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Last Updated: March 28, 2024

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-nine 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:29
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 021361
Generic Entry Date for 021361*:
Constraining patent/regulatory exclusivity:
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:RXDosage:TABLET;ORALStrength200MG
Approval Date:May 25, 2004TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Feb 27, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE IN ADULTS
Patent:⤷  Try a TrialPatent Expiration:Feb 27, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS.
Patent:⤷  Try a TrialPatent Expiration:Feb 27, 2026Product 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

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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 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.