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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 021361

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NDA 021361 describes XIFAXAN, which is a drug marketed by Salix Pharms and is included in one NDA. It is available from three suppliers. There are twenty-two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the XIFAXAN profile page.

The generic ingredient in XIFAXAN is rifaximin. There are fourteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the rifaximin profile page.

Summary for 021361

Tradename:	XIFAXAN
Applicant:	Salix Pharms
Ingredient:	rifaximin
Patents:	22

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 021361

Generic Entry Date for 021361^: ⤷ Get Started Free* Constraining patent/regulatory exclusivity: 8,193,196 Dosage: TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 021361

Suppliers and Packaging for NDA: 021361

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
XIFAXAN	rifaximin	TABLET;ORAL	021361	NDA	A-S Medication Solutions	50090-2445	50090-2445-0	9 TABLET in 1 BOTTLE (50090-2445-0)
XIFAXAN	rifaximin	TABLET;ORAL	021361	NDA	Cardinal Health 107, LLC	55154-6777	55154-6777-8	360 TABLET in 1 BOTTLE, PLASTIC (55154-6777-8)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	May 25, 2004	TE:		RLD:	Yes
Patent:	10,703,763	Patent Expiration:	Feb 27, 2026	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF TRAVELERS' DIARRHEA (TD) CAUSED BY NONINVASIVE STRAINS OF ESCHERIA COLI IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
Patent:	7,906,542	Patent Expiration:	Jun 1, 2025	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	7,928,115	Patent Expiration:	Jul 24, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING TRAVELERS' DIARRHEA

Expired US Patents for NDA 021361

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010	7,902,206	⤷ Get Started Free
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010	7,915,275	⤷ Get Started Free
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004	8,158,644	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification 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.