RIFAXIMIN - Generic Drug Details
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What are the generic 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 eleven 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: | 211 |
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: | 169 |
Patent Applications: | 6,767 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Xin Zeng | N/A |
Sun Yat-sen University | Early Phase 1 |
All India Institute of Medical Sciences, Bhubaneswar | Phase 1 |
Generic filers with tentative approvals for RIFAXIMIN
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 550MG | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 200MG | 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 | 021361-001 | May 25, 2004 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-002 | Mar 24, 2010 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-002 | Mar 24, 2010 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-002 | Mar 24, 2010 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-002 | Mar 24, 2010 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-001 | May 25, 2004 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for RIFAXIMIN
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Austria | 421966 | ⤷ Try a Trial | |
Serbia | 20150292 | 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) | ⤷ Try a Trial |
Poland | 2350096 | ⤷ Try a Trial | |
Denmark | 1676847 | ⤷ Try a Trial | |
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) | ⤷ Try a Trial |
China | 101260115 | Polymorphous forms of rifaximin, preparation and application thereof used in pharmaceutical preparation | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
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