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Generated: June 25, 2017
What are the generic drug sources for rifaximin and what is the scope of rifaximin patent protection?
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 one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 1 |
| Patents: | 27 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: see list | 11 |
| Suppliers / Packagers: see list | 6 |
| Bulk Api Vendors: see list | 56 |
| Clinical Trials: see list | 106 |
| Patent Applications: see list | 2,438 |
| Therapeutic Class: | Antibacterials |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | rifaximin at DailyMed |
| Ingredient-type | Rifamycins |
| Drug Class | Rifamycin Antibacterial |
| 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 | 8,853,231 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 022554-001 | Mar 24, 2010 | RX | Yes | Yes | 7,935,799 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-001 | May 25, 2004 | RX | Yes | Yes | 8,518,949 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 022554-001 | Mar 24, 2010 | RX | Yes | Yes | 7,605,240 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 022554-001 | Mar 24, 2010 | RX | Yes | Yes | ► Subscribe | ► Subscribe | |||||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9,566,270 | Methods for treating irritable bowel syndrome (IBS) | ► Subscribe | |||||||||||||||||||||||||||
| 9,358,276 | Methods of diagnosing and treating small intestinal bacterial overgrowth (SIBO) and SIBO-related conditions | ► Subscribe | |||||||||||||||||||||||||||
| 7,923,553 | Processes for the production of polymorphic forms of rifaximin | ► Subscribe | |||||||||||||||||||||||||||
| 8,110,177 | Methods of diagnosing and treating small intestinal bacterial overgrowth (SIBO) and SIBO-related conditions | ► Subscribe | |||||||||||||||||||||||||||
| 7,081,239 | Methods for manipulating upper gastrointestinal transit, blood flow, and satiety, and for treating visceral hyperalgesia | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| China | 101959412 | ► Subscribe | |||||||||||||||||||||||||||
| Brazil | PI0407149 | ► Subscribe | |||||||||||||||||||||||||||
| New Zealand | 597080 | ► Subscribe | |||||||||||||||||||||||||||
| Portugal | 1557421 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 20030025915 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
Export unavailable in trial.
Subscribe for complete access.
Serving 500+ biopharmaceutical companies globally:
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 verifification 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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