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Details for Patent: 8,158,644

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Patent 8,158,644 protects XIFAXAN and is included in two NDAs. There has been one Paragraph IV challenge on Xifaxan.

This patent has seventy-eight patent family members in thirty-four countries.

Summary for Patent: 8,158,644

Title:Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Abstract: Crystalline polymorphous forms of rifaximin (INN), referred to as rifaximin .alpha. and rifaximin .beta., and a poorly crystalline form referred to as rifaximin .gamma., 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): Viscomi; Giuseppe Claudio (Bologna, IT), Campana; Manuela (Bologna, IT), Braga; Dario (Bologna, IT), Confortini; Donatella (Bologna, IT), Cannata; Vincenzo (Bologna, IT), Righi; Paolo (Bologna, IT), Rosini; Goffredo (Bologna, IT)
Assignee: Alfa Wassermann, S.p.A. (Bologna, IT)
Application Number:13/041,347
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 14th percentile
Forward Citations: 3rd percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Salix Pharms
XIFAXAN
rifaximin
TABLET;ORAL022554-001Mar 24, 2010RXYes8,158,644► subscribeY
Salix Pharms
XIFAXAN
rifaximin
TABLET;ORAL021361-001May 25, 2004RXYes8,158,644► subscribeY
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Foreign Priority and PCT Information for Patent: 8,158,644

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
ItalyM12003A002144Nov 07, 2003

Non-Orange Book Patents for Patent: 8,158,644

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,045,620Polymorphous forms of rifaximin, processes for their production and use thereof in medicinal preparations► subscribe
8,853,231Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin► subscribe
8,158,781Polymorphic forms .alpha., .beta. and .gamma. of rifaximin► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Patent: 8,158,644

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina043547► subscribe
Argentina081991► subscribe
Argentina081992► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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. thinkBiotech performs no independent verifification 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.

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