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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Chubb
Queensland Health
Fuji
Cantor Fitzgerald
Healthtrust
AstraZeneca
Cerilliant
Merck

Generated: April 24, 2018

DrugPatentWatch Database Preview

OCALIVA Drug Profile

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Which patents cover Ocaliva, and when can generic versions of Ocaliva launch?

Ocaliva is a drug marketed by Intercept Pharms Inc and is included in one NDA. There are four patents protecting this drug.

This drug has forty-four patent family members in twenty-four countries.

The generic ingredient in OCALIVA is obeticholic acid. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the obeticholic acid profile page.
Summary for OCALIVA
International Patents:44
US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 33
Patent Applications: 41
Drug Prices:see details
DailyMed Link:OCALIVA at DailyMed
Drug patent expirations by year for OCALIVA
Pharmacology for OCALIVA
Synonyms for OCALIVA
(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
Obeticholic acid (JAN/USAN/INN)
Obeticholic acid [USAN:INN]
Ocaliva (TN)
PL008513
RT-010630
SCHEMBL715823
UNII-0462Z4S4OZ
Y1328
ZINC14164617
ZXERDUOLZKYMJM-ZWECCWDJSA-N

US Patents and Regulatory Information for OCALIVA

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 207999-001 May 27, 2016 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-002 May 27, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-001 May 27, 2016 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-002 May 27, 2016 RX Yes Yes ➤ 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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Non-Orange Book US Patents for OCALIVA

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

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Supplementary Protection Certificates for OCALIVA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0877 Netherlands ➤ Sign Up PRODUCT NAME: OBETICHOLZUUR; REGISTRATION NO/DATE: EU/1/16/1139 20161215
/2017 Austria ➤ Sign Up PRODUCT NAME: OBETICHOLSAEURE, DESSEN PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE ODER AMINOSAEURE-KONJUGATE; REGISTRATION NO/DATE: EU/1/16/1139 20161212
2017000034 Germany ➤ Sign Up PRODUCT NAME: OBETICHOLSAEURE (OBETICHOLIC ACID); REGISTRATION NO/DATE: EU/1/16/1139 20161212
2017 00025 Denmark ➤ Sign Up PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Cipla
Johnson and Johnson
Daiichi Sankyo
Cantor Fitzgerald
Fuji
McKesson
Mallinckrodt
US Department of Justice

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