Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 24, 2019

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 two suppliers. There are twenty-eight patents protecting this drug and two Paragraph IV challenges. Additional details are available on the XIFAXAN profile page.

The generic ingredient in XIFAXAN is rifaximin. There are fourteen drug master file entries for this compound. Two 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:27
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.

Paragraph IV (Patent) Challenges for 022554
Tradename Dosage Ingredient NDA Submissiondate
XIFAXAN TABLET;ORAL rifaximin 022554 2015-12-18

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength550MG
Approval Date:Mar 24, 2010TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Oct 2, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE
Patent:  Start TrialPatent Expiration:Oct 2, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:REDUCTION IN A SUBJECT'S RISK OF EXPERIENCING A BREAKTHROUGH OVERT HEPATIC ENCEPHALOPATHY (HE) EPISODE
Patent:  Start 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.

Expired US Patents for NDA 022554

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 022554-001 Mar 24, 2010   Start Trial   Start Trial
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 022554-001 Mar 24, 2010   Start Trial   Start Trial
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 022554-001 Mar 24, 2010   Start Trial   Start Trial
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 022554-001 Mar 24, 2010   Start Trial   Start Trial
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 022554-001 Mar 24, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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