Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Farmers Insurance
Teva
QuintilesIMS
Daiichi Sankyo
Argus Health
US Army
Harvard Business School
Healthtrust

Generated: July 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022554

« Back to Dashboard

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
Generic Entry Opportunity Date for 022554
Generic Entry Date for 022554*:
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: 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.

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Daiichi Sankyo
Merck
Deloitte
Mallinckrodt
Citi
Cipla
Queensland Health
Healthtrust

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 verifification 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.