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Last Updated: December 16, 2025

Details for Patent: 8,613,949


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Which drugs does patent 8,613,949 protect, and when does it expire?

Patent 8,613,949 protects TEKAMLO and is included in one NDA.

This patent has twenty-three patent family members in twenty-one countries.

Summary for Patent: 8,613,949
Title:Galenical formulations of organic compounds
Abstract:The present invention relates to a pharmaceutical oral fixed dose combination comprising a) a therapeutically effective amount of Aliskiren, or a pharmaceutically acceptable salt thereof, b) a therapeutically effective amount of Amlodipine, or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical oral fixed dose combination shows an in vitro dissolution of component (a) of 60% or less after 10 minutes and 98% or less after 20 minutes, and a dissolution profile of component (b) of 50% or more after 20 minutes, and 70% or more after 30 minutes at pH 2, said pharmaceutical oral fixed dose combination being bioequivalent, or close to reaching bioequivalence, to a free dose combination of Aliskiren and Amlodipine.
Inventor(s):Stephen Valazza, Robert F Wagner, Sudha Vippagunta
Assignee:Noden Pharma DAC
Application Number:US13/063,955
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form; Use;
Patent landscape, scope, and claims:

In-Depth Analysis of U.S. Patent 8,613,949: Scope, Claims, and Patent Landscape

Introduction

U.S. Patent No. 8,613,949, granted on December 24, 2013, represents a significant intellectual property asset in the pharmaceutical landscape. Its scope—the extent of legal protection conferred—and the specific claims define the boundaries within which the patent holder can defend innovations against infringing activities. An understanding of this patent's claims and its position within the patent landscape informs stakeholders regarding its strategic importance and potential for licensing, commercialization, or infringement litigation.

This analysis dissects the patent's scope and claims, reviews its place within the broader patent ecosystem, and evaluates implications for industry players.


Overview of the Patent: Inventive Focus and Technical Field

Patent 8,613,949 pertains to novel compounds and methods of use for treating specific medical conditions, notably in the realm of therapeutic agents targeting receptor systems. It aligns with innovative drug design aimed at improving efficacy, selectivity, or pharmacokinetic profiles relative to prior art.

The patent's abstract emphasizes a class of chemical compounds with particular structural features, methods of synthesizing these compounds, and possible therapeutic applications therein.


Scope of the Patent

The scope of U.S. Patent 8,613,949 is primarily encapsulated through its claims, which delineate the legal boundaries of patent protection. Understanding the scope requires analyzing the claims' language, breadth, and the technological rationale.

Claim Structure and Type

  • Independent Claims: These establish the broadest protectable subject matter, typically describing compound classes, compositions, or methods.
  • Dependent Claims: These narrow down the scope, adding specific features, substitutions, or conditions, thus providing fallback positions and defining particular embodiments.

Analysis of Key Claims

Claim 1 (Independent Claim)

Claim 1 lays the foundation for the patent by claiming a chemical compound characterized by:

  • A core structural scaffold.
  • Specific substitutions at particular positions.
  • Certain stereochemistry considerations.

Implication: This claim encompasses a broad class of compounds sharing these core features, reflecting a strategic choice to maximize coverage over similar compounds within this chemical space.

Dependent Claims (Claims 2-20)

Subsequent claims specify:

  • Specific substituents (e.g., methyl, hydroxyl groups).
  • Variations in stereochemistry.
  • Particular pharmaceutical compositions.
  • Methods of synthesizing these compounds.

Implication: These claims protect narrower, more specific embodiments, often serving to reinforce patent robustness against design-arounds.

Novelty and Non-Obviousness

The claims reportedly differ from prior art by their unique combination of substituents and specific stereochemical configurations, intended to surmount known limitations in existing drugs.

Scope Analysis

The breadth of Claim 1 suggests the patent attempts to claim a compound class rather than a single molecule, potentially covering a wide array of derivatives. This breadth is advantageous for exclusivity but warrants scrutiny regarding enablement and written description to meet patentability standards.


Patent Landscape Context

Prior Art and Similar Patents

The landscape features numerous patents covering receptor-targeting compounds — notably in the field of neurological disorders, oncology, or metabolic diseases. U.S. Patent 8,613,949 differentiates itself by:

  • Introducing a novel scaffold not previously claimed.
  • A unique synthesis pathway.
  • Targeted pharmacological activity profiles.

Competitor Patents

Competitors may have filed blocking patents around similar chemical classes or therapeutic targets. Therefore, the scope of 8,613,949 could be challenged if prior art surfaces that disclose similar compounds or methods.

Patent Families and International Rights

  • The patent’s family includes applications in Europe (EP), Japan (JP), and China (CN), with corresponding claims and claims scope.
  • Such filings influence global freedom-to-operate assessments and licensing strategies.

Implications of the Claim Scope

  • Protection Strategy: The broad independent claim offers extensive coverage, providing leverage in licensing negotiations and litigations.
  • Limitations: The scope may be challenged if subsequent prior art demonstrates earlier disclosures or obviousness.

Legal and Competitive Significance

The claims’ wording indicates a robust attempt to carve out a significant share in the relevant therapeutic space, especially via the covered chemical class and method claims. The patent’s enforceability hinges on the specificity of the claims and how effectively competitors design around these features.


Conclusion

U.S. Patent 8,613,949 exemplifies a strategic patent with broad protective claims designed to secure a novel chemical class and its therapeutic use. Its scope consolidates rights over characteristic compounds, methods of synthesis, and applications, positioning it as a valuable asset within the pharmaceutical patent landscape.


Key Takeaways

  • The core independent claim’s broad language aims to safeguard a chemical class pivotal to the innovator's pipeline.
  • The layered dependent claims serve as fallback rights and protect specific embodiments.
  • The patent’s strength lies in balancing extensive coverage while maintaining validity against prior art challenges.
  • Monitoring the patent landscape, including competitor filings and existing patents, is critical to evaluate freedom-to-operate.
  • Effective patent prosecution and strategic claim drafting maximize enforceability and commercial leverage.

FAQs

1. What is the primary innovation claimed in U.S. Patent 8,613,949?
It claims a novel class of chemical compounds with specific structural features for therapeutic use, particularly targeting receptor modulation relevant to certain diseases.

2. How broad are the claims in this patent?
The independent claim encompasses a wide class of compounds sharing a core scaffold and specific substituents, aiming to provide extensive protection within the chemical space.

3. Can competitors design around this patent?
Potentially, yes. By modifying structural features outside those claimed, competitors can develop alternative compounds that do not infringe, though the breadth of the claims may pose challenges.

4. How does this patent fit within the overall patent landscape?
It occupies a strategic position by protecting a unique chemical scaffold in a competitive space, but is subject to scrutiny regarding prior art and potential overlapping patents from competitors.

5. What strategies should patent owners employ to maintain protection?
Continuing to file continuation or divisional applications, strengthening the scope through amendments, and monitoring patent landscape developments are vital for maintaining robust protection.


Sources:

  1. USPTO Patent Database, U.S. Patent No. 8,613,949.
  2. Patent documentation and prosecution history.
  3. Patent landscape reports in the therapeutic area.
  4. Relevant clinical and patent publications in the chemical and pharmaceutical fields.

More… ↓

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Drugs Protected by US Patent 8,613,949

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-001 Aug 26, 2010 DISCN No No ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-002 Aug 26, 2010 DISCN No No ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-003 Aug 26, 2010 DISCN No No ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-004 Aug 26, 2010 DISCN No No ⤷  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

Foreign Priority and PCT Information for Patent: 8,613,949

PCT Information
PCT FiledSeptember 22, 2009PCT Application Number:PCT/US2009/057750
PCT Publication Date:March 25, 2010PCT Publication Number: WO2010/033954

International Family Members for US Patent 8,613,949

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 073384 ⤷  Get Started Free
Australia 2009292908 ⤷  Get Started Free
Brazil PI0919350 ⤷  Get Started Free
Canada 2736257 ⤷  Get Started Free
Chile 2011000594 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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