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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Baxter
Fuji
Harvard Business School
Colorcon
Chinese Patent Office
Deloitte
AstraZeneca
Cerilliant

Generated: April 20, 2018

DrugPatentWatch Database Preview

VARUBI Drug Profile

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

Varubi is a drug marketed by Tesaro Inc and is included in two NDAs. There are nine patents protecting this drug.

This drug has one hundred and fifty-three patent family members in thirty-four countries.

The generic ingredient in VARUBI is rolapitant hydrochloride. One supplier is listed for this compound. Additional details are available on the rolapitant hydrochloride profile page.
Summary for VARUBI
International Patents:153
US Patents:9
Applicants:1
NDAs:2
Suppliers / Packagers: 1
Bulk Api Vendors: 27
Clinical Trials: 4
Patent Applications: 4
Drug Prices:see details
DailyMed Link:VARUBI at DailyMed
Drug patent expirations by year for VARUBI
Synonyms for VARUBI
(5S,8S)-8-(((1R)-1-(3,5-bis(Trifluoromethyl)phenyl)ethoxy)methyl)-8-phenyl-1,7-diazaspiro(4.5)decan-2-one monohydrochloride monohydrate
(5S,8S)-8-(((R)-1-(3,5-bis(trifluoromethyl)phenyl)ethoxy)methyl)-8-phenyl-1,7-diazaspiro[4.5]decan-2-one
(5S,8S)-8-({(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy}methyl)-2-oxo-8-phenyl-1,7-diazaspiro[4.5]decan-7-ium chloride
(5S,8S)-8-({(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy}methyl)-2-oxo-8-phenyl-1,7-diazaspiro[4.5]decan-7-ium chloride--water (1/1)
(5S,8S)-8-({(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy}methyl)-8-phenyl-1,7-diazaspiro[4.5]decan-2-one
(5S,8S)-8-({(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy}methyl)-8-phenyl-1,7-diazaspiro[4.5]decan-2-one hydrochloride
(5S,8S)-8-({(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy}methyl)-8-phenyl-1,7-diazaspiro[4.5]decan-2-one hydrochloride--water (1/1)
(5S,8S)-8-[[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]methyl]-8-phenyl-1,9-diazaspiro[4.5]decan-2-one
1-Methyl-4-[3-(5-nitro-2-furanyl)-1-oxo-2-propenyl]-piperazine
1,7-Diazaspiro(4.5)decan-2-one, 8-(((1R)-1-(3,5-bis(trifluoromethyl)phenyl)ethoxy)methyl)-8-phenyl-, monohydrochloride, (5S,8S)-
1,7-Diazaspiro(4.5)decan-2-one, 8-(((1R)-1-(3,5-bis(trifluoromethyl)phenyl)ethoxy)methyl)-8-phenyl-, monohydrochloride, monohydrate, (5S,8S)-
552292-08-7
57O5S1QSAQ
858102-79-1
914462-92-3
943029-75-2
AKOS027250926
AKOS030234023
API0014111
B5910
BC600524
bis(trifluoromethyl)phenyl]ethoxy]methyl]-8-phenyl-1,9-diazaspiro[4.5]decan-2-one
CHEBI:90908
CHEBI:90911
CHEBI:90912
CHEMBL3707330
CHEMBL3707331
CS-6387
D08988
D0CF0Y
D10742
DB09291
DTXSID40235091
DTXSID70238570
DTXSID90203740
EX-A1288
FT-0700330
GTPL5749
HY-14751
J-690322
J7Z9DBN8J0
MFCD23105917
MolPort-035-942-975
MolPort-044-567-688
NLE429IZUC
PB37313
Q-4560
QC-11703
Rolapitant
Rolapitant (USAN/INN)
Rolapitant [USAN:INN]
Rolapitant HCl
Rolapitant hydrochloride
rolapitant hydrochloride (anhydrous)
Rolapitant hydrochloride (USAN)
Rolapitant hydrochloride [USAN]
Rolapitant hydrochloride anhydrous
Rolapitant hydrochloride hydrate
rolapitant monohydrochloride
rolapitant monohydrochloride monohydrate
rolapitant.HCl
rolapitant.HCl.H2O
Rolapitant(sch619734)
Sch 619734
SCH-619734
SCH619734
SCHEMBL2173125
SCHEMBL354305
UNII-57O5S1QSAQ
UNII-J7Z9DBN8J0
UNII-NLE429IZUC
Varubi (TN)
ZINC3816514

US Patents and Regulatory Information for VARUBI

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Tesaro Inc VARUBI rolapitant hydrochloride EMULSION;IV (INFUSION) 208399-001 Oct 25, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Tesaro Inc VARUBI rolapitant hydrochloride EMULSION;IV (INFUSION) 208399-001 Oct 25, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Tesaro Inc VARUBI rolapitant hydrochloride EMULSION;IV (INFUSION) 208399-001 Oct 25, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Tesaro Inc VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for VARUBI

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
9,688,693 NK.sub.1 antagonists ➤ Sign Up
9,345,692 Pharmaceutical formulations: salts of 8-[1-3,5-bis-(trifluoromethyl)phenyl)-ethoxy-methyl]-8-phenyl-1,7-diaza-s- piro[4.5]decan-2-one and treatment methods using the same ➤ Sign Up
7,902,366 NK.sub.1 antagonists ➤ Sign Up
8,273,895 NK.sub.1 antagonists ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for VARUBI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2017032 Lithuania ➤ Sign Up PRODUCT NAME: ROLAPITANTAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS, ISKAITANT ROLAPITANTO HIDROCHLORIDO MONOHIDRATA; REGISTRATION NO/DATE: EU/1/17/1180/001 20170420
0898 Netherlands ➤ Sign Up PRODUCT NAME: ROLAPITANT HYDROCHLORIDE-MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/17/1180 20170424
0895 Netherlands ➤ Sign Up PRODUCT NAME: ROLAPITANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, MET INBEGRIP VAN ROLAPITANT HYDROCHLORIDEMONOHYDRAAT; REGISTRATION NO/DATE: EU/1/17/1180/001 20170424
2017 00041 Denmark ➤ Sign Up PRODUCT NAME: ROLAPITANT, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, INKLUSIV ROLAPITANT-HYDROCHLORID-MONOHYDRAT; REG. NO/DATE: EU/1/17/1180 20170424
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Deloitte
McKesson
Boehringer Ingelheim
Julphar
US Department of Justice
Citi
Covington
Dow

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