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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-seven 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 forty-two patent family members in thirty-six countries.

There are fourteen drug master file entries for rifaximin. Five suppliers are listed for this compound.

Summary for rifaximin

International Patents:	242
US Patents:	27
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	14
Suppliers / Packagers:	5
Bulk Api Vendors:	75
Clinical Trials:	131
Patent Applications:	3,133
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

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)[1]benzofuro[4,5-e]pyr

2S-Acetyloxy-5,6,21,23-tetrahydroxy-27-methoxy-2,4,11, 16,20,22,24,26-octamethyl-2,7-(epoxypentoeleca(1,11,13)trienimino)benzofuro[4,5-e]pyride[1,2-a]benzimidazole-1,15(2H)-dione

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

AB01563059_01

AB2000295

AC-19112

AKOS015963053

AKOS025142098

AKOS026750043

alpha-0817185

AN-36430

AS-13252

BC208535

BDBM50347620

BRD-K89708791-001-01-8

BRD-K92838188-001-01-9

BRN 3584528

BSPBio_003545

C43H51N3O11

CAS-80621-81-4

CCG-101048

CCG-221129

CCG-39867

CHEBI:75246

CHEMBL1467058

CHEMBL1617

CPD000466324

CS-0862

D02554

DB01220

DSSTox_CID_25998

DSSTox_GSID_45998

DSSTox_RID_81280

DTXSID7045998

EBD46661

Fatroximin

Flonorm

H732

HMS2051D18

HMS2093B17

HMS2232N07

HMS3715B19

HY-13234

I06-0036

ido[1,2-a]benzimidazol-25-yl acetate

J10371

KS-00000H17

L 105

L 105 (Ansamacrolide antibiotic)

L 105SV

L36O5T016N

Lormyx

LS-178059

LS-64147

Lumenax

MCULE-1303528930

MCULE-6354658075

MFCD00864973

MLS000759430

MLS001424186

MLS003882589

MolPort-006-822-652

NC00298

NCGC00095842-01

NCGC00271415-03

Normix

NSC-758957

NSC758957

NZCRJKRKKOLAOJ-XRCRFVBUSA-N

Pharmakon1600-01505321

Q-201671

R0101

RedActiv

Rifacol

Rifacol;Fatroximin;Xifaxan

Rifamixin

Rifamycin L 105

Rifamycin L 105SV

Rifaxidin

Rifaximin (JAN/USAN/INN)

Rifaximin (Xifaxan)

Rifaximin [USAN:INN:BAN]

Rifaximin [USAN:INN]

Rifaximin, 98%

Rifaximin, Antibiotic for Culture Media Use Only

Rifaximina

Rifaximina [Spanish]

Rifaximine

Rifaximine [French]

Rifaximinum

Rifaximinum [Latin]

rifaximinun

Rifaxin

Ritacol

s1790

SAM001246597

SAM002589928

SBI-0206751.P001

SCHEMBL124066

SCHEMBL124067

SCHEMBL16229249

SMR000466324

SPECTRUM1505321

Spiraxin

SR-01000759340

SR-01000759340-4

SR-05000001803

SR-05000001803-1

SW219076-1

Tox21_111529

UNII-L36O5T016N

W-5133

Xifaxan

Xifaxan (TN)

Xifaxan, Xifaxanta

Xifaxsan

ZINC169311798

ZINC169621200

ZINC169675595

ZINC253387917

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
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	022554-001	Mar 24, 2010		RX	Yes	Yes
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	022554-001	Mar 24, 2010		RX	Yes	Yes			Y
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004		RX	Yes	Yes			Y
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
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	022554-001	Mar 24, 2010		RX	Yes	Yes			Y	Y

Expired US Patents for rifaximin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	022554-001	Mar 24, 2010
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	022554-001	Mar 24, 2010
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	022554-001	Mar 24, 2010
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	022554-001	Mar 24, 2010
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	022554-001	Mar 24, 2010

International Patents for rifaximin

Country	Patent Number	Estimated Expiration
Croatia	P20070433
Mexico	2011012829
Brazil	PI0402382
Australia	2010271070
European Patent Office	2261665
Austria	421966
Austria	514946