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VARUBI Drug Profile

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When do Varubi patents expire, and when can generic versions of Varubi launch?

Varubi is a drug marketed by Tesaro Inc and is included in two NDAs. There are nine patents protecting this drug.

This drug has one hundred and fifty-three patent family members in thirty-four countries.

The generic ingredient in VARUBI is rolapitant hydrochloride. One supplier is listed for this compound. Additional details are available on the rolapitant hydrochloride profile page.

Summary for VARUBI

International Patents:	153
US Patents:	9
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	27
Clinical Trials:	4
Patent Applications:	4
Drug Prices:	see details
DailyMed Link:	VARUBI at DailyMed

Pharmacology for VARUBI

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 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

(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

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 (TN)

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
Tesaro Inc	VARUBI	rolapitant hydrochloride	EMULSION;IV (INFUSION)	208399-001	Oct 25, 2017		RX	Yes	Yes
Tesaro Inc	VARUBI	rolapitant hydrochloride	EMULSION;IV (INFUSION)	208399-001	Oct 25, 2017		RX	Yes	Yes			Y	Y
Tesaro Inc	VARUBI	rolapitant hydrochloride	EMULSION;IV (INFUSION)	208399-001	Oct 25, 2017		RX	Yes	Yes
Tesaro Inc	VARUBI	rolapitant hydrochloride	TABLET;ORAL	206500-001	Sep 1, 2015		RX	Yes	Yes

Non-Orange Book US Patents for VARUBI

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
9,688,693	NK.sub.1 antagonists
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
7,902,366	NK.sub.1 antagonists
8,273,895	NK.sub.1 antagonists

International Patents for VARUBI

Country	Document Number	Estimated Expiration
China	1606545
Taiwan	I350185
European Patent Office	2662374
Peru	12202007

Supplementary Protection Certificates for VARUBI

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2017032	Lithuania		PRODUCT NAME: ROLAPITANTAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS, ISKAITANT ROLAPITANTO HIDROCHLORIDO MONOHIDRATA; REGISTRATION NO/DATE: EU/1/17/1180/001 20170420
0898	Netherlands		PRODUCT NAME: ROLAPITANT HYDROCHLORIDE-MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/17/1180 20170424
0895	Netherlands		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
2017 00041	Denmark		PRODUCT NAME: ROLAPITANT, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, INKLUSIV ROLAPITANT-HYDROCHLORID-MONOHYDRAT; REG. NO/DATE: EU/1/17/1180 20170424