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Generated: July 15, 2018

DrugPatentWatch Database Preview

Ursodiol - Generic Drug Details

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

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

There are seven drug master file entries for ursodiol. Twenty-four suppliers are listed for this compound.
Pharmacology for ursodiol
Ingredient-typeBile Acids and Salts
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[8.7.0.0(2),?.0(1)(1),(1)?]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 ,7 -Dihydroxy-5 -holan-24-oic acid
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,7b-dihydroxy-5b-cholan-24-oate
3a,7b-dihydroxy-5b-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 -Cholan-24-oic acid-3 ,7 -diol
5 beta-Cholan-24-oic acid-3alpha,7 beta-diol
5-beta-Cholan-24-oic acid
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
5beta-Cholan-24-oic acid-3alpha,7beta-diol
5beta-Cholanic Acid-3alpha,7beta-diol
7 -Hydroxylithocholic acid
7 beta-Hydroxylithocholic acid
7-beta-Hydroxylithocholic acid
7.beta.-Hydroxylithocholic acid
724L30Y2QR
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
BB_NC-2372
BDBM53721
BPBio1_001052
BRN 3219888
BSPBio_000956
BT000675
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)-(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
D0G3SH
DB01586
Delursan
Deoxyursocholic Acid
Desol
Destolit
Deursil
Deursil (TN)
Dom-ursodiol c
DTXSID6023731
EC 204-879-3
EINECS 204-879-3
GTPL7104
HMS1570P18
HMS2097P18
HMS2233L14
HMS3259A13
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
PL057793
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-01000737091-4
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
Urso Forte (TN)
Ursobilin
Ursochol
Ursocholic acid, deoxy-
ursocol
Ursodamor
Ursodeoxy cholic acid
ursodeoxycholate
URSODEOXYCHOLIC ACID
Ursodeoxycholic acid (JP15/INN)
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% 1g
Ursodeoxycholic acid, British Pharmacopoeia (BP) Reference Standard
Ursodeoxycholic acid, European Pharmacopoeia (EP) Reference Standard
Ursodeoxycholic acid, UDCA, Ursosan, Ursofalk, Urso Forte, Udiliv, Ursodiol
Ursodeoxycholicacid
Ursodeoxycholoc acid
Ursodesoxycholic acid
Ursodesoxycholic acid (UDCA)
Ursodesoxycholicacid
Ursodexycholate
Ursodexycholic Acid
Ursodiol (Actigal Urso)
Ursodiol (Ursodeoxycholic Acid)
Ursodiol (USP)
Ursodiol [USAN:USP]
Ursodiol [USAN]
Ursodiol, pharmaceutical secondary standard; traceable to USP, PhEur
Ursodiol, United States Pharmacopeia (USP) Reference Standard
Ursofalk
Ursolvan
Ursosan
Ursosan (TN)
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
Par Pharm URSODIOL ursodiol TABLET;ORAL 202540-001 Feb 14, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Glenmark Generics URSODIOL ursodiol TABLET;ORAL 090801-002 Jul 12, 2011 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Epic Pharma URSODIOL ursodiol CAPSULE;ORAL 075517-001 Mar 14, 2000 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva Pharms URSODIOL ursodiol CAPSULE;ORAL 075592-001 May 25, 2000 AB RX No No ➤ 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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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Express Scripts
Chubb
Johnson and Johnson
Citi
Mallinckrodt
Queensland Health
Accenture
Dow

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.