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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 Tersera Theraps Llc and is included in two NDAs. There are nine patents protecting this drug.

This drug has one hundred and fifty-nine patent family members in thirty-five countries.

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

Summary for VARUBI

International Patents:	159
US Patents:	9
Applicants:	1
NDAs:	2
Suppliers / Packagers:	2
Bulk Api Vendors:	44
Clinical Trials:	5
Patent Applications:	34
DailyMed Link:	VARUBI at DailyMed

Generic Entry Opportunity Date for VARUBI

NDA:

208399

Dosage:

EMULSION;IV (INFUSION)

NDA:

206500

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for VARUBI

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

Sponsor	Phase
Costantine Albany	Phase 2
Tesaro, Inc.	Phase 2
Duke University	Phase 2

See all VARUBI clinical trials

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--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--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

1,7-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

914462-92-3

ACN-055567

AKOS027250926

AKOS030234023

API0014111

B5910

BC600524

BCP09609

BCP15968

bis(trifluoromethyl)phenyl]ethoxy]methyl]-8-phenyl-1,9-diazaspiro[4.5]decan-2-one

CHEBI:90908

CHEBI:90911

CHEMBL3707330

CHEMBL3707331

CS-6387

D08988

D10742

DB09291

DTXSID70238570

DTXSID90203740

EX-A1288

FT-0700330

GTPL5749

HY-14751

MolPort-035-942-975

NLE429IZUC

PB37313

Q-4560

QC-11703

Rolapitant

Rolapitant (USAN/INN)

Rolapitant [USAN:INN]

Rolapitant HCl

Rolapitant hydrochloride

Rolapitant hydrochloride (USAN)

Rolapitant hydrochloride [USAN]

Rolapitant hydrochloride hydrate

rolapitant monohydrochloride monohydrate

rolapitant.HCl.H2O

Rolapitant(sch619734)

SB20554

Sch 619734

SCH-619734

SCH619734

SCHEMBL2173125

SCHEMBL354305

UNII-57O5S1QSAQ

UNII-NLE429IZUC

Varubi (TN)

Varuby

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
Tersera Theraps Llc	VARUBI	rolapitant hydrochloride	EMULSION;INTRAVENOUS	208399-001	Oct 25, 2017		DISCN	Yes	No
Tersera Theraps Llc	VARUBI	rolapitant hydrochloride	EMULSION;INTRAVENOUS	208399-001	Oct 25, 2017		DISCN	Yes	No			Y	Y
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
Tersera Theraps Llc	VARUBI	rolapitant hydrochloride	EMULSION;INTRAVENOUS	208399-001	Oct 25, 2017		DISCN	Yes	No

International Patents for VARUBI

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

Supplementary Protection Certificates for VARUBI

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