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

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Last Updated: November 13, 2019

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Rolapitant hydrochloride - Generic Drug Details

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What are the generic drug sources for rolapitant hydrochloride and what is the scope of freedom to operate?

Rolapitant hydrochloride is the generic ingredient in one branded drug marketed by Tersera Theraps Llc and is included in two NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Rolapitant hydrochloride has one hundred and fifty-nine patent family members in thirty-five countries.

Two suppliers are listed for this compound.

Summary for rolapitant hydrochloride
International Patents:159
US Patents:9
Tradenames:1
Applicants:1
NDAs:2
Suppliers / Packagers: 2
Bulk Api Vendors: 12
Clinical Trials: 13
Patent Applications: 5
DailyMed Link:rolapitant hydrochloride at DailyMed
Recent Clinical Trials for rolapitant hydrochloride

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SponsorPhase
Costantine AlbanyPhase 2
Albert Einstein College of Medicine, Inc.Phase 2
Jacobi Medical CenterPhase 2

See all rolapitant hydrochloride clinical trials

Synonyms for rolapitant hydrochloride
(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-({(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 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)
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)-
57O5S1QSAQ
858102-79-1
914462-92-3
943029-75-2
AKOS027250926
API0014111
BCP15968
CHEBI:90911
CHEBI:90912
CHEMBL3707330
D08988
DTXSID40235091
DTXSID70238570
J-690322
J7Z9DBN8J0
MolPort-044-567-688
Rolapitant HCl
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
SCH619734
SCHEMBL2173125
UNII-57O5S1QSAQ
UNII-J7Z9DBN8J0
Varubi

US Patents and Regulatory Information for rolapitant hydrochloride

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 TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes   Start Trial   Start Trial Y Y   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 TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes   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
Tersera Theraps Llc VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes   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 rolapitant hydrochloride

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
2004646 C201730041 Spain   Start Trial PRODUCT NAME: ROLAPITANT CLORHIDRATO MONOHIDRATO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1180; DATE OF AUTHORISATION: 20170420; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1180; DATE OF FIRST AUTHORISATION IN EEA: 20170420
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim
Express Scripts
McKinsey
Mallinckrodt
Merck

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.