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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 ninety-seven patent family members in thirty-one 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:	97
US Patents:	7
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	41
Patent Applications:	54
Drug Prices:	Drug price information for OCALIVA
DailyMed Link:	OCALIVA at DailyMed

See drug prices for OCALIVA

Generic Entry Opportunity 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:

207999

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

Drug Class	Farnesoid X Receptor Agonist
Mechanism of Action	Farnesoid X Receptor Agonists

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
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016		RX	Yes	Yes
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016		RX	Yes	No			Y	Y
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016		RX	Yes	No				Y
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016		RX	Yes	Yes

International Patents for OCALIVA

Country	Patent Number	Estimated Expiration
European Patent Office	2861613
World Intellectual Property Organization (WIPO)	2013192097
Australia	2016200832
Japan	2018538331
Australia	2016255045

Supplementary Protection Certificates for OCALIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1392714	122017000034	Germany		PRODUCT NAME: OBETICHOLSAEURE; REGISTRATION NO/DATE: EU/1/16/1139 20161212
1392714	2017/019	Ireland		PRODUCT NAME: OBETICHOLIC ACID; REGISTRATION NO/DATE: EU/1/16/1139/001 EU/1/16/1139/002 20161212
1392714	CR 2017 00025	Denmark		PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215
1392714	LUC00018	Luxembourg		PRODUCT NAME: ACIDE OBETICHOLIQUE ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (OCALIVA); AUTHORISATION NUMBER AND DATE: EU/1/16/1139 20161215
1392714	17C0003	France		PRODUCT NAME: ACIDE OBETICHOLIQUE; REGISTRATION NO/DATE: EU/1/16/1139 20161212