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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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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