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Last Updated: July 13, 2020

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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 two NDAs. It is available from two suppliers. There are twenty-four 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. Two 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:13
Formulation / Manufacturing:see details
Generic Entry Opportunity 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 Cardinal Health 55154-6777 55154-6777-8 360 TABLET in 1 BOTTLE, PLASTIC (55154-6777-8)
XIFAXAN rifaximin TABLET;ORAL 021361 NDA Salix Pharmaceuticals, Inc. 65649-301 65649-301-03 30 TABLET in 1 BOTTLE (65649-301-03)
Paragraph IV (Patent) Challenges for 021361
Tradename Dosage Ingredient NDA Submissiondate
XIFAXAN TABLET;ORAL rifaximin 021361 2019-01-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:May 25, 2004TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jun 19, 2024Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Jun 19, 2024Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Jun 19, 2024Product Flag?YSubstance Flag?YDelist Request?

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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.