Rifaximin - Generic Drug Details

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What are the generic sources for rifaximin and what is the scope of freedom to operate?

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

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

There are fourteen drug master file entries for rifaximin. Three suppliers are listed for this compound.

Summary for rifaximin

International Patents:	206
US Patents:	27
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	162
Patent Applications:	6,710
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for rifaximin
What excipients (inactive ingredients) are in rifaximin?	rifaximin excipients list
DailyMed Link:	rifaximin at DailyMed

Recent Clinical Trials for rifaximin

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Minnesota	Phase 2/Phase 3
Wake Forest University Health Sciences	Phase 2/Phase 3
Emory University	Phase 2/Phase 3

See all rifaximin clinical trials

Pharmacology for rifaximin

Drug Class	Rifamycin Antibacterial

Paragraph IV (Patent) Challenges for RIFAXIMIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XIFAXAN	Tablets	rifaximin	200 mg	021361	1	2019-01-28
XIFAXAN	Tablets	rifaximin	550 mg	021361	1	2015-12-18

US Patents and Regulatory Information for rifaximin

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Glossary

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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	021361-001	May 25, 2004		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for rifaximin

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Country	Patent Number	Title	Estimated Expiration
China	102548408	Methods of treating hepatic encephalopathy	See Plans and Pricing
Russian Federation	2540513	СПОСОБЫ ЛЕЧЕНИЯ ПЕЧЕНОЧНОЙ ЭНЦЕФАЛОПАТИИ (METHOD OF TREATING HEPATIC ENCEPHALOPATHY)	See Plans and Pricing
Poland	2252148		See Plans and Pricing
Hong Kong	1096396	NEW POLYMORPHOUS FORMS OF RIFAXIMIN, PROCESSES FOR THEIR PRODUCTION AND USE THEREOF IN THE MEDICINAL PREPARATIONS	See Plans and Pricing
Japan	2011046738	POLYMORPHS OF RIFAXIMIN, METHODS FOR PRODUCTION THEREOF, AND USE THEREOF IN PHARMACEUTICAL PREPARATION	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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