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Rifaximin - Generic Drug Details

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-six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Rifaximin has two hundred and thirty-six patent family members in thirty-six countries.

There are thirteen drug master file entries for rifaximin. Six suppliers are listed for this compound.

Summary for rifaximin

International Patents:	236
US Patents:	26
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	13
Suppliers / Packagers:	6
Bulk Api Vendors:	34
Clinical Trials:	107
Patent Applications:	2,897
Formulation / Manufacturing:	see details
Drug Prices:	see low prices
DailyMed Link:	rifaximin at DailyMed

Pharmacology for rifaximin

Ingredient-type	Rifamycins
Drug Class	Rifamycin Antibacterial

Synonyms for rifaximin

(2S,16Z,18E,20S,21S,22R,23R,24R,25S,26R,27S,28E)-5,6,21,23-tetrahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-1,15-dioxo-1,2-dihydro-2,7-(epoxypentadeca[1,11,13]trienoimino)furo[2'',3'':7',8']naphtho[1',2':4,5]imidazo[1
(2S,16Z,18E,20S,21S,22R,23R,24R,25S,26R,27S,28E)5,6,21,23-Tetrahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-1,15-dioxo-1,2-dihydro-2,7-(epoxypentadeca[1,11,13]trienoimino)[1]benzofuro[4,5-e]pyr
(2S,16Z,18E,20S,21S,22R,23R,24R,25S,26S,27S,28E)-5,6,21,23,25 Pentahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-2,7-(epoxypentadeca(1,11,13)trienimino)benzofuro(4,5-e)pyrido(1,2-a)benzimidazole-1,15(2H)-dione, 25-aceta
(7S,11S,12R,13S,14R,15R,16R,17S,18S)-2,15,17,36-tetrahydroxy-11-methoxy-3,7,12,14,16,18,22,30-octamethyl-6,23-dioxo-8,37-dioxa-24,27,33-triazahexacyclo[23.10.1.1;{4,7}.0;{5,35}.0;{26,34}.0;{27,32}]heptatriaconta-1,3,5(35),9,1
2,7-(Epoxypentadeca(1,11,13)trienimino)benzofuro(4,5-e)pyrido(1,2-a)benzimidazole-1,15(2H)-dione, 25-(acetyloxy)-5,6,21,23-tetrahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-, (2S-(2R,16Z,18E,20R,21R,22S,23S,24S,2
4-Deoxy-4'-methylpyrido(1',2'-1,2)imidazo(5,4-c)rifamycin SV
4-deoxy-4'-methylpyrido(1',2'-1,2)imidazo(5,4C)rifamycin
4-Deoxy-4'-methylpyrido[1',2'-1,2]imidazo[5,4-c]rifamycin SV
621R814
80621-81-4
88747-56-2
AB01209738_04
AB01209738-01
AB01209738-03
AB2000295
AC-19112
AKOS015963053
alpha-0817185
AN-36430
BC208535
BDBM50347620
Bio-0556
BRN 3584528
C43H51N3O11
CAS-80621-81-4
CCG-221129
CHEBI:75246
CHEMBL1617
D02554
D04ITO
DB01220
DSSTox_CID_25998
DSSTox_GSID_45998
DSSTox_RID_81280
DTXSID7045998
Fatroximin
Flonorm
H732
ido[1,2-a]benzimidazol-25-yl acetate
J10371
L 105
L 105 (Ansamacrolide antibiotic)
L 105SV
L36O5T016N
Lormyx
LS-178059
LS-64147
Lumenax
MFCD00864973
NCGC00095842-01
Normix
NZCRJKRKKOLAOJ-XRCRFVBUSA-N
Q-201671
RCIFAX
RedActiv
refaximin
Rifacol
Rifacol;Fatroximin;Xifaxan
Rifamixin
Rifamycin L 105
Rifamycin L 105SV
Rifaxidin
Rifaximin (bioadhesive/ gastrointestinal extended release)
Rifaximin (bioadhesive/ gastrointestinal extended release), Salix Pharmaceuticals
Rifaximin (JAN/USAN/INN)
Rifaximin (Xifaxan)
Rifaximin [USAN:INN:BAN]
Rifaximin [USAN:INN]
Rifaximin, Antibiotic for Culture Media Use Only
Rifaximina
Rifaximina [Spanish]
Rifaximine
Rifaximine [French]
Rifaximinum
Rifaximinum [Latin]
rifaximinun
Rifaxin
Ritacol
s1790
SCHEMBL124066
Spiraxin
Tox21_111529
UNII-L36O5T016N
Xifaxan
Xifaxan (TN)
Xifaxsan
ZINC169621200

US Patents and Regulatory Information for rifaximin

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Glossary

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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	➤ Sign Up	➤ Sign Up	Y	Y		➤ Sign Up
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	022554-001	Mar 24, 2010		RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	022554-001	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
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

Non-Orange Book US Patents for rifaximin

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.

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Patent No.	Title	Estimated Patent Expiration
6,805,852	Methods of diagnosing irritable bowel syndrome and other disorders caused by small intestinal bacterial overgrowth	➤ Sign Up
7,736,622	Methods of diagnosing small intestinal bacterial overgrowth (SIBO) and SIBO-related conditions	➤ Sign Up
8,110,177	Methods of diagnosing and treating small intestinal bacterial overgrowth (SIBO) and SIBO-related conditions	➤ Sign Up
7,923,553	Processes for the production of polymorphic forms of rifaximin	➤ Sign Up
Patent No.	Title	Estimated Patent Expiration

International Patents for rifaximin

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Country	Document Number	Estimated Expiration
Australia	2010271070	➤ Sign Up
European Patent Office	2261664	➤ Sign Up
European Patent Office	2475392	➤ Sign Up
Mexico	2011003548	➤ Sign Up
Country	Document Number	Estimated Expiration