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Serving hundreds of leading biopharmaceutical companies globally:

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Mallinckrodt
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Generated: October 18, 2018

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Obeticholic acid - Generic Drug Details

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What are the generic drug sources for obeticholic acid and what is the scope of obeticholic acid patent protection?

Obeticholic acid is the generic ingredient in one branded drug marketed by Intercept Pharms Inc and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for obeticholic acid. One supplier is listed for this compound.

Summary for obeticholic acid
Pharmacology for obeticholic acid
Synonyms for obeticholic acid
(3alpha,5beta,6alpha,7alpha,8xi)-6-Ethyl-3,7-dihydroxycholan-24-oic acid
(3alpha,5beta,6alpha,7alpha)-6-Ethyl-3,7-dihydroxycholan-24-oic acid
(4R)-4-[(1S,2S,5R,7S,8R,9R,10S,11S,14R,15R)-8-ethyl-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,8R,9R,10S,11S,14R,15R)-8-ETHYL-5,9-DIHYDROXY-2,15-DIMETHYLTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADECAN-14-YL]PENTANOIC ACID
(4R)-4-[(3R,5S,6R,7R,8S,9S,10S,13R,14S,17R)-6-ethyl-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
(R)-4-((3R,5S,6R,7R,8S,9S,10S,13R,14S,17R)-6-ethyl-3,7-dihydroxy-10,13-dimethyl-hexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)pentanoic acid
(R)-4-((3R,5S,6R,7R,8S,9S,10S,13R,14S,17R)-6-ethyl-3,7-dihydroxy-10,13-dimethylhexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)pentanoic acid
0462Z4S4OZ
1osv
3alpha,7alpha-dihydroxy-6alpha-ethyl-5beta-cholan-24-oic acid
459789-99-2
6-ECDCA
6-Et CDCA
6-Ethyl-CDCA
6-ETHYL-CHENODEOXYCHOLIC ACID
6-ETHYL-ISO-URSODEOXYCHOLIC ACID
6-Ethylchenodeoxycholic acid
6alpha-ethyl-3alpha,7alpha-dihydroxy-5beta-cholan-24-oic acid
6alpha-Ethyl-chenodeoxycholic acid
6alpha-ethylchenodeoxycholic acid
6ECDCA
AC1L9L5G
AK-78140
AKOS024259126
AN-28276
BDBM21675
C15636
CHEBI:43602
CHEMBL566315
Cholan-24-oic acid, 6-ethyl-3,7-dihydroxy-, (3alpha,5beta,6alpha,7alpha)-
CS-3813
CTK8E7311
D09360
D0M4WA
DB05990
DSP-1747
DTXSID20196671
EX-A387
GS-6103
GTPL3435
HY-12222
INT 747
INT-747
INT747
IU6
MolPort-035-682-579
Obeticholic acid (JAN/USAN/INN)
Obeticholic acid [USAN:INN]
Ocaliva
Ocaliva (TN)
PL008513
RT-010630
SCHEMBL715823
UNII-0462Z4S4OZ
Y1328
ZINC14164617
ZXERDUOLZKYMJM-ZWECCWDJSA-N

US Patents and Regulatory Information for obeticholic acid

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-002 May 27, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-002 May 27, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-001 May 27, 2016 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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Supplementary Protection Certificates for obeticholic acid

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2017 00025 Denmark ➤ Try a Free Trial PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215
90020-0 Sweden ➤ Try a Free Trial PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215
2017000034 Germany ➤ Try a Free Trial PRODUCT NAME: OBETICHOLSAEURE (OBETICHOLIC ACID); REGISTRATION NO/DATE: EU/1/16/1139 20161212
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Cipla
Teva
Cerilliant
AstraZeneca
Chubb
Mallinckrodt
Fish and Richardson
Fuji

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.