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Rifaximin - Generic Drug Details

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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:	65
Clinical Trials:	107
Patent Applications:	2,897
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for rifaximin
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

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			Y	Y
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	022554-001	Mar 24, 2010		RX	Yes	Yes			Y	Y
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	022554-001	Mar 24, 2010		RX	Yes	Yes			Y
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	022554-001	Mar 24, 2010		RX	Yes	Yes

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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.

Patent No.	Title	Estimated Patent Expiration
9,629,829	Methods of treating hepatic encephalopathy
9,855,254	Methods of treating hepatic encephalopathy
7,923,553	Processes for the production of polymorphic forms of rifaximin
8,173,801	Processes for the production of polymorphic forms of rifaximin

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International Patents for rifaximin

Country	Document Number	Estimated Expiration
Japan	2012504649
Germany	04005541
European Patent Office	1676847
Morocco	29345