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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 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:	35
Patent Applications:	41
DailyMed Link:	OCALIVA at DailyMed

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

(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
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	207999-002	May 27, 2016		RX	Yes	Yes

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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
7,786,102	Steroids as agonists for FXR
9,732,117	Steroids as agonists for FXR
9,732,116	Preparation and uses of obeticholic acid
8,969,330	Steroids as agonists for FXR

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International Patents for OCALIVA

Country	Document Number	Estimated Expiration
European Patent Office	1392714
Mexico	2014016062
Israel	236231
Japan	2017075169

Supplementary Protection Certificates for OCALIVA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2017000034	Germany		PRODUCT NAME: OBETICHOLSAEURE (OBETICHOLIC ACID); REGISTRATION NO/DATE: EU/1/16/1139 20161212
2017 00025	Denmark		PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215
2017 00025	Denmark		PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215
90020-0	Sweden		PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215