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Vorapaxar sulfate - Generic Drug Details

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What are the generic sources for vorapaxar sulfate and what is the scope of vorapaxar sulfate patent protection?

Vorapaxar sulfate is the generic ingredient in one branded drug marketed by Aralez Pharms and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Vorapaxar sulfate has one hundred and sixty-one patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for vorapaxar sulfate

International Patents:	161
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	22
Clinical Trials:	677
DailyMed Link:	vorapaxar sulfate at DailyMed

Pharmacology for vorapaxar sulfate

Drug Class	Protease-activated Receptor-1 Antagonist
Mechanism of Action	Protease-activated Receptor-1 Antagonists

Synonyms for vorapaxar sulfate

2-[(E)-2-{(3R,3aS,4S,4aR,7R,8aR,9aR)-7-[(ethoxycarbonyl)amino]-3-methyl-1-oxododecahydronaphtho[2,3-c]furan-4-yl}ethenyl]-5-(3-fluorophenyl)pyridinium hydrogen sulfate

705260-08-8

AKOS030524402

AN-9455

Carbamic acid, ((1R,3aR,4aR,6R,8aR,9S,9aS)-9-((1E)-2-(5-(3-fluorophenyl)-2-pyridinyl)ethenyl)dodecahydro-1-methyl-3-oxonaphtho(2,3-c)furan-6-yl)-, ethyl ester, sulfate (1:1)

CHEBI:83314

CHEMBL2107386

D09766

ethyl ((1R,3aR,4aR,6R,8aR,9S,9aS)-9-((E)-2-(5-(3-fluorophenyl)pyridin-2-yl)vinyl)-1-methyl-3-oxododecahydronaphtho[2,3-c]furan-6-yl)carbamate sulfate

ethyl [(1R,3aR,4aR,6R,8aR,9S,9aS)-9-{(E)-2-[5-(3-fluorophenyl)pyridin-2-yl]ethenyl}-1-methyl-3-oxododecahydronaphtho[2,3-c]furan-6-yl]carbamate sulfate

ethyl N-[(1R,3aR,4aR,6R,8aR,9S,9aS)-9-[(E)-2-[5-(3-fluorophenyl)-2-pyridyl]vinyl]-1-methyl-3-oxo-3a,4,4a,5,6,7,8,8a,9,9a-decahydro-1H-benzo[f]isobenzofuran-6-yl]carbamate; sulfuric acid

ethyl N-[(1R,3aR,4aR,6R,8aR,9S,9aS)-9-[(E)-2-[5-(3-fluorophenyl)pyridin-2-yl]ethenyl]-1-methyl-3-oxo-3a,4,4a,5,6,7,8,8a,9,9a-decahydro-1H-benzo[f][2]benzofuran-6-yl]carbamate;sulfuric acid

EX-A1149

IN66038E6C

KB-80525

MFCD16038877

MolPort-046-033-533

N-[(1R,3aR,4aR,6R,8aR,9S,9aS)-9-[(1E)-2-[5-(3-Fluorophenyl)-2-pyridinyl]ethenyl]dodecahydro-1-methyl-3-oxonaphtho[2,3-c]furan-6-yl]carbamic Acid Ethyl Ester Sulfate

Sch 530348

SCH 530348 H2SO4 Salt

SCH 530348 sulfate; Vorapaxar sulfate; MK5348

SCH 530348|||MK-5348

UNII-IN66038E6C

vorapaxar monosulfate

Vorapaxar sulfate (JAN/USAN)

Vorapaxar sulfate [USAN]

Zontivity (TN)

US Patents and Regulatory Information for vorapaxar sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aralez Pharms	ZONTIVITY	vorapaxar sulfate	TABLET;ORAL	204886-001	May 8, 2014		RX	Yes	Yes			Y	Y
Aralez Pharms	ZONTIVITY	vorapaxar sulfate	TABLET;ORAL	204886-001	May 8, 2014		RX	Yes	Yes			Y	Y
Aralez Pharms	ZONTIVITY	vorapaxar sulfate	TABLET;ORAL	204886-001	May 8, 2014		RX	Yes	Yes
Aralez Pharms	ZONTIVITY	vorapaxar sulfate	TABLET;ORAL	204886-001	May 8, 2014		RX	Yes	Yes			Y	Y

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Non-Orange Book US Patents for vorapaxar sulfate

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
6,645,987	Nor-seco himbacine derivatives useful as thrombin receptor antagonists
6,894,065	Thrombin receptor antagonists
7,488,742	Thrombin receptor antagonists

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International Patents for vorapaxar sulfate

Country	Document Number	Estimated Expiration
Taiwan	200530225
South Africa	200603686
Portugal	1495018
Hong Kong	1151285

Supplementary Protection Certificates for vorapaxar sulfate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
90037-6	Sweden		PRODUCT NAME: VORAPAXAR, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REG. NO/DATE: EU/1/14/976/001 20150121
2015027	Lithuania		PRODUCT NAME: VORAPAXARUM; REGISTRATION NO/DATE: EU/1/14/976/001 - EU/1/14/976/006 20150119
00746	Netherlands		PRODUCT NAME: VORAPAXAR IN ELKE DOOR HET; REGISTRATION NO/DATE: EU/1/14/976/001-006 20150119
8 50011-2015	Slovakia		PRODUCT NAME: VORAPAXARIUMSULFAT; REGISTRATION NO/DATE: EU/1/14/976/001 - EU/1/14/976/006 20150121