Rifaximin - Generic Drug Details

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What are the generic drug 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 two NDAs. 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 fifty patent family members in thirty-seven countries.

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

Summary for rifaximin

International Patents:	250
US Patents:	29
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	14
Suppliers / Packagers:	2
Bulk Api Vendors:	76
Clinical Trials:	138
Patent Applications:	3,563
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for rifaximin
DailyMed Link:	rifaximin at DailyMed

Recent Clinical Trials for rifaximin

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Second Affiliated Hospital, School of Medicine, Zhejiang University	Phase 4
The Leukemia and Lymphoma Society	Phase 1
Ospedali Riuniti di Foggia	Phase 3

See all rifaximin clinical trials

Recent Litigation for rifaximin

Identify potential future generic entrants

District Court Litigation

Case Name	Date
SALIX PHARMACEUTICALS, LTD. v. SANDOZ INC.	2019-09-30
Salix Pharmaceuticals, Ltd. v. Actavis Laboratories FL, Inc.	2016-03-23

See all rifaximin litigation

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

Paragraph IV (Patent) Challenges for RIFAXIMIN

Tradename	Dosage	Ingredient	NDA	Submissiondate
XIFAXAN	TABLET;ORAL	rifaximin	021361	2019-01-28
XIFAXAN	TABLET;ORAL	rifaximin	022554	2015-12-18

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	Start Trial	Start Trial				Start Trial
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	022554-001	Mar 24, 2010		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004		RX	Yes	Yes	Start Trial	Start Trial	Y	Y		Start Trial
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	022554-001	Mar 24, 2010		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004		RX	Yes	Yes	Start Trial	Start Trial		Y		Start Trial
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004		RX	Yes	Yes	Start Trial	Start Trial		Y		Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for rifaximin

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

International Patents for rifaximin

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Country	Patent Number	Estimated Expiration
Japan	2016029075	Start Trial
China	101260115	Start Trial
World Intellectual Property Organization (WIPO)	2011032085	Start Trial
Japan	2014177500	Start Trial
European Patent Office	2437603	Start Trial
Canada	2922728	Start Trial
>Country	>Patent Number	>Estimated Expiration

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