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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Teva
Merck
Federal Trade Commission
Moodys
Medtronic
Citi
Accenture
Johnson and Johnson
Colorcon

Generated: January 21, 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 twelve 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 54868-6154-2 10 TABLET in 1 BOTTLE (54868-6154-2)
XIFAXAN rifaximin TABLET;ORAL 022554 NDA Physicians Total Care, Inc. 54868-6154 54868-6154-0 2 TABLET in 1 BOTTLE (54868-6154-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength550MG
Approval Date:Mar 24, 2010TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 24, 2017
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Regulatory Exclusivity Expiration:May 27, 2018
Regulatory Exclusivity Use:TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS
Patent:➤ SubscribePatent 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.

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Serving leading biopharmaceutical companies globally:

Medtronic
Mallinckrodt
Deloitte
UBS
Queensland Health
Chubb
Cerilliant
McKinsey
US Army

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