Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Medtronic
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McKinsey
Express Scripts
Colorcon

Last Updated: December 6, 2019

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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 freedom to operate?

Rifaximin is the generic ingredient in one branded drug marketed by Salix Pharms and is included in two NDAs. There are twenty-eight 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-six patent family members in thirty-seven countries.

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

Recent Clinical Trials for rifaximin

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

SponsorPhase
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 4
The Leukemia and Lymphoma SocietyPhase 1
Leiden University Medical CenterPhase 4

See all rifaximin clinical trials

Recent Litigation for rifaximin

Identify potential future generic entrants

District Court Litigation
Case NameDate
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
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

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 Y   Start Trial
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 022554-001 Mar 24, 2010 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 Y 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

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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Baxter
Mallinckrodt
Moodys
Medtronic
AstraZeneca

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