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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Cantor Fitzgerald
Fish and Richardson
Chinese Patent Office
McKinsey
McKesson
Healthtrust
Cipla
Medtronic

Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022554

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NDA 022554 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 022554
Tradename:XIFAXAN
Applicant:Salix Pharms
Ingredient:rifaximin
Patents:25
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 022554
Ingredient-typeRifamycins
Suppliers and Packaging for NDA: 022554
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XIFAXAN rifaximin TABLET;ORAL 022554 NDA Physicians Total Care, Inc. 54868-6154 E 54868-6154-0
XIFAXAN rifaximin TABLET;ORAL 022554 NDA Physicians Total Care, Inc. 54868-6154 E 54868-6154-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength550MG
Approval Date:Mar 24, 2010TE:RLD:Yes
Regulatory Exclusivity Expiration:May 27, 2018
Regulatory Exclusivity Use:TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS
Patent:➤ Try a Free TrialPatent Expiration:Aug 11, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS AND SYMPTOMS THEREOF.
Patent:➤ Try a Free TrialPatent Expiration:Aug 11, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS.

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Johnson and Johnson
Cantor Fitzgerald
Argus Health
US Army
Deloitte
Cipla
Chubb
Harvard Business School

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