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Boehringer Ingelheim
Daiichi Sankyo
Mallinckrodt
Johnson and Johnson
Medtronic
Baxter
AstraZeneca
Chubb
Federal Trade Commission

Generated: December 18, 2018

DrugPatentWatch Database Preview

XIFAXAN Drug Profile

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Which patents cover Xifaxan, and what generic alternatives are available?

Xifaxan is a drug marketed by Salix Pharms and is included in two NDAs. There are twenty-six patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in XIFAXAN is rifaximin. There are thirteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the rifaximin profile page.

Drug patent expirations by year for XIFAXAN
Generic Entry Opportunity Date for XIFAXAN
Generic Entry Dates for XIFAXAN*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL
Generic Entry Dates for XIFAXAN*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for XIFAXAN
Synonyms for XIFAXAN
(2S,16Z,18E,20S,21S,22R,23R,24R,25S,26R,27S,28E)-25-(Acetyloxy)-5,6,21,23-tetrahydroxy-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)-dio
(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
(7S,9E,11S,12R,13S,14R,15R,16R,17S,18S,19E,21Z)-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,
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
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
Bio-0556
BRD-K89708791-001-01-8
BRN 3584528
BSPBio_003545
C43H51N3O11
CAS-80621-81-4
CCG-101048
CCG-221129
CCG-39867
CHEBI:75246
CHEMBL1467058
CHEMBL1617
CPD000466324
CS-0862
D02554
D04ITO
DB01220
DR003561
DSSTox_CID_25998
DSSTox_GSID_45998
DSSTox_RID_81280
DTXSID7045998
EBD46661
Fatroximin
Flonorm
H732
HMS2051D18
HMS2093B17
HMS2232N07
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
Normix
NSC-758957
NSC758957
NZCRJKRKKOLAOJ-XRCRFVBUSA-N
Pharmakon1600-01505321
Q-201671
R0101
RCIFAX
RedActiv
refaximin
Rifacol
Rifacol;Fatroximin;Xifaxan
Rifamixin
Rifamycin L 105
Rifamycin L 105SV
Rifaxidin
Rifaximin
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
SAM001246597
SAM002589928
SBI-0206751.P001
SCHEMBL124066
SCHEMBL124067
SCHEMBL16229249
SMR000466324
SPECTRUM1505321
Spiraxin
Tox21_111529
UNII-L36O5T016N
W-5133
Xifaxan (TN)
Xifaxan, Xifaxanta
Xifaxsan
ZINC169311798
ZINC169621200
ZINC169675595
ZINC253387917

US Patents and Regulatory Information for XIFAXAN

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 ➤ 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 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 021361-001 May 25, 2004 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
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for XIFAXAN
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 550 mg ➤ Subscribe ➤ Sign Up

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Daiichi Sankyo
Mallinckrodt
Johnson and Johnson
Medtronic
Baxter
AstraZeneca
Chubb
Federal Trade Commission

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.