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Generated: October 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 five 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. Five 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
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.

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:➤ Sign UpPatent 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:➤ Sign UpPatent 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:

Harvard Business School
Baxter
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Moodys
Colorcon
Queensland Health
Express Scripts
QuintilesIMS

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