Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 13, 2019

DrugPatentWatch Database Preview

VARUBI Drug Profile

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Summary for VARUBI
International Patents:159
US Patents:9
Applicants:1
NDAs:2
Suppliers / Packagers: 2
Bulk Api Vendors: 44
Clinical Trials: 5
Patent Applications: 34
DailyMed Link:VARUBI at DailyMed
Drug patent expirations by year for VARUBI
Generic Entry Opportunity Date for VARUBI
Generic Entry Dates for VARUBI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
EMULSION;IV (INFUSION)
Generic Entry Dates for VARUBI*:
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 VARUBI

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

SponsorPhase
Costantine AlbanyPhase 2
Tesaro, Inc.Phase 2
Duke UniversityPhase 2

See all VARUBI clinical trials

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--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--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
1,7-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
914462-92-3
ACN-055567
AKOS027250926
AKOS030234023
API0014111
B5910
BC600524
BCP09609
BCP15968
bis(trifluoromethyl)phenyl]ethoxy]methyl]-8-phenyl-1,9-diazaspiro[4.5]decan-2-one
CHEBI:90908
CHEBI:90911
CHEMBL3707330
CHEMBL3707331
CS-6387
D08988
D10742
DB09291
DTXSID70238570
DTXSID90203740
EX-A1288
FT-0700330
GTPL5749
HY-14751
MolPort-035-942-975
NLE429IZUC
PB37313
Q-4560
QC-11703
Rolapitant
Rolapitant (USAN/INN)
Rolapitant [USAN:INN]
Rolapitant HCl
Rolapitant hydrochloride
Rolapitant hydrochloride (USAN)
Rolapitant hydrochloride [USAN]
Rolapitant hydrochloride hydrate
rolapitant monohydrochloride monohydrate
rolapitant.HCl.H2O
Rolapitant(sch619734)
SB20554
Sch 619734
SCH-619734
SCH619734
SCHEMBL2173125
SCHEMBL354305
UNII-57O5S1QSAQ
UNII-NLE429IZUC
Varubi (TN)
Varuby
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
Tersera Theraps Llc VARUBI rolapitant hydrochloride EMULSION;INTRAVENOUS 208399-001 Oct 25, 2017 DISCN Yes No   Start Trial   Start Trial   Start Trial
Tersera Theraps Llc VARUBI rolapitant hydrochloride EMULSION;INTRAVENOUS 208399-001 Oct 25, 2017 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Tersera Theraps Llc VARUBI rolapitant hydrochloride EMULSION;INTRAVENOUS 208399-001 Oct 25, 2017 DISCN Yes No   Start Trial   Start Trial   Start Trial
Tersera Theraps Llc VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Tersera Theraps Llc VARUBI rolapitant hydrochloride EMULSION;INTRAVENOUS 208399-001 Oct 25, 2017 DISCN Yes No   Start Trial   Start Trial   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 VARUBI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1463716 C20170033 00237 Estonia   Start Trial PRODUCT NAME: ROLAPITANT;REG NO/DATE: EU/1/17/1180 24.04.2017
1463716 PA2017032,C1463716 Lithuania   Start Trial PRODUCT NAME: ROLAPITANTAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS, ISKAITANT ROLAPITANTO HIDROCHLORIDO MONOHIDRATA; REGISTRATION NO/DATE: EU/1/17/1180/001 20170420
1463716 1790044-0 Sweden   Start Trial PRODUCT NAME: ROLAPITANT, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING ROLAPITANT HYDROCHLORIDE MONOHYDRATE; REG. NO/DATE: EU/1/17/1180/001 20170424
1463716 2017C/039 Belgium   Start Trial PRODUCT NAME: ROLAPITANT - VARUBY; AUTHORISATION NUMBER AND DATE: EU/1/17/1180 20170424
2004646 300898 Netherlands   Start Trial PRODUCT NAME: ROLAPITANT HYDROCHLORIDE-MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/17/1180 20170424
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Moodys
Johnson and Johnson
Medtronic
Merck
Harvard Business School

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 verifification 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.