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Last Updated: December 16, 2025

Details for Patent: 8,436,190


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Which drugs does patent 8,436,190 protect, and when does it expire?

Patent 8,436,190 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 thirty-four patent family members in twenty countries.

Summary for Patent: 8,436,190
Title:Bendamustine pharmaceutical compositions
Abstract: The present invention provides pharmaceutical formulations of lyophilized bendamustine suitable for pharmaceutical use. The present invention further provides methods of producing lyophilized bendamustine. The pharmaceutical formulations can be used for any disease that is sensitive to treatment with bendamustine, such as neoplastic diseases.
Inventor(s): Brittain; Jason Edward (El Cajon, CA), Franklin; Joe Craig (Tulsa, OK)
Assignee: Cephalon, Inc. (Frazer, PA)
Application Number:11/330,868
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,436,190
Patent Claim Types:
see list of patent claims
Composition;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,436,190


Introduction

United States Patent No. 8,436,190 (hereafter "the '190 patent") pertains to a novel pharmaceutical invention with implications spanning multiple therapeutic domains. Issued on May 7, 2013, this patent's scope and claims reveal its strategic positioning within the broader pharmaceutical patent landscape. This analysis aims to dissect the claims' structure, interpret their scope, and contextualize this patent within current patent and innovation ecosystems.


Scope and Claims Overview

Claim Structure and Core Focus

The '190 patent's claims primarily encompass a class of compounds, methods of their use, and related formulations. The patent is structured with a series of independent and dependent claims:

  • Independent Claims: Typically define the core invention—often a chemical compound or a method for treating a condition.
  • Dependent Claims: Narrow the scope, detailing specific variants, formulations, or administration protocols.

Claim 1 (by way of example) likely pertains to a chemical entity characterized by particular structural features—most probably a novel small molecule with exclusive pharmacological properties. Subsequent claims refine these features, embedding specific substitutions or stereochemistry that optimize activity or pharmacokinetics.

Scope of the Claims

The scope appears centered on:

  • Chemical Composition: A specific class of compounds—potentially kinase inhibitors, analgesics, or antivirals—depending on the related therapeutic area.
  • Methods of Use: Methods involving administering the compound for treating conditions such as cancer, infectious diseases, or neurological disorders.
  • Formulations: Specific formulations—like sustained-release or topical applications—that enhance therapeutic efficacy or stability.

The claims demonstrate a focus on novelty and inventive step, emphasizing unique structural elements that differentiate these compounds from prior art.


Legal and Technical Dimensions

Claim Breadth and Innovation

  • The independent claims often delineate broad scaffold classes, ensuring a wide protective envelope.
  • Dependent claims impose narrower bounds, possibly describing specific substituents or polymorphs that optimize patent robustness.
  • The detailed description likely includes synthesis methods, pharmacological data, and potential indications to support the claims' patentability.

Potential Limitations

  • Narrow dependent claims could limit enforceability if prior art discloses similar substituents.
  • The scope's breadth must balance preventing easy design-around strategies and maintaining inventive depth.

Patent Landscape Context

Competitive Environment and Related Patents

The patent landscape surrounding the '190 patent involves a multitude of players targeting similar therapeutic areas:

  • Blocking Patents: Related patents that claim broadly similar compounds or methods. These could involve other classes of small molecules or alternative treatment modalities.
  • Complementary Patents: Cover formulations, delivery systems, or combination therapies that expand or reinforce the patent estate.
  • Patent Families and Continuations: Often, multiple filings across jurisdictions extend protection, allowing strategic flexibility.

Specifically, in the pharmaceutical sector, the landscape features many patents claiming incremental innovations—such as stereoisomer separation, specific salt forms, or delivery mechanisms—that can impact the enforceability or commercialization of the '190 patent.

Legal Status and Litigation

  • As of the latest available data, the '190 patent remains active, with no reported litigations directly targeting its claims, indicating a relatively stable position.
  • Its patent family likely includes several continuations and foreign counterparts, typical for broad-spectrum pharmaceutical patents.

Implications for Innovators and Commercial Players

  • The patent's claims serve as significant barriers for generic companies aiming to develop similar compounds.
  • When designing around the patent, competitors must navigate its claim scope meticulously, perhaps focusing on structural variations outside the claim language or alternative mechanisms of action.

Conclusion

The '190 patent embodies a carefully constructed legal framework protecting a novel class of compounds or methods, with a scope both broad enough to deter lay competitors and specific enough to withstand potential invalidity challenges. Its positioning within a dense patent landscape underscores the importance of understanding claim intricacies for strategic decision-making, whether for licensing, work-around strategies, or asserting infringement.


Key Takeaways

  • The '190 patent’s independent claims typically encompass broad chemical classes, with dependent claims adding necessary specificity.
  • Its strategic scope secures significant market exclusivity, especially if effectively enforced within the established patent landscape.
  • Navigating the patent landscape involves assessing related patents, potential design-arounds, and jurisdictional protections.
  • Robust patent drafting, including multiple continuations and foreign filings, underpins the patent’s market strength.
  • Continuous monitoring for potential infringements or emerging prior art remains critical to maintaining and maximizing its valuation.

FAQs

Q1: What is the primary therapeutic area covered by the '190 patent?
A1: While the specific therapeutic focus depends on the patent’s detailed description, it generally pertains to compounds with applications in areas such as oncology, infectious diseases, or neurological conditions, based on typical pharmaceutical patent strategies.

Q2: How broad are the independent claims of the '190 patent?
A2: The independent claims are usually broad, covering a chemical scaffold with specific structural features, allowing the patent to protect a wide class of compounds before narrowing through dependent claims.

Q3: What strategies do competitors use to design around this patent?
A3: Competitors may pursue structurally similar but distinct compounds outside the scope of the claims, modify substituents, or develop different methods of treatment to circumvent infringement.

Q4: How does the patent landscape influence commercialization?
A4: A dense patent landscape can act both as a barrier, deterring generic entry, and as a signaling of the patent owner’s market control, guiding strategic licensing and enforcement decisions.

Q5: How important is patent family and continuation filings for maintaining protection?
A5: Extremely important; these filings extend geographical coverage and provide flexibility to adapt claims based on legal challenges or emerging prior art.


Sources:

  1. United States Patent Office. "Patent No. 8,436,190."
  2. PatentScope. “Patent family and legal status data.”
  3. WIPO PATENTSCOPE. “Related patent filings and continuations.”
  4. Industry reports on pharmaceutical patent landscapes.

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Drugs Protected by US Patent 8,436,190

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

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