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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Deloitte
Harvard Business School
Covington
UBS
Fish and Richardson
Cantor Fitzgerald
Chinese Patent Office
AstraZeneca

Generated: August 15, 2018

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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 rolapitant hydrochloride freedom to operate?

Rolapitant hydrochloride is the generic ingredient in one branded drug marketed by Tesaro Inc 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-three patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for rolapitant hydrochloride
International Patents:153
US Patents:9
Tradenames:1
Applicants:1
NDAs:2
Suppliers / Packagers: 1
Bulk Api Vendors: 36
Clinical Trials: 12
Patent Applications: 41
DailyMed Link:rolapitant hydrochloride at DailyMed
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-(((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 (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
Varubi (TN)
ZINC3816514

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
Tesaro Inc VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Tesaro Inc VARUBI rolapitant hydrochloride EMULSION;IV (INFUSION) 208399-001 Oct 25, 2017 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Tesaro Inc VARUBI rolapitant hydrochloride EMULSION;IV (INFUSION) 208399-001 Oct 25, 2017 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Tesaro Inc VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Tesaro Inc VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Tesaro Inc VARUBI rolapitant hydrochloride EMULSION;IV (INFUSION) 208399-001 Oct 25, 2017 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 rolapitant hydrochloride

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
9,345,692 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 ➤ Try a Free Trial
7,902,366 NK.sub.1 antagonists ➤ Try a Free Trial
8,273,895 NK.sub.1 antagonists ➤ Try a Free Trial
9,688,693 NK.sub.1 antagonists ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for rolapitant hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2017032 Lithuania ➤ Try a Free Trial PRODUCT NAME: ROLAPITANTAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS, ISKAITANT ROLAPITANTO HIDROCHLORIDO MONOHIDRATA; REGISTRATION NO/DATE: EU/1/17/1180/001 20170420
2017031 Lithuania ➤ Try a Free Trial PRODUCT NAME: ROLAPITANTO HIDROCHLORIDO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/17/1180/001 20170420
0895 Netherlands ➤ Try a Free Trial 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
2017000080 Germany ➤ Try a Free Trial PRODUCT NAME: ROLAPITANT, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH ROLAPITANT HYDROCHLORID-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1180 20170420
2017000079 Germany ➤ Try a Free Trial PRODUCT NAME: ROLAPITANT HYDROCHLORID-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1180 20170420
0898 Netherlands ➤ Try a Free Trial PRODUCT NAME: ROLAPITANT HYDROCHLORIDE-MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/17/1180 20170424
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Dow
Fish and Richardson
Accenture
Julphar
Merck
Covington
Moodys
Deloitte

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.