Details for New Drug Application (NDA): 021361
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NDA 021361 describes XIFAXAN, which is a drug marketed by Salix Pharms and is included in one NDA. It is available from three suppliers. There are twenty-nine 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. Three suppliers are listed for this compound. Additional details are available on the rifaximin profile page.
The generic ingredient in XIFAXAN is rifaximin. There are fourteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the rifaximin profile page.
Summary for 021361
| Tradename: | XIFAXAN |
| Applicant: | Salix Pharms |
| Ingredient: | rifaximin |
| Patents: | 29 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 021361
Generic Entry Date for 021361*:
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: 021361
Suppliers and Packaging for NDA: 021361
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XIFAXAN | rifaximin | TABLET;ORAL | 021361 | NDA | A-S Medication Solutions | 50090-2445 | 50090-2445-0 | 9 TABLET in 1 BOTTLE (50090-2445-0) |
| XIFAXAN | rifaximin | TABLET;ORAL | 021361 | NDA | Cardinal Health 107, LLC | 55154-6777 | 55154-6777-8 | 360 TABLET in 1 BOTTLE, PLASTIC (55154-6777-8) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | May 25, 2004 | TE: | RLD: | Yes | |||||
| Patent: | 10,703,763 | Patent Expiration: | Feb 27, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE IN ADULTS | ||||||||
| Patent: | 10,703,763 | Patent Expiration: | Feb 27, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS. | ||||||||
| Patent: | 10,703,763 | Patent Expiration: | Feb 27, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF TRAVELERS' DIARRHEA (TD) CAUSED BY NONINVASIVE STRAINS OF ESCHERIA COLI IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER | ||||||||
Expired US Patents for NDA 021361
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-001 | May 25, 2004 | 8,158,781 | ⤷ Subscribe |
| Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-001 | May 25, 2004 | 7,045,620 | ⤷ Subscribe |
| Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-002 | Mar 24, 2010 | 7,902,206 | ⤷ Subscribe |
| Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-002 | Mar 24, 2010 | 7,045,620 | ⤷ Subscribe |
| Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-001 | May 25, 2004 | 8,853,231 | ⤷ Subscribe |
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