Rifaximin - Generic Drug Details

What are the generic sources for rifaximin and what is the scope of freedom to operate?

Rifaximin is the generic ingredient in one branded drug marketed by Salix Pharms and is included in one NDA. There are twenty-nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Rifaximin has two hundred and sixteen patent family members in forty countries.

There are fourteen drug master file entries for rifaximin. Three suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for rifaximin

International Patents:	216
US Patents:	29
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	172
Patent Applications:	6,767
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for rifaximin
What excipients (inactive ingredients) are in rifaximin?	rifaximin excipients list
DailyMed Link:	rifaximin at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for rifaximin

Dosage:

TABLET;ORAL

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.

Recent Clinical Trials for rifaximin

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Tata Memorial Centre	Phase 2
Al-Azhar University	Phase 2
Xin Zeng	N/A

See all rifaximin clinical trials

Generic filers with tentative approvals for RIFAXIMIN

Applicant	Application No.	Strength	Dosage Form
		550MG	TABLET;ORAL
		550MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for rifaximin

Drug Class

Rifamycin Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for rifaximin

A07AA	Antibiotics
A07A	INTESTINAL ANTIINFECTIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

D06AX	Other antibiotics for topical use
D06A	ANTIBIOTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

Paragraph IV (Patent) Challenges for RIFAXIMIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XIFAXAN	Tablets	rifaximin	200 mg	021361	1	2019-01-28
XIFAXAN	Tablets	rifaximin	550 mg	021361	1	2015-12-18

US Patents and Regulatory Information for rifaximin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004		RX	Yes	Yes			Y	Y
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes			Y
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004		RX	Yes	Yes			Y
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes

Expired US Patents for rifaximin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010

International Patents for rifaximin

Country	Patent Number	Title	Estimated Expiration
Morocco	29345	NOUVELLES FORMES POLYMORPHES DE RIFAXIMINE, LEURS PROCEDES DE PREPARATION ET LEUR UTILISATION EN MEDECINE.
Germany	602004006367	Polymorphe Form von Rifaximin als Antibiotikum
Serbia	54571	POLIMORFNI OBLICI RIFAKSIMINA, POSTUPCI ZA NJEGOVU PROZVODNJU I NJEGOVA UPOTREBA U MEDICINSKIM PREPRATIMA (POLYMORPHOUS FORMS OF RIFAXIMIN, PROCESSES FOR THEIR PRODUCTION AND USE THEREOF IN MEDICINAL PREPARATIONS)
Serbia	54568	POLIMORFNI OBLICI RIFAKSIMINA, POSTUPCI ZA NJEGOVU PROIZVODNJU I NJEGOVA UPOTREBA U MEDICINSKIM PREPARATIMA (POLYMORPHOUS FORMS OF RIFAXIMIN, PROCESSES FOR THEIR PRODUCTION AND USE THEREOF IN MEDICINAL PREPARATIONS)
Canada	2765577	MODULATION DE L'EXPOSITION SYSTEMIQUE A LA RIFAXIMINE (MODULATION OF SYSTEMIC EXPOSURE TO RIFAXIMIN)
Jordan	2470	صورة متعددة الأشكال البلورية من ريفاكسيمين، وعمليات لإنتاجها واستخدامها في المستحضرات الطبية. (Polymorphous forms of Rifaximin, Processes for Their Production and Use Thereof in Medicinal Preparations.)