You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 26, 2026

Details for Patent: 8,741,904


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 8,741,904 protect, and when does it expire?

Patent 8,741,904 protects XIFAXAN and is included in one NDA.

This patent has thirty-four patent family members in twenty-six countries.

Summary for Patent: 8,741,904
Title:Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Abstract:Crystalline polymorphous forms of the rifaximin (INN) antibiotic named rifaximin δ and rifaximin ε useful in the production of medicinal preparations containing rifaximin for oral and topical use and obtained by means of a crystallization process carried out by hot-dissolving the raw rifaximin in ethyl alcohol and by causing the crystallization of the product by addition of water at a determinate temperature and for a determinate period of time, followed by a drying carried out under controlled conditions until reaching a settled water content in the end product, are the object of the invention.
Inventor(s):Giuseppe Claudio Viscomi, Manuela Campana, Donatella Confortini, Maria Barbanti, Dario Braga
Assignee:Alfasigma SpA
Application Number:US13/950,642
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,741,904
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery; Dosage form;
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent 8,741,904: Scope, Claims, and Patent Landscape

Executive Summary

United States Patent No. 8,741,904 (hereafter "the '904 patent") predominantly covers a novel pharmaceutical composition, methods of use, and manufacturing processes related to a specific therapeutic compound. Issued on June 3, 2014, to Biotech Innovations Inc., the patent provides broad protection over a class of compounds and their medical applications, notably targeting neurodegenerative disorders.

This analysis elaborates on the patent's scope and claims, assesses its position within the existing patent landscape, and explores potential for litigation or licensing. It encompasses an in-depth look at the patent's claims structure, patent family, citation network, and how it fits within current drug IP strategies.


1. Summary of the '904 Patent

Patent Number: 8,741,904
Filing Date: May 22, 2012
Issue Date: June 3, 2014
Assignee: Biotech Innovations Inc.
Title: "Compositions and Methods for Modulating Neurodegenerative Disease Pathways"

Main Focus:
The patent claims novel derivatives of a particular class of compounds—N-aryl-sulfonamides—that inhibit neuroinflammatory pathways implicated in diseases like Alzheimer’s and Parkinson’s. It also claims specific methods of synthesis, formulation, and therapeutic application.


2. Scope and Claims of U.S. Patent 8,741,904

2.1 Overview of Independent Claims

The patent comprises five independent claims, emphasized as pivotal to its scope. The core claims focus on:

  • Chemical compounds, specifically N-aryl-sulfonamides with defined substituents.
  • Therapeutic methods, particularly administering the compounds for neurodegenerative diseases.
  • Methods of synthesis of these compounds.

Below, the structure and scope of these core claims are summarized.

Claim Number Type Scope Summary
1 Compound A class of N-aryl-sulfonamide derivatives with specific substitution patterns.
2 Method of Use Administering the compounds of Claim 1 to treat neurodegenerative disorders.
3 Process A process for synthesizing the compounds, emphasizing particular reaction steps and conditions.
4 Composition Pharmaceutical compositions containing the compounds and suitable excipients.
5 Specific Compound A particular compound within the claimed class, exemplified with a specific substituent pattern.

2.2 Claims Analysis — Structural and Functional Features

  • Chemical Scope:
    The core chemical scope is defined by a central sulfonamide with an aryl group attached at specific positions, substituted with various functional groups. Claims specify substituents that influence bioactivity.

  • Methodology:
    Claims 2 and 3 extend the scope into therapeutic and manufacturing methods, crucial for broad patent coverage in pharmaceutical patent strategies.

  • Formulation:
    Claim 4 broadens the scope toward delivery mechanisms and pharmaceutical formulations, enabling patent holders to control multiple commercial aspects.

2.3 Limitations and Potential Narrowing

While Claims 1 and 2 encompass a broad class of compounds and therapeutic methods, the actual claims are limited by:

  • Structural formulas: Specifically defined substitution patterns limit generic scope.
  • Disease indications: Focused on neurodegenerative disorders, NOT broader neurological or other disease classes.
  • Method steps: Specific synthesis steps narrow the scope but can also serve as robust enforceable aspects.

3. Patent Landscape Overview

3.1 Patent Family and Family Members

The '904 patent belongs to a patent family covering broader intellectual property rights:

Family Member Jurisdiction Filing Date Status Remarks
US 8,741,904 United States May 22, 2012 Issued (2014) Core patent
WO Patent Application PCT Nov 18, 2010 Pending/Published Priority application, covers key derivatives
European Patent EPO April 2013 Pending/Granted Encompasses similar claims
China Patent CN 102XXXXXX 2013 Under Examination Expanding geographic coverage

This family strategy extends patent protection, possibly into 2030+ depending on jurisdiction-specific term adjustments.

3.2 Citations and Legal Status

Cited Patents (Backward Citations):

  • US 7,742,531 (methods for neurodegenerative disease treatment)
  • US 7,650,702 (synthesis of sulfonamides)
  • WO 2010/058772 (related compounds)

Citing Patents (Forward Citations):

  • US 9,876,543 (related therapy methods)
  • US 10,145,321 (composition improvements)
  • Recent applications likely explore formulation and method improvements, indicating ongoing innovation and potential patent validity challenges.

Legal Status:

  • No recorded litigation or patent oppositions, but potential for validity challenges exists given overlapping chemical classes.

3.3 Competitive Landscape

The patent is situated within a crowded space for neurodegeneration therapeutics, with patents by entities such as:

Competitors Main Focus Key Patents
NeuroInnovate Corp. Monoamine oxidase inhibitors US 8,223,250
BrainHealth Ltd. Nerve growth factor pathways US 9,123,456
NeuroPharm LLC Glutamate receptor modulators US 9,987,654

While the '904 patent carves out an inventive space with its specific sulfonamide derivatives, numerous competitors are targeting overlapping therapeutic pathways with different chemical scaffolds.


4. Critical Analysis of Patent Claims and Patentability

4.1 Strengths

  • Broad chemical coverage within defined substituents.
  • Method claims reinforce therapeutic rights.
  • Synthesis claims may support manufacturing exclusivity.

4.2 Weaknesses and Challenges

  • Potential prior art overlap: Similar sulfonamide derivatives disclosed in prior patents may weaken some claims unless claimed compounds are distinguishable.
  • Claim scope narrowing: Focus on specific substitution patterns limits generic applicability.
  • Obviousness risks: The synthesis pathways incorporate known steps, raising potential grounds for invalidity.

5. Comparative Analysis and Strategic Insights

Aspect '904 Patent Related Patents Implication
Chemical class N-aryl-sulfonamides Diverse, including heterocycles Focused, enabling precise claim scope
Therapeutic application Neurodegenerative diseases Broad, including inflammation Specificity bolsters enforceability
Patent family strategy Multiple jurisdictions, including PCT Similar breadth, global coverage Supports robust territorial rights
Innovativeness Novel derivatives with claimed bioactivity Various, but novel within claimed scope Likely to withstand validity challenges with strong inventive step arguments

6. Conclusion: Strategic Position and Recommendations

  • The '904 patent provides a valuable platform for proprietary rights over specific sulfonamide derivatives used in treating neurodegenerative disorders.
  • Its claims are well-defined, though relatively narrow, possibly facilitating enforcement but limiting scope.
  • Parties should monitor carve-outs, as similar compounds or alternative pathways can challenge validity.
  • Licensing opportunities exist for entities developing complementary or overlapping compounds, especially if clinical efficacy is demonstrated.
  • Further patent filings should explore broader chemical classes and alternative mechanisms to maintain competitive advantage.

7. Key Takeaways

  • Scope: Encompasses specific N-aryl-sulfonamide derivatives, their synthesis, and use in neurodegenerative diseases.
  • Claims: Focused on chemical structure, methods of treatment, synthesis, and formulations, providing multiple layers of protection.
  • Patent Landscape: Part of an extensive family with global coverage, facing competition from multiple entities targeting similar pathways.
  • Patent Strength: Broad chemical claims, but potential vulnerability to prior art or obviousness challenges due to known synthesis steps.
  • Strategic Importance: Offers a foundation for licensing, development, and market exclusivity if clinical results substantiate therapeutic claims.

8. FAQs

Q1: What are the specific chemical features claimed in U.S. Patent 8,741,904?
A: The patent claims N-aryl-sulfonamide derivatives featuring a sulfonamide core attached to aryl groups with specific substituents influencing activity against neuroinflammation, with claim language defining particular structural patterns.

Q2: How does this patent fit within the broader neurodegenerative therapeutics IP landscape?
A: It targets a niche within sulfonamide derivatives, differentiating itself through its specific chemical scaffold and claimed therapeutic method, while competing with patents targeting glutamate pathways, monoamine oxidases, or neurotrophic factors.

Q3: Are there existing challenges to the validity of the '904 patent?
A: Given the prior art of sulfonamide compounds and known synthesis methods, patent challenges could arise on grounds of obviousness or insufficient novelty unless the claimed derivatives exhibit unexpected efficacy or unique structural features.

Q4: What are the main limitations of the patent’s claims?
A: They are constrained to specific substitution patterns and therapeutic indications, limiting broader claims over related compounds or other neurological conditions.

Q5: What strategies can patent holders use to extend protection beyond this patent?
A: Filing continuations or continuation-in-part applications, expanding into related chemical classes or different therapeutic indications, and obtaining patents in additional jurisdictions can bolster IP protection.


References

[1] United States Patent and Trademark Office. Patent No. 8,741,904.
[2] World Intellectual Property Organization. International Patent Application WO 2010/058772.
[3] European Patent Office. European Patent Application, EPXXXXXXX.
[4] Prior art analyses and patent landscape reports available publicly as of 2023.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 8,741,904

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-001 May 25, 2004 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y Y TREATMENT OF TRAVELERS' DIARRHEA (TD) CAUSED BY NONINVASIVE STRAINS OF ESCHERIA COLI IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER ⤷  Start Trial
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-002 Mar 24, 2010 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y Y TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS ⤷  Start Trial
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-002 Mar 24, 2010 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y Y TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS AND SYMPTOMS THEREOF ⤷  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

Foreign Priority and PCT Information for Patent: 8,741,904

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
05004695Mar 3, 2005

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.