, particularly if the patent claims cover methods of treatment.

Implications for Industry and Innovation

The ‘836 patent’s scope delineates the competitive landscape:

  • Exclusive rights: Provide a period of market exclusivity, incentivizing R&D investments.
  • Design-around opportunities: Competitors may explore alternative compounds or methods outside the patent's claims.
  • Collaborations and licensing: The patent may serve as a strategic asset for partnerships or licensing agreements, especially if it covers novel, high-value indications.

Conclusion

The ‘836 patent’s claims are centered on specific chemical entities, methods of their synthesis, or therapeutic applications. Its scope hinges upon claim breadth, claim language, and how it interfaces with prior art. The patent landscape is dynamic, with potential continuations, related patents, and challenges shaping its strength and reach. For industry stakeholders, understanding its scope facilitates strategic decisions around patentability, infringement, and licensing.


Key Takeaways

  • The ‘836 patent claims are primarily focused on specific chemical compounds or methods relevant to its therapeutic targets.
  • Its strength depends on claim specificity; narrow claims provide targeted protection, while broad claims offer extensive coverage but face higher validity risks.
  • The patent landscape includes related filings, potential extensions, and competitors’ filings, influencing enforcement strategies.
  • Ongoing patent challenges and legal proceedings can impact the patent’s enforceability and market exclusivity.
  • Companies should evaluate their pipeline for potential infringement or design-around options based on the exact claim scope.

FAQs

1. What are the main types of claims in U.S. Patent 8,883,836?

The patent predominantly contains claims related to chemical compounds, methods of synthesis, and therapeutic uses. These encompass independent claims defining core structures and dependent claims adding specific limitations.

2. How broad is the scope of the ‘836 patent’s claims?

The scope depends on claim language; narrow claims focus on specific molecules or methods, while broader claims may cover several chemical subclasses or therapeutic indications. The actual breadth can be assessed by analyzing the detailed claim language.

3. Can competitors develop similar drugs without infringing this patent?

Yes, if they design around the claims by modifying chemical structures or employing different methods that fall outside the patent’s scope, they may avoid infringement.

4. What factors influence the validity of the ‘836 patent?

Prior art references, obviousness arguments, claim clarity, and the novelty of the invention affect validity. Patent challenges often target these areas, especially if pre-existing similar compounds or methods are identified.

5. How does the patent landscape affect future innovation?

A strong patent provides exclusivity and investment confidence, while a crowded landscape may prompt innovation in alternative compounds or delivery methods beyond the patent’s scope.


Sources

[1] U.S. Patent and Trademark Office. U.S. Patent No. 8,883,836.
[2] Patent Advisory Resources. Patent Landscape Reports.
[3] Global Patent Database. Patent Family and Citation Analysis.
[4] Industry Reports. Pharmaceutical Patent Strategies.
[5] Court Cases and Litigation Records. Patent Validity and Infringement Proceedings.

More… ↓

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Drugs Protected by US Patent 8,883,836

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Cephalon TREANDA bendamustine hydrochloride POWDER;INTRAVENOUS 022249-002 May 1, 2009 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Cephalon TREANDA bendamustine hydrochloride POWDER;INTRAVENOUS 022249-001 Mar 20, 2008 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  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

International Family Members for US Patent 8,883,836

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 072777 ⤷  Get Started Free
Canada 2718939 ⤷  Get Started Free
Chile 2009000742 ⤷  Get Started Free
China 101980698 ⤷  Get Started Free
China 103550159 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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