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Last Updated: December 14, 2019

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Obeticholic acid - Generic Drug Details

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

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

Obeticholic acid has ninety-seven patent family members in thirty-one countries.

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

Summary for obeticholic acid
International Patents:97
US Patents:7
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Suppliers / Packagers: 1
Bulk Api Vendors: 41
Clinical Trials: 20
Patent Applications: 63
DailyMed Link:obeticholic acid at DailyMed
Recent Clinical Trials for obeticholic acid

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

SponsorPhase
GlaxoSmithKlinePhase 1
Sir Salimullah Medical College Mitford HospitalN/A
Intercept PharmaceuticalsPhase 4

See all obeticholic acid clinical trials

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
(3beta,5beta,6alpha,7beta)-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-[(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
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
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)
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   Start Trial   Start Trial Y   Start Trial
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-002 May 27, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-002 May 27, 2016 RX Yes Yes   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

Supplementary Protection Certificates for obeticholic acid

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1392714 122017000034 Germany   Start Trial PRODUCT NAME: OBETICHOLSAEURE; REGISTRATION NO/DATE: EU/1/16/1139 20161212
1392714 CR 2017 00025 Denmark   Start Trial PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215
1392714 17C0003 France   Start Trial PRODUCT NAME: ACIDE OBETICHOLIQUE; REGISTRATION NO/DATE: EU/1/16/1139 20161212
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.