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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

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

Sponsor	Phase
Costantine Albany	Phase 2
Albert Einstein College of Medicine, Inc.	Phase 2
Jacobi Medical Center	Phase 2

See all rolapitant hydrochloride clinical trials

Pharmacology for rolapitant hydrochloride

Drug Class	Substance P/Neurokinin-1 Receptor Antagonist
Mechanism of Action	Neurokinin 1 Antagonists Cytochrome P450 2D6 Inhibitors Breast Cancer Resistance Protein Inhibitors P-Glycoprotein Inhibitors

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			Y	Y
Tersera Theraps Llc	VARUBI	rolapitant hydrochloride	TABLET;ORAL	206500-001	Sep 1, 2015		RX	Yes	Yes
Tersera Theraps Llc	VARUBI	rolapitant hydrochloride	TABLET;ORAL	206500-001	Sep 1, 2015		RX	Yes	Yes
Tersera Theraps Llc	VARUBI	rolapitant hydrochloride	TABLET;ORAL	206500-001	Sep 1, 2015		RX	Yes	Yes
Tersera Theraps Llc	VARUBI	rolapitant hydrochloride	EMULSION;INTRAVENOUS	208399-001	Oct 25, 2017		DISCN	Yes	No
Tersera Theraps Llc	VARUBI	rolapitant hydrochloride	TABLET;ORAL	206500-001	Sep 1, 2015		RX	Yes	Yes

International Patents for rolapitant hydrochloride

Country	Patent Number	Estimated Expiration
European Patent Office	2004646
China	103751186
Peru	12202007
Japan	6041919
Spain	2406934
Japan	2005513068

Supplementary Protection Certificates for rolapitant hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1463716	C20170033 00237	Estonia		PRODUCT NAME: ROLAPITANT;REG NO/DATE: EU/1/17/1180 24.04.2017
1463716	PA2017032,C1463716	Lithuania		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		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		PRODUCT NAME: ROLAPITANT - VARUBY; AUTHORISATION NUMBER AND DATE: EU/1/17/1180 20170424
2004646	300898	Netherlands		PRODUCT NAME: ROLAPITANT HYDROCHLORIDE-MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/17/1180 20170424
2004646	C201730041	Spain		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