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 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 six patent family members in thirty-nine 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: | 206 |
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for rifaximin
Generic Entry Dates for rifaximin*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
Generic Entry Dates for rifaximin*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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 |
Kalinga 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 |
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 | ⤷ 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 | 021361-001 | May 25, 2004 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-001 | May 25, 2004 | 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 | 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 | ⤷ 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 |
---|---|---|---|
South Korea | 100885755 | ⤷ Try a Trial | |
Morocco | 27069 | FORMES POLYMORPHES DE RIFAXIMIN, PROCEDES POUR LEUR PRODUCTION ET USAGE DE MeME DANS LES PREPARATIONS MEDICINALES | ⤷ Try a Trial |
Russian Federation | 2582940 | СПОСОБЫ ЛЕЧЕНИЯ СИНДРОМА РАЗДРАЖЕННОГО КИШЕЧНИКА (СРК) (METHODS FOR TREATING IRRITABLE BOWEL SYNDROME (IBS)) | ⤷ Try a Trial |
Austria | E361927 | ⤷ Try a Trial | |
Denmark | 2350096 | ⤷ Try a Trial | |
Portugal | 2252148 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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