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Last Updated: January 23, 2020

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ZONTIVITY Drug Profile

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When do Zontivity patents expire, and when can generic versions of Zontivity launch?

Zontivity is a drug marketed by Toprol and is included in one NDA. There are three patents protecting this drug.

This drug has one hundred and sixty-three patent family members in thirty-seven countries.

The generic ingredient in ZONTIVITY is vorapaxar sulfate. One supplier is listed for this compound. Additional details are available on the vorapaxar sulfate profile page.

US ANDA Litigation and Generic Entry Outlook for Zontivity

Zontivity was eligible for patent challenges on May 8, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 30, 2024. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ZONTIVITY
Drug patent expirations by year for ZONTIVITY
Drug Prices for ZONTIVITY

See drug prices for ZONTIVITY

Generic Entry Opportunity Date for ZONTIVITY
Generic Entry Date for ZONTIVITY*:
Constraining patent/regulatory exclusivity:
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.

Recent Clinical Trials for ZONTIVITY

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Vanderbilt University Medical CenterPhase 4
Merck Sharp & Dohme Corp.Phase 4
University of FloridaPhase 4

See all ZONTIVITY clinical trials

Pharmacology for ZONTIVITY
Synonyms for ZONTIVITY
(3R,3aalpha,4abeta,8aalpha,9aalpha)-3alpha-Methyl-4beta-[(E)-2-[5-(3-fluorophenyl)-2-pyridyl]ethenyl]-7beta-(ethoxycarbonylamino)dodecahydronaphtho[2,3-c]furan-1-one
[(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
[(1R,3aR,4aR,6R,8aR,9S,9aS)-9-{(E)-2-[5-(3-Fluorophenyl)-2-pyridinyl]vinyl}-1-methyl-3-oxododecahydronaphto[2,3-c]furan-6-yl]carbamate d'ethyle
618385-01-6
A1-03410
ACN-048227
AKOS027326789
BC600771
BDBM50261110
C29H33FN2O4
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
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
Carbamic acid, N-[(1R,3aR,4aR,6R,8aR,9S,9aS)-9-[(E)-2-[5-(3-fluorophenyl)-2-pyridinyl]ethenyl]dodecahydro-1-methyl-3-oxonaphtho[2,3-c]furan-6-yl]-, ethyl ester
CHEBI:82702
CHEMBL493982
CS-5527
D09765
DB09030
Ethyl ((1R,3aR,4aR,6R,8aR,9S,9aS)-9-((1E)-2-(5-(3-fluorophenyl)pyridin-2-yl)ethenyl)- 1-methyl-3-oxododecahydronaphtho(2,3-c)furan-6-yl)carbamate
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
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
Ethyl [(3aR,4aR,8aR,9aS)-9(S)-[(E)-2-[5-(3-fluorophenyl)-2-pyridinyl]ethenyl]dodecahydro-1(R)-methyl-3-oxonaphtho[2,3-c]furan-6(R)-yl]carbamate
Ethyl N-((1R,3aR,4aR,6R,8aR,9S)-9-((E)-2-(5-(3-fluorophenyl)pyridin-2-yl)ethenyl)-1-methyl-3-oxo-decahydro-1H-naphtho(2,3-c)furan-6-yl)carbamate
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
ethyl n-[(3r,3as,4s,4ar,7r,8ar,9ar)-4-[(e)-2-[5-(3-fluorophenyl)-2-pyridyl]vinyl]-3-methyl-1-oxo-3a,4,4a,5,6,7,8,8a,9,9a-decahydro-3h-benzo[f]isobenzofuran-7-yl]carbamate
ethyl N-[(3R,3aS,4S,4aR,7R,8aR,9aR)-4-[(E)-2-[5-(3-fluorophenyl)pyridin-2-yl]ethenyl]-3-methyl-1-oxo-3a,4,4a,5,6,7,8,8a,9,9a-decahydro-3H-naphtho[6,7-c]furan-7-yl]carbamate
EX-A1343
GTPL4047
HY-10119
KB-81455
MK-5348
MLS006010324
MolPort-039-062-225
s8067
SCH-530348
SCH530348
SCHEMBL3399110
SCHEMBL471187
SMR004701388
UNII-ZCE93644N2
Vorapaxar
Vorapaxar (SCH 530348)
Vorapaxar (USAN/INN)
Vorapaxar [USAN:INN]
Vorapaxar; MK 5348
Y1927
ZCE93644N2
ZINC3925861

US Patents and Regulatory Information for ZONTIVITY

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

Supplementary Protection Certificates for ZONTIVITY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1495018 C20150025 00159 Estonia   Start Trial PRODUCT NAME: VORAPAKSAAR;REG NO/DATE: EU/1/14/976 21.01.2015
1495018 CA 2015 00037 Denmark   Start Trial PRODUCT NAME: VORAPAXAR, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING VORAPAXARSULPHATE; REG. NO/DATE: EU/1/14/976/001-06 20150119
1495018 218 50011-2015 Slovakia   Start Trial PRODUCT NAME: VORAPAXARIUMSULFAT; REGISTRATION NO/DATE: EU/1/14/976/001 - EU/1/14/976/006 20150121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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