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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Deloitte
Boehringer Ingelheim
Fuji
Cipla
AstraZeneca
Daiichi Sankyo
Queensland Health
Johnson and Johnson

Generated: June 22, 2018

DrugPatentWatch Database Preview

Obeticholic acid - Generic Drug Details

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What are the generic sources for obeticholic acid and what is the scope of obeticholic acid 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 four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Obeticholic acid has forty-four patent family members in twenty-four countries.

There is one drug master file entry for obeticholic acid. One supplier is listed for this compound.
Summary for obeticholic acid
International Patents:44
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Suppliers / Packagers: 1
Bulk Api Vendors: 35
Clinical Trials: 16
Patent Applications: 50
DailyMed Link:obeticholic acid at DailyMed
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 Y ➤ 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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Non-Orange Book US Patents for obeticholic acid

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,786,102 Steroids as agonists for FXR ➤ Try a Free Trial
8,969,330 Steroids as agonists for FXR ➤ Try a Free Trial
9,732,117 Steroids as agonists for FXR ➤ Try a Free Trial
9,732,116 Preparation and uses of obeticholic acid ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for obeticholic acid

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2017000034 Germany ➤ Try a Free Trial PRODUCT NAME: OBETICHOLSAEURE (OBETICHOLIC ACID); REGISTRATION NO/DATE: EU/1/16/1139 20161212
0877 Netherlands ➤ Try a Free Trial PRODUCT NAME: OBETICHOLZUUR; REGISTRATION 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
/2017 Austria ➤ Try a Free Trial PRODUCT NAME: OBETICHOLSAEURE, DESSEN PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE ODER AMINOSAEURE-KONJUGATE; 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:

Baxter
QuintilesIMS
Farmers Insurance
McKesson
UBS
Covington
Moodys
AstraZeneca
Teva

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