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Last Updated: October 22, 2019

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-eight patents protecting this drug and two Paragraph IV challenges.

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

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

Drug patent expirations by year for XIFAXAN
Drug Prices for XIFAXAN

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Drug Sales Revenue Trends for XIFAXAN

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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.

Recent Clinical Trials for XIFAXAN

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

SponsorPhase
The Leukemia and Lymphoma SocietyPhase 1
Emory UniversityPhase 1
Commonwealth Diagnostics International, Inc.Phase 4

See all XIFAXAN clinical trials

Recent Litigation for XIFAXAN

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 XIFAXAN litigation

Pharmacology for XIFAXAN
Synonyms for XIFAXAN
(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
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
BRN 3584528
C43H51N3O11
CAS-80621-81-4
CCG-221129
CHEBI:75246
CHEMBL1617
D02554
DB01220
DSSTox_CID_25998
DSSTox_GSID_45998
DSSTox_RID_81280
DTXSID7045998
Fatroximin
Flonorm
H732
HMS3715B19
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
RedActiv
Rifacol
Rifacol;Fatroximin;Xifaxan
Rifamixin
Rifamycin L 105
Rifamycin L 105SV
Rifaxidin
Rifaximin
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
SCHEMBL124066
Spiraxin
Tox21_111529
UNII-L36O5T016N
Xifaxan (TN)
Xifaxsan
ZINC169621200

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   Start Trial   Start Trial   Start Trial
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   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 XIFAXAN

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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for XIFAXAN
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 200 mg ➤ Subscribe   Start Trial
➤ Subscribe Tablets 550 mg ➤ Subscribe   Start Trial

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Serving leading biopharmaceutical companies globally:

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Dow

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