Rifaximin - Generic Drug Details
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What are the generic drug sources for rifaximin and what is the scope of patent protection?
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 |
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 |
Generic filers with tentative approvals for RIFAXIMIN
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 550MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 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
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 | 021361-002 | Mar 24, 2010 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-002 | Mar 24, 2010 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-002 | Mar 24, 2010 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-002 | Mar 24, 2010 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-001 | May 25, 2004 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-001 | May 25, 2004 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>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 | 021361-002 | Mar 24, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-001 | May 25, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-001 | May 25, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-002 | Mar 24, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-002 | Mar 24, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-001 | May 25, 2004 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for rifaximin
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2011046738 | POLYMORPHS OF RIFAXIMIN, METHODS FOR PRODUCTION THEREOF, AND USE THEREOF IN PHARMACEUTICAL PREPARATION | ⤷ Sign Up |
Slovenia | 3628319 | ⤷ Sign Up | |
Hong Kong | 1092150 | POLYMORPHOUS FORMS OF RIFAXIMIN AS ANTIBIOTICS | ⤷ Sign Up |
South Korea | 20050043589 | POLYMORPHOUS FORMS OF RIFAXIMIN, PROCESSES FOR THEIR PRODUCTION AND USE THEREOF IN MEDICINAL PREPARATIONS | ⤷ Sign Up |
Slovenia | 2350096 | ⤷ Sign Up | |
Canada | 2594789 | NOUVELLES FORMES POLYMORPHES DE RIFAXIMINE, LEURS PROCEDES DE PREPARATION ET LEUR UTILISATION EN MEDECINE (NEW POLYMORPHOUS FORMS OF RIFAXIMIN, PROCESSES FOR THEIR PRODUCTION AND USE THEREOF IN THE MEDICINAL) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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