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Serving leading biopharmaceutical companies globally:

Fuji
Dow
Chubb
Fish and Richardson
AstraZeneca
UBS
Merck
QuintilesIMS
Cerilliant
Covington

Generated: December 14, 2017

DrugPatentWatch Database Preview

XIFAXAN Drug Profile

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Which patents cover Xifaxan, and what generic alternatives are available?

Xifaxan is a drug marketed by Salix Pharms and is included in two NDAs. There are twenty-six patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and thirty-five patent family members in thirty-six countries.

The generic ingredient in XIFAXAN is rifaximin. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the rifaximin profile page.
Drug patent expirations by year for XIFAXAN

Pharmacology for XIFAXAN

Ingredient-typeRifamycins
Drug ClassRifamycin Antibacterial

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Salix PharmsXIFAXANrifaximinTABLET;ORAL022554-001Mar 24, 2010RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Salix PharmsXIFAXANrifaximinTABLET;ORAL022554-001Mar 24, 2010RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Salix PharmsXIFAXANrifaximinTABLET;ORAL022554-001Mar 24, 2010RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Salix PharmsXIFAXANrifaximinTABLET;ORAL022554-001Mar 24, 2010RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Salix PharmsXIFAXANrifaximinTABLET;ORAL022554-001Mar 24, 2010RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Salix PharmsXIFAXANrifaximinTABLET;ORAL022554-001Mar 24, 2010RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Salix PharmsXIFAXANrifaximinTABLET;ORAL021361-001May 25, 2004RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Salix PharmsXIFAXANrifaximinTABLET;ORAL022554-001Mar 24, 2010RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Salix PharmsXIFAXANrifaximinTABLET;ORAL022554-001Mar 24, 2010RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Salix PharmsXIFAXANrifaximinTABLET;ORAL022554-001Mar 24, 2010RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for XIFAXAN

Drugname Dosage Strength RLD Submissiondate
rifaximinTablets550 mgXifaxan12/18/2015

Non-Orange Book Patents for Tradename: XIFAXAN

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
8,173,801Processes for the production of polymorphic forms of rifaximin► Subscribe
9,358,276Methods of diagnosing and treating small intestinal bacterial overgrowth (SIBO) and SIBO-related conditions► Subscribe
7,081,239Methods for manipulating upper gastrointestinal transit, blood flow, and satiety, and for treating visceral hyperalgesia► Subscribe
8,388,935Methods of diagnosing and treating small intestinal bacterial overgrowth (SIBO) and SIBO-related conditions► Subscribe
7,736,622Methods of diagnosing small intestinal bacterial overgrowth (SIBO) and SIBO-related conditions► Subscribe
5,977,175 Methods and compositions for improving digestion and absorption in the small intestine► Subscribe
7,244,412Methods for manipulating upper gastrointestinal transit, blood flow, and satiety, and for treating visceral hyperalgesia► Subscribe
9,566,270Methods for treating irritable bowel syndrome (IBS)► Subscribe
7,923,553Processes for the production of polymorphic forms of rifaximin► Subscribe
8,110,177Methods 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 Tradename: XIFAXAN

Country Document Number Estimated Expiration
Israel184694► Subscribe
Japan2015166381► Subscribe
Australia5862996► Subscribe
World Intellectual Property Organization (WIPO)2009108814► Subscribe
China102625701► Subscribe
Israel160798► Subscribe
Serbia54568► Subscribe
World Intellectual Property Organization (WIPO)2006094662► Subscribe
Australia2004200964► Subscribe
Australia2004287601► 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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Serving leading biopharmaceutical companies globally:

Fuji
Daiichi Sankyo
McKinsey
Johnson and Johnson
US Army
Novartis
Harvard Business School
Queensland Health
Teva
Medtronic

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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