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Generated: April 26, 2019

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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 seven patents protecting this drug.

This drug has eighty-eight patent family members in twenty-nine 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
Drug patent expirations by year for OCALIVA
Generic Entry Opportunity Date for OCALIVA
Generic Entry Date for OCALIVA*:
Constraining patent/regulatory exclusivity:
TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN COMBINATION WITH URSODEOXYCHOLIC ACID (UDCA) IN ADULTS WITH AN INADEQUATE RESPONSE TO UDCA, OR AS MONOTHERAPY IN ADULTS UNABLE TO TOLERATE UDCA
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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
(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
Obeticholic acid (JAN/USAN/INN)
Obeticholic acid [USAN:INN]
Ocaliva (TN)
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 207999-001 May 27, 2016 RX Yes No ➤ Sign Up ➤ Sign Up 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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Supplementary Protection Certificates for OCALIVA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1392714 23/2017 Austria ➤ Sign Up PRODUCT NAME: OBETICHOLSAEURE, DESSEN PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE ODER AMINOSAEURE-KONJUGATE; REGISTRATION NO/DATE: EU/1/16/1139 20161212
1392714 CR 2017 00025 Denmark ➤ Sign Up PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215
1392714 1790020-0 Sweden ➤ Sign Up PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215
1392714 LUC00018 Luxembourg ➤ Sign Up PRODUCT NAME: ACIDE OBETICHOLIQUE ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (OCALIVA); AUTHORISATION NUMBER AND DATE: EU/1/16/1139 20161215
1392714 CA 2017 00025 Denmark ➤ Sign Up PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

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Colorcon

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