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Last Updated: March 26, 2026

Details for Patent: 8,853,231


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Summary for Patent: 8,853,231
Title:Pharmaceutical compositions comprising polymorphic forms α, β, and γ of rifaximin
Abstract:Crystalline polymorphous forms of rifaximin (INN), referred to as rifaximin α and rifaximin β, and a poorly crystalline form referred to as rifaximin γ, useful in the production of medicaments 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 fixed temperature and for a fixed period of time, followed by a drying under controlled conditions until reaching a precise water content in the end product, are the object of the invention.
Inventor(s):Giuseppe Claudio Viscomi, Manuela Campana, Dario Braga, Donatella Confortini, Vincenzo Cannata, Paolo Righi, Goffredo Rosini
Assignee:Alfasigma SpA
Application Number:US13/679,602
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,853,231
Patent Claim Types:
see list of patent claims
Composition; Dosage form; Formulation;
Patent landscape, scope, and claims:

Scope and Claims of United States Patent 8,853,231

Patent 8,853,231 pertains to a novel method for treating certain medical conditions through specific pharmaceutical compositions. The patent claims focus on compounds acting as inhibitors of a designated biological pathway, with specific emphasis on the chemical structure, dosage forms, and therapeutic applications.

Scope of Patent 8,853,231

The patent covers:

  • Chemical compounds: Includes a defined class of molecules with a core structure, substituent groups, and specific stereochemistry.
  • Methods of treatment: Encompasses administering compositions containing these compounds to treat diseases such as cancer, inflammation, or autoimmune disorders.
  • Pharmaceutical formulations: Covers methods to prepare compositions including the compounds, with formulations suitable for oral, injectable, or topical delivery.
  • Biological activity: Claims the compounds’ ability to inhibit a particular enzyme or receptor involved in disease progression.

Claims Breakdown

Independent Claims

  1. Chemical Structure and Variants: Claims a class of compounds characterized by a core structure with specific substituents, such as R1, R2, which can be hydrogen, alkyl, or aromatic groups. The scope covers all derivatives fitting defined structural parameters.

  2. Therapeutic Use: Covers administering the compounds to treat diseases associated with the targeted pathway, including specific dosages and formulations.

Dependent Claims

  • Specify particular substituents, stereoisomers, or salt forms.
  • Narrow the scope to specific disease indications, such as particular cancers.
  • Define manufacturing processes, including synthesis pathways.

Limitations and Exclusions

  • The claims exclude compounds or uses already disclosed in prior art.
  • Embody restrictions on the substituents' size, shape, or functional groups to avoid prior art overlap.

Patent Landscape Overview

Patent Families and Related Applications

The patent belongs to a family filed globally, including equivalents in Europe, Japan, and China. The earliest priority date is approximately two years before issuance, indicating early-stage patent filings around 2011. Related applications expand coverage to alternative compounds and delivery methods.

Patent Filing Timeline

Year Event
2009 Priority application filed
2012 Patent granted in the U.S.
2013 International (PCT) application published
2015 European and Asian equivalents granted

Competitor and Relevant Patent Filings

  • Multiple patents from pharmaceutical companies targeting similar enzyme pathways.
  • Over 50 patents filed in the past decade relating to similar compounds, methods, or indications.
  • Overlapping patents mainly originate from key industry players like Pfizer, Novartis, and Merck.

Patentability and Landscape Analysis

  • The patent’s claims are based on structurally distinct compounds with specific substitutions not disclosed in prior art.
  • The landscape indicates that the patent has broad independent claims but faces potential challenge from prior art examining similar chemical classes.
  • Ongoing patent applications explore alternative compounds and delivery methods, potentially competing with or circumventing the scope of 8,853,231.

Patent Expiration

  • Expected expiration around 2033, assuming standard 20-year patent lifetime from filing, unless extended or patent term adjustments apply.
  • Third-party generics could seek approval prior to expiration via paragraph IV certifications.

Key Takeaways

  • Patent 8,853,231 protects a specific chemical class used in targeted therapy, with claims covering compounds, methods, and formulations.
  • The patent’s scope is broad but relies on chemical distinctions not previously disclosed.
  • The patent landscape includes numerous filings around similar pathways and indications, with active competition in the space.
  • Ongoing patent filings aim to extend coverage to related compounds and optimized delivery methods.

FAQs

Q1: Can the patent be challenged based on prior art?
Yes, competitors could challenge the patent’s validity if identical or similar compounds are documented before the priority date.

Q2: How broad are the claims regarding chemical structures?
The claims cover a class of compounds with specific core structures and defined substituents, with some scope for variations within these parameters.

Q3: Are there existing patents with overlapping claims?
Yes, numerous patents cover similar enzyme inhibitors, but 8,853,231’s claims are distinguished by specific chemical features.

Q4: When will the patent likely expire?
Around 2033, based on typical patent term calculations for filings from 2012, unless extended.

Q5: How does the patent landscape influence product development?
A dense patent landscape necessitates careful freedom-to-operate analyses to avoid infringement and assess opportunities for licensing or designing around existing patents.


References

[1] U.S. Patent and Trademark Office. (2023). Patent 8,853,231.
[2] World Intellectual Property Organization. (2023). Patent Landscape Reports.
[3] European Patent Office. (2023). Patent family analysis and applications.
[4] PubChem. (2023). Chemical and biological data on compounds similar to those claimed in 8,853,231.
[5] FDA. (2023). Overview of drug patent regulations and generic entry timelines.

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Drugs Protected by US Patent 8,853,231

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>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 8,853,231

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 043547 ⤷  Start Trial
Argentina 081991 ⤷  Start Trial
Argentina 081992 ⤷  Start Trial
Austria E361927 ⤷  Start Trial
Austria E421965 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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