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Last Updated: December 14, 2019

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Ursodiol - Generic Drug Details

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What are the generic sources for ursodiol and what is the scope of freedom to operate?

Ursodiol is the generic ingredient in four branded drugs marketed by Allergan Sales Llc, Abhai Llc, Amneal Pharms Co, Epic Pharma, Impax Labs Inc, Lannett Co Inc, Mylan, Teva Pharms, Glenmark Generics, Par Pharm, Teva Pharms Usa, and Zydus, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for ursodiol. Twenty-two suppliers are listed for this compound.

Drug Prices for ursodiol

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Drug Sales Revenue Trends for ursodiol

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Recent Clinical Trials for ursodiol

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

SponsorPhase
Ethan WeinbergPhase 2
American Association for the Study of Liver DiseasesPhase 2
Exalenz Bioscience LTD.Phase 2

See all ursodiol clinical trials

Pharmacology for ursodiol
Drug ClassBile Acid
Synonyms for ursodiol
(3a,5b,7b)-3,7-dihydroxy-cholan-24-oate
(3a,5b,7b)-3,7-dihydroxy-cholan-24-oic acid
(3a,5b,7b)-3,7-dihydroxycholan-24-oic acid
(3alpha,5beta,7beta,8xi)-3,7-dihydroxycholan-24-oic acid
(3alpha,5beta,7beta)-3,7-dihydroxycholan-24-oic acid
(4R)-4-[(1S,2S,5R,7S,9S,10R,11S,14R,15R)-5,9-dihydroxy-2,15-dimethyltetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadecan-14-yl]pentanoic acid
(4R)-4-[(1S,2S,5R,7S,9S,10R,11S,14R,15R)-5,9-Dihydroxy-2,15-dimethyltetracyclo[8.7.0.02,1.011,1]heptadecan-14-yl]pentanoic acid
(4R)-4-[(3R,5S,7S,8R,9S,10S,13R,14S,17R)-10,13-dimethyl-3,7-bis(oxidanyl)-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl]pentanoic acid
(4R)-4-[(3R,5S,7S,8R,9S,10S,13R,14S,17R)-3,7-dihydroxy-10,13-dimethyl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl]pentanoic acid
(4R)-4-[(3R,5S,7S,8R,9S,10S,13R,14S,17R)-3,7-dihydroxy-10,13-dimethyl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl]valeric acid
(R)-4-((3R,5S,7S,8R,9S,10S,13R,14S,17R)-3,7-dihydroxy-10,13-dimethylhexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)pentanoic acid
128-13-2
17-beta-(1-Methyl-3-carboxypropyl)etiocholane-3-alpha,7-beta-diol
17.beta.-(1-Methyl-3-carboxypropyl)etiocholane-3.alpha.,7.beta.-diol
3 alpha,7 beta-Dihydroxy-5 beta-cholan-24-oic Acid
3-alpha,7-beta-Dihydroxy-5-beta-cholanoic acid
3-alpha,7-beta-Dihydroxycholanic acid
3-alpha,7-beta-Dioxycholanic acid
3,7-Dihydroxycholan-24-oic acid
3,7-Dihydroxycholan-24-oic acid-, (3.alpha.,5.beta.,7.beta.)- #
3.alpha.,7.beta.-Dihydroxy-5.beta.-cholan-24-oic acid
3.alpha.,7.beta.-Dihydroxy-5.beta.-cholanic acid
3.alpha.,7.beta.-Dihydroxycholanic acid
3A,7A-Dihydroxy-5A-holan-24-oic acid
3a,7b-dihydroxy-5b-cholan-24-oate
3a,7b-dihydroxy-5b-cholan-24-oic acid
3alp.,7bet.-Dihydroxy-5bet.-cholan-24-oic acid
3alpha, 7beta-dihydroxy-5beta-cholanoic acid
3alpha,7 beta-Dihydroxy-5 beta-cholan-24-oic acid
3alpha,7beta-Dihydroxy-5beta-cholan-24-oic acid
3alpha,7beta-Dihydroxy-5beta-cholanic acid
3alpha,7beta-dihydroxycholanic acid
4-10-00-01604 (Beilstein Handbook Reference)
5 beta-Cholan-24-oic acid-3alpha,7 beta-diol
5-beta-Cholan-24-oic acid, 3-alpha,7-beta-dihydroxy-
5.beta.-Cholan-24-oic acid, 3.alpha.,7.beta.-dihydroxy-
50809-41-1
5A-Cholan-24-oic acid-3A,7A-diol
5bet.-Cholan-24-oic acid-3alp.,7bet.-diol
5beta-Cholan-24-oic acid-3alpha,7beta-diol
5beta-Cholanic Acid-3alpha,7beta-diol
7 beta-Hydroxylithocholic acid
7-beta-Hydroxylithocholic acid
7.beta.-Hydroxylithocholic acid
724L30Y2QR
7A-Hydroxylithocholic acid
7bet.-Hydroxylithocholic acid
7beta-Hydroxylithocholic acid
80225-86-1
A-7799
AB00513977
AB00513977_10
AB00513977-09
AB2000188
AC-18919
AC1L1LJH
Acide ursodesoxycholique
Acide ursodesoxycholique [INN-French]
Acido ursodeossicolico
Acido ursodeossicolico [Italian]
Acido ursodeoxicolico
Acido ursodeoxicolico [INN-Spanish]
Acidum ursodeoxycholicum
Acidum ursodeoxycholicum [INN-Latin]
ACT02676
Actigall
Actigall (TN)
AKOS015955898
Antigall
AOB5075
API0004557
Arsacol
BDBM53721
BPBio1_001052
BRD-K15697815-001-16-2
BRN 3219888
BSPBio_000956
C-21580
C07880
CAS#128-13-2
CC-35557
CCG-220958
CCRIS 5502
CHEBI:9907
CHEMBL1551
Cholan-24-oic acid, 3,7-dihydroxy-, (3-alpha,5-beta,7-beta)-
Cholan-24-oic acid, 3,7-dihydroxy-, (3-alpha,5-beta,7-beta)- (9CI)
Cholan-24-oic acid, 3,7-dihydroxy-, (3.alpha.,5.beta.,7.beta.)-
Cholan-24-oic acid, 3,7-dihydroxy-, (3a,5b,7b)-
Cholan-24-oic acid, 3,7-dihydroxy-, (3alpha,5beta,7beta)-
Cholit-ursan
cid_31401
CPD000058403
CS-1932
D00734
DB01586
Delursan
Deoxyursocholic Acid
Desol
Destolit
Deursil
Dom-ursodiol c
DTXSID6023731
EC 204-879-3
EINECS 204-879-3
GTPL7104
HMS1570P18
HMS2097P18
HMS2233L14
HMS3259A13
HMS3714P18
HY-13771
ISO-URSODEOXYCHOLIC ACID
IU5
J-005566
J-650210
J10139
KB-276923
KS-5243
Litursol
LMST04010033
LS-53033
Lyeton
MCULE-4374611501
MFCD00003680
MLS000028461
MLS001066373
MLS002548885
MolPort-001-794-630
NC00487
NCGC00179363-01
NCI60_028904
NSC 657950
NSC 683769
Paptarom
Peptarom
PHL-ursodiol c
PMS-ursodiol c
Prestwick0_000958
Prestwick1_000958
Prestwick2_000958
Prestwick3_000958
RUDATBOHQWOJDD-UZVSRGJWSA-N
s1643
SCHEMBL27200
SMP2_000012
SMR000058403
Solutrat
SPBio_003105
SR-01000737091
SR-01000737091-3
SR-01000737091-4
ST24050336
U-9000
U0030
UDCA
UDCS
Udiliv
UNII-724L30Y2QR
Urdes
Urosdesoxycholate
Urosdesoxycholic acid
Urosiol
Ursacholic Acid
Ursacol
UrSO
Urso (TN)
Urso 250
Urso DS
Urso Forte
Ursobilin
Ursochol
Ursocholic acid, deoxy-
Ursodamor
ursodeoxycholate
URSODEOXYCHOLIC ACID
Ursodeoxycholic acid (JP17/INN)
Ursodeoxycholic acid [INN]
Ursodeoxycholic acid for system suitability, European Pharmacopoeia (EP) Reference Standard
Ursodeoxycholic acid, >=99%
Ursodeoxycholic acid, 500 mug/mL in methanol, certified reference material
Ursodeoxycholic acid, 99%
Ursodeoxycholic acid, British Pharmacopoeia (BP) Reference Standard
Ursodeoxycholic acid, European Pharmacopoeia (EP) Reference Standard
Ursodeoxycholicacid
Ursodeoxycholoc acid
Ursodesoxycholic acid
Ursodesoxycholic acid (UDCA)
Ursodexycholate
Ursodexycholic Acid
Ursodiol (Actigal Urso)
Ursodiol (Ursodeoxycholic Acid)
Ursodiol (USP)
Ursodiol [USAN:USP]
Ursodiol [USAN]
Ursodiol, Pharmaceutical Secondary Standard; Certified Reference Material
Ursodiol, United States Pharmacopeia (USP) Reference Standard
Ursofalk
Ursolvan
Ursosan
Z2786051717
ZINC3914809

US Patents and Regulatory Information for ursodiol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glenmark Generics URSODIOL ursodiol TABLET;ORAL 090801-001 Jul 12, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Par Pharm URSODIOL ursodiol TABLET;ORAL 202540-002 Feb 14, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa URSODIOL ursodiol TABLET;ORAL 079184-001 May 13, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Glenmark Generics URSODIOL ursodiol TABLET;ORAL 090801-002 Jul 12, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus URSODIOL ursodiol TABLET;ORAL 211145-001 Oct 30, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
>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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