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XIFAXAN Drug Profile

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Which patents cover Xifaxan, and what substitute generic drugs are available?

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

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

Summary for Tradename: XIFAXAN

Patents:25
Applicants:1
NDAs:2
Suppliers / Packagers: see list6
Bulk Api Vendors: see list26
Clinical Trials: see list22
Patent Applications: see list1,418
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:XIFAXAN at DailyMed

Pharmacology for Tradename: XIFAXAN

Ingredient-typeRifamycins
Drug ClassRifamycin Antibacterial
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Salix Pharms
XIFAXAN
rifaximin
TABLET;ORAL021361-001May 25, 2004RXYesYes9,271,968► SubscribeY ► Subscribe
Salix Pharms
XIFAXAN
rifaximin
TABLET;ORAL022554-001Mar 24, 2010RXYesYes7,045,620► SubscribeY ► Subscribe
Salix Pharms
XIFAXAN
rifaximin
TABLET;ORAL021361-001May 25, 2004RXYesYes7,902,206► SubscribeYY ► Subscribe
Salix Pharms
XIFAXAN
rifaximin
TABLET;ORAL021361-001May 25, 2004RXYesYes8,158,781► SubscribeY ► Subscribe
Salix Pharms
XIFAXAN
rifaximin
TABLET;ORAL022554-001Mar 24, 2010RXYesYes9,271,968► SubscribeY ► Subscribe
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Paragraph IV activity 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
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
8,404,704Use of polymorphic forms of rifaximin for medical preparations► Subscribe
8,173,801Processes for the production of polymorphic forms of rifaximin► Subscribe
8,562,952Methods for manipulating satiety► 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
Canada2594789► Subscribe
Canada2404889► Subscribe
South Korea100612050► Subscribe
Germany04005541► Subscribe
Argentina081991► 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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