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Last Updated: April 4, 2020

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ZONTIVITY Drug Profile


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Which patents cover Zontivity, 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
University of FloridaPhase 4
Merck Sharp & Dohme Corp.Phase 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
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
618385-01-6
705260-08-8
A1-03410
ACN-048227
AKOS030524402
AS-35235
AS-56098
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, sulfate (1:1)
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-[(1E)-2-[5-(3-fluorophenyl)-2-pyridinyl]ethenyl]dodecahydro-1-methyl-3-oxonaphtho[2,3-c]furan-6-yl]-, ethyl ester, sulfate (1:1)
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
CHEBI:83314
CHEMBL2107386
CHEMBL493982
CS-0002462
CS-5527
D09765
D09766
DB09030
DTXSID201009336
DTXSID60990731
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)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)vinyl)-1-methyl-3-oxododecahydronaphtho[2,3-C]furan-6-ylcarbamate
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 [(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 [(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;sulfuric acid
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-A1149
EX-A1343
GTPL4047
HY-10119
HY-10119A
IN66038E6C
MK 5348
MK-5348
MLS006010324
Q27156749
Q7941753
s8067
Sch 530348
SCH 530348 H2SO4 Salt
SCH 530348 sulfate
SCH 530348 sulfate; Vorapaxar sulfate; MK5348
SCH 530348|||MK-5348
SCH-530348
SCH530348
SCHEMBL3399110
SCHEMBL471187
SMR004701388
Sulfuric acid--ethyl hydrogen (9-{2-[5-(3-fluorophenyl)pyridin-2-yl]ethenyl}-1-methyl-3-oxododecahydronaphtho[2,3-c]furan-6-yl)carbonimidate (1/1)
UNII-IN66038E6C
UNII-ZCE93644N2
Vorapaxar
Vorapaxar (SCH 530348)
Vorapaxar (sulfate)
Vorapaxar (USAN/INN)
Vorapaxar [USAN:INN]
vorapaxar monosulfate
VORAPAXAR SULFATE
Vorapaxar sulfate (JAN/USAN)
Vorapaxar sulfate [USAN]
Y1927
ZCE93644N2
ZINC3925861
Zontivity (TN)

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
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 C 2015 030 Romania   Start Trial PRODUCT NAME: VORAPAXAR SAU O SARE ACCEPTABILA FARMACEUTIC SAU SOLVATAL ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/14/976/001, EU/1/14/976/002, EU/1/14/976/003, EU/1/14/976/004, EU/1/14/976/005, EU/1/14/976/006; DATE OF NATIONAL AUTHORISATION: 20150119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/976/001, EU/1/14/976/002, EU/1/14/976/003, EU/1/14/976/004, EU/1/14/976/005, EU/1/14/976/006; DATE OF FIRST AUTHORISATION IN EEA: 20150119
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 122015000053 Germany   Start Trial PRODUCT NAME: VORAPAXAR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/14/976/001-006 20150119
1495018 15C0047 France   Start Trial PRODUCT NAME: VORAPAXAR,OU L'UN DE SES SELS OU SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/14/976/001-006 20150121
1495018 S1500036 Hungary   Start Trial PRODUCT NAME: VORAPAXAR; REGISTRATION NO/DATE: EU/1/14/976 20150119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Colorcon
Boehringer Ingelheim
McKesson
Moodys
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.