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Rifaximin - Generic Drug Details
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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 two NDAs. There are twenty-seven 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 five patent family members in thirty-nine countries.
There are fourteen drug master file entries for rifaximin. Two suppliers are listed for this compound.
Summary for rifaximin
International Patents: | 205 |
US Patents: | 27 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Drug Master File Entries: | 14 |
Suppliers / Packagers: | 2 |
Bulk Api Vendors: | 49 |
Clinical Trials: | 146 |
Patent Applications: | 4,876 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for rifaximin |
DailyMed Link: | rifaximin at DailyMed |
Recent Clinical Trials for rifaximin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Bayhealth Medical Center | Phase 4 |
Cedars-Sinai Medical Center | Phase 1/Phase 2 |
Bausch Health Americas, Inc. | Phase 1 |
Pharmacology for rifaximin
Drug Class | Rifamycin Antibacterial |
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 | 022554-001 | Mar 24, 2010 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-001 | May 25, 2004 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-001 | May 25, 2004 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 022554-001 | Mar 24, 2010 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-001 | May 25, 2004 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 022554-001 | Mar 24, 2010 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-001 | May 25, 2004 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for rifaximin
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 |
International Patents for rifaximin
Country | Patent Number | Estimated Expiration |
---|---|---|
Serbia | 20070364 | Start Trial |
Slovenia | 1676847 | Start Trial |
Russian Federation | 2012114600 | Start Trial |
Portugal | 2252148 | Start Trial |
Moldova, Republic of | 4081 | Start Trial |
Cyprus | 1108909 | Start Trial |
Hong Kong | 1092151 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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