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Serving leading biopharmaceutical companies globally:

Cipla
UBS
McKesson
Chubb
Mallinckrodt
US Army
Cantor Fitzgerald
Fish and Richardson
Citi
Queensland Health

Generated: January 20, 2018

DrugPatentWatch Database Preview

Xifaxan Drug Profile

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Which patents cover Xifaxan, and when can generic versions of Xifaxan launch?

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-four patent family members in thirty-six countries.

The generic ingredient in XIFAXAN is rifaximin. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the rifaximin profile page.
Summary for Xifaxan
Drug patent expirations by year for Xifaxan
Pharmacology for Xifaxan
Ingredient-typeRifamycins
Drug ClassRifamycin Antibacterial

US Patents and Regulatory Information for Xifaxan

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;ORAL 022554-001 Mar 24, 2010 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 022554-001 Mar 24, 2010 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 022554-001 Mar 24, 2010 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 022554-001 Mar 24, 2010 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 022554-001 Mar 24, 2010 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 022554-001 Mar 24, 2010 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-001 May 25, 2004 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 022554-001 Mar 24, 2010 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 022554-001 Mar 24, 2010 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 022554-001 Mar 24, 2010 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for XIFAXAN
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 550 mg ➤ Subscribe 12/18/2015

Non-Orange Book US Patents for 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
9,629,829 Methods of treating hepatic encephalopathy ➤ Subscribe
9,566,270 Methods for treating irritable bowel syndrome (IBS) ➤ Subscribe
7,048,906 Methods of diagnosing and treating small intestinal bacterial overgrowth (SIBO) and SIBO-related conditions ➤ Subscribe
7,615,207 Methods for treating irritable bowel syndrome ➤ Subscribe
8,173,801 Processes for the production of polymorphic forms of rifaximin ➤ Subscribe
5,977,175 Methods and compositions for improving digestion and absorption in the small intestine ➤ Subscribe
8,404,704 Use of polymorphic forms of rifaximin for medical preparations ➤ Subscribe
7,244,412 Methods for manipulating upper gastrointestinal transit, blood flow, and satiety, and for treating visceral hyperalgesia ➤ Subscribe
8,388,935 Methods of diagnosing and treating small intestinal bacterial overgrowth (SIBO) and SIBO-related conditions ➤ Subscribe
8,197,805 Methods of treating autoimmune diseases caused by small intestinal bacterial overgrowth ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for Xifaxan

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Serving leading biopharmaceutical companies globally:

Baxter
US Department of Justice
Moodys
Chubb
Queensland Health
McKesson
Mallinckrodt
Daiichi Sankyo
Healthtrust

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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