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Serving 500+ biopharmaceutical companies globally:

Baxter
Citi
US Department of Justice
Accenture
Harvard Business School
Mallinckrodt
Cipla
Deloitte
US Army
Argus Health

Generated: August 17, 2017

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Rifaximin - Generic Drug Details

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What are the generic drug sources for rifaximin and what is the scope of rifaximin patent protection?

Rifaximin
is the generic ingredient in one branded drug marketed by Salix Pharms and is included in two NDAs. There are twenty-six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Rifaximin has two hundred and fifteen patent family members in thirty-six countries.

There are eleven drug master file entries for rifaximin. Six suppliers are listed for this compound.

Summary for Generic Name: rifaximin

Tradenames:1
Patents:26
Applicants:1
NDAs:2
Drug Master File Entries: see list11
Suppliers / Packagers: see list6
Bulk Api Vendors: see list56
Clinical Trials: see list106
Patent Applications: see list2,438
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:rifaximin at DailyMed

Pharmacology for Ingredient: rifaximin

Ingredient-typeRifamycins
Drug ClassRifamycin Antibacterial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Salix Pharms
XIFAXAN
rifaximin
TABLET;ORAL022554-001Mar 24, 2010RXYesYes► Subscribe► SubscribeYY ► Subscribe
Salix Pharms
XIFAXAN
rifaximin
TABLET;ORAL022554-001Mar 24, 2010RXYesYes► Subscribe► SubscribeY ► Subscribe
Salix Pharms
XIFAXAN
rifaximin
TABLET;ORAL022554-001Mar 24, 2010RXYesYes► Subscribe► Subscribe ► Subscribe
Salix Pharms
XIFAXAN
rifaximin
TABLET;ORAL021361-001May 25, 2004RXYesYes► Subscribe► SubscribeY ► Subscribe
Salix Pharms
XIFAXAN
rifaximin
TABLET;ORAL022554-001Mar 24, 2010RXYesYes► Subscribe► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: rifaximin

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
7,056,686Method of diagnosing fibromyalgia caused by small intestinal bacterial overgrowth► Subscribe
7,244,412Methods for manipulating upper gastrointestinal transit, blood flow, and satiety, and for treating visceral hyperalgesia► Subscribe
5,977,175 Methods and compositions for improving digestion and absorption in the small intestine► Subscribe
7,923,553Processes for the production of polymorphic forms of rifaximin► Subscribe
8,388,935Methods of diagnosing and treating small intestinal bacterial overgrowth (SIBO) and SIBO-related conditions► 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 Ingredient: rifaximin

Country Document Number Estimated Expiration
European Patent Office2442803► Subscribe
European Patent Office1676847► Subscribe
European Patent Office2475392► Subscribe
South Korea100883216► Subscribe
Hong Kong1092151► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Citi
Merck
Colorcon
Moodys
Harvard Business School
US Department of Justice
Federal Trade Commission
Queensland Health
Baxter
Dow

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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