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Generated: June 25, 2018

DrugPatentWatch Database Preview

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 ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Tesaro Inc VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Tesaro Inc VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 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
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 ➤ Sign Up
7,902,366 NK.sub.1 antagonists ➤ Sign Up
8,273,895 NK.sub.1 antagonists ➤ Sign Up
9,688,693 NK.sub.1 antagonists ➤ Sign Up
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
2017000080 Germany ➤ Sign Up PRODUCT NAME: ROLAPITANT, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH ROLAPITANT HYDROCHLORID-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1180 20170420
2017031 Lithuania ➤ Sign Up PRODUCT NAME: ROLAPITANTO HIDROCHLORIDO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/17/1180/001 20170420
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
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Medtronic
AstraZeneca
Cantor Fitzgerald
Cipla
Deloitte
Healthtrust
McKesson
Citi

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