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Generated: May 24, 2018

DrugPatentWatch Database Preview

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 six suppliers. There are twenty-six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the XIFAXAN profile page.

The generic ingredient in XIFAXAN is rifaximin. There are thirteen 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 021361
Tradename:XIFAXAN
Applicant:Salix Pharms
Ingredient:rifaximin
Patents:13
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 021361
Ingredient-typeRifamycins
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 Physicians Total Care, Inc. 54868-5972 E 54868-5972-0
XIFAXAN rifaximin TABLET;ORAL 021361 NDA Physicians Total Care, Inc. 54868-5972 E 54868-5972-1

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
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Moodys
Boehringer Ingelheim
AstraZeneca
Daiichi Sankyo
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