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VARUBI Drug Patent Profile

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Which patents cover Varubi, and when can generic versions of Varubi launch?

Varubi is a drug marketed by Tersera and is included in two NDAs. There are eight patents protecting this drug.

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

DrugPatentWatch^® Generic Entry Outlook for Varubi

Varubi was eligible for patent challenges on September 1, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 19, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for VARUBI

International Patents:	158
US Patents:	8
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	7
Patent Applications:	263
What excipients (inactive ingredients) are in VARUBI?	VARUBI excipients list
DailyMed Link:	VARUBI at DailyMed

Drug patent expirations by year for VARUBI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VARUBI

Generic Entry Dates for VARUBI^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 208399 Dosage: EMULSION;INTRAVENOUS
Generic Entry Dates for VARUBI^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
ECONiX Araştırma Analiz ve Danışmanlık A.Ş.	Phase 2
PlusVitech S.L.	Phase 2
Costantine Albany	Phase 2

See all VARUBI clinical trials

Pharmacology for VARUBI

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

US Patents and Regulatory Information for VARUBI

VARUBI is protected by eight US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VARUBI is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VARUBI

NK.sub.1 antagonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY

Pharmaceutical formulations: salts of 8-[{1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaz- a-spiro[4.5]decan-2-one and treatment methods using the same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Pharmaceutical formulations: salts of 8-[{1-(3,5-bis-(trifluoromethyl)phenyl)-Ethoxy}-methyl]-8-phenyl-1,7-diaz- a-spiro[4.5]decan-2-one and treatment methods using the same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY

Hydrochloride salts of 8-[{1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy)-methyl]-8-phenyl-1,7-diaz- a-spiro[4.5]decan-2-one and preparation process therefor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Tablet formulations containing 8-[{1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaz- a-spiro[4.5]decan-2-one salts and tablets made therefrom
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Pharmaceutical formulations:salts of 8-[1-3,5-bis-(trifluoromethyl)phenyl)-ethoxymethyl]-8-phenyl-1,7-diaza-sp- iro[4.5]decan-2-one and treatment methods using the same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY

Hydrochloride salts of 8-[{1-(3,5-Bis-trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaza- -spiro[4.5]decan-2-one and preparation process therefor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY

Intravenous formulations of neurokinin-1 antagonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tersera	VARUBI	rolapitant hydrochloride	EMULSION;INTRAVENOUS	208399-001	Oct 25, 2017		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Tersera	VARUBI	rolapitant hydrochloride	TABLET;ORAL	206500-001	Sep 1, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Tersera	VARUBI	rolapitant hydrochloride	EMULSION;INTRAVENOUS	208399-001	Oct 25, 2017		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Tersera	VARUBI	rolapitant hydrochloride	TABLET;ORAL	206500-001	Sep 1, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Tersera	VARUBI	rolapitant hydrochloride	TABLET;ORAL	206500-001	Sep 1, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for VARUBI

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Tersera	VARUBI	rolapitant hydrochloride	EMULSION;INTRAVENOUS	208399-001	Oct 25, 2017	⤷ Sign Up	⤷ Sign Up
Tersera	VARUBI	rolapitant hydrochloride	TABLET;ORAL	206500-001	Sep 1, 2015	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for VARUBI

When does loss-of-exclusivity occur for VARUBI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 5802
Patent: FORMULACIONES DE COMPRIMIDOS QUE CONTIENEN SALES DE 8- [( 1- ( 3,5- BIS- (TRIFLUOROMETIL) FENIL) -ETOXI ) - METIL) -8- FENIL -1, 7- DIAZA- SPIRO [ 4,5] DECAN -2- ONA Y COMPRIMIDOS ELABORADOS A PARTIR DE ESTAS
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 81465
Patent: FORMULATIONS POUR COMPRIMES CONTENANT DES SELS DE 8-[{1-(3,5-BIS- (TRIFLUOROMETHYL)PHENYL)-ETHOXY}-METHYL]-8-PHENYL-1,7-DIAZA-SPIRO[4,5]- DECAN-2-ONE ET COMPRIMES (TABLET FORMULATIONS CONTAINING 8-[{1-(3,5-BIS-(TRIFLUOROMETHYL)PHENYL)-ETHOXY}-METHYL]-8-PHENYL-1,7-DIAZA-SPIRO[4.5]DECAN-2-ONE SALTS AND TABLETS MADE THEREFROM)
Estimated Expiration: ⤷ Sign Up

Chile

Patent: 08000819
Patent: COMPOSICION FARMACEUTICA EN POLVO QUE COMPRENDE UN GRANULADO QUE COMPRENDE AL MENOS UNA SAL CRISTALINA DE (5S,8S)-8-[{(1R)-(3,5-BIS-(TRIFLUOROMETIL)FENIL)-ETOXI}-8-FENIL-1,7-DIAZA-SPIRO[4.5]DECAN-2-ONA; GRANULADO Y COMPRIMIDO; Y USO PARA EL TRATAMIEN
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 36793
Patent: FORMULATIONS POUR COMPRIMÉS CONTENANT DES SELS DE 8-[{1-(3,5-BIS- (TRIFLUOROMÉTHYL)PHÉNYL)-ÉTHOXY}-MÉTHYL]-8-PHÉNYL-1,7-DIAZA-SPIRO[4,5]- DÉCAN-2-ONE ET COMPRIMÉS (TABLET FORMULATIONS CONTAINING 8-[{1-(3,5-BIS-(TRIFLUOROMETHYL)PHENYL)-ETHOXY}-METHYL]-8-PHENYL-1,7-DIAZA-SPIRO[4.5]DECAN-2-ONE SALTS AND TABLETS MADE THEREFROM)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 42459
Estimated Expiration: ⤷ Sign Up

Patent: 63134
Estimated Expiration: ⤷ Sign Up

Patent: 41919
Estimated Expiration: ⤷ Sign Up

Patent: 10522173
Estimated Expiration: ⤷ Sign Up

Patent: 13216694
Patent: TABLET FORMULATION CONTAINING SALT OF 8-[{1-(3,5-BIS-(TRIFLUOROMETHYL)PHENYL)-ETHOXY}-METHYL]-8-PHENYL-1,7-DIAZA-SPIRO[4.5]DECAN-2-ONE, AND TABLET PREPARED FROM THE SAME
Estimated Expiration: ⤷ Sign Up

Patent: 15108023
Patent: ８−［｛１−（３，５−ビス−（トリフルオロメチル）フェニル）−エトキシ｝−メチル］−８−フェニル−１，７−ジアザ−スピロ［４．５］デカン−２−オンの塩を含む錠剤処方物およびそれから作製される錠剤 (TABLET FORMULATIONS CONTAINING 8-[{1-(3,5-BIS-(TRIFLUOROMETHYL)PHENYL)-ETHOXY}-METHYL]-8-PHENYL-1,7-DIAZA-SPIRO[4.5]DECAN-2-ONE SALTS AND TABLETS FORMED THEREFROM)
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 09010210
Patent: FORMULACIONES DE COMPRIMIDOS QUE CONTIENEN SALES DE 8-[{1-(3,5-BIS-(TRIFLUOROMETIL)FENIL)-ETOXI}-METIL]-8-FENIL-1,7-D IAZA-SPIRO[4.5]DECAN-2-ONA Y COMPRIMIDOS ELABORADOS A PARTIR DE ESTAS. (TABLET FORMULATIONS CONTAINING 8-[{1-(3,5-BIS-(TRIFLUOROMETHYL)PH ENYL)-ETHOXY}-METHYL]-8-PHENYL-1,7-DIAZA-SPIRO[4.5]DECAN-2-ONE SALTS AND TABLETS MADE THEREFROM.)
Estimated Expiration: ⤷ Sign Up

Peru

Patent: 081891
Patent: FORMULACIONES DE COMPRIMIDOS QUE CONTIENEN SALES DE 8-[{1-(3,5-BIS-(TRIFLUOROMETIL)FENIL)-ETOXI}-METIL]-8-FENIL-1,7-DIAZA-SPIRO[4.5]DECAN-2-ONA Y COMPRIMIDOS ELABORADOS A PARTIR DE ESTAS
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 06934
Estimated Expiration: ⤷ Sign Up

Taiwan

Patent: 50185
Estimated Expiration: ⤷ Sign Up

Patent: 0902087
Patent: Tablet formulations containing 8-[{1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaza-spiro[4.5]decan-2-one salts and tablets made therefrom
Estimated Expiration: ⤷ Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VARUBI around the world.

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2997964	FORMULATIONS PHARMACEUTIQUES COMPRENANT DES SELS DE (5S, 8S)-8-[{(1 R)-1-(3,5-BIS-TRIFLUOROMÉTHYLE) PHÉNYL]-ÉTHOXY} -MÉTHYL]-8-PHÉNYL-1,7-DIAZASPIRO[4.5]DECAN-2-UN ET LEUR UTILISATION MÉDICALE (PHARMACEUTICAL FORMULATIONS COMPRISING SALTS OF (5S,8S)-8-[{(1 R)-1-(3,5-BIS-TRIFLUOROMETHYL)PHENYL]- ETHOXY}-METHYL]-8-PHENYL-1,7-DIAZASPIRO[4.5]DECAN-2-ONE AND THEIR MEDICAL USE)	⤷ Sign Up
Mexico	336071	FORMULACIONES INTRAVENOSAS DE ANTAGONISTAS DE NEUROCININA 1. (INTRAVENOUS FORMULATIONS OF NEUROKININ-1 ANTAGONISTS.)	⤷ Sign Up
Japan	2012167125	PHARMACEUTICAL FORMULATIONS: SALT OF 8-[{1-(3,5-BIS-(TRIFLUOROMETHYL)PHENYL)-ETHOXY}-METHYL]-8-PHENYL-1,7-DIAZA-SPIRO[4.5]DECAN-2-ONE AND TREATMENT METHOD USING THE SAME	⤷ Sign Up
Chile	2007000945	Formulacion farmaceutica que comprende una sal cristalina de monohidrato de hidrocloruro de (5s,8s)-8-[[(1r)-1-(3,5-bistrifluorometil)fenil]-etoximetil]-8-fenil-1,7-diaza-espiro[4.5]decan-2-ona; capsula que la contiene; y uso en el tratamiento de la emesis y nausea.	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2007114921		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for VARUBI

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1463716	C20170033 00237	Estonia	⤷ Sign Up	PRODUCT NAME: ROLAPITANT;REG NO/DATE: EU/1/17/1180 24.04.2017
2004646	C201730041	Spain	⤷ Sign Up	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
1463716	C 2017 036	Romania	⤷ Sign Up	PRODUCT NAME: ROLAPITANT, OPTIONAL SUB FORMA UNEI SARI ACCEPTABILE FARMACEUTIC, INCLUSIV CLORHIDRAT DE ROLAPITANT MONOHIDRAT; NATIONAL AUTHORISATION NUMBER: EU/1/17/1180/001; DATE OF NATIONAL AUTHORISATION: 20170420; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1180/001; DATE OF FIRST AUTHORISATION IN EEA: 20170420
1463716	CR 2017 00041	Denmark	⤷ Sign Up	PRODUCT NAME: ROLAPITANT, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, INKLUSIV ROLAPITANT-HYDROCHLORID-MONOHYDRAT; REG. NO/DATE: EU/1/17/1180 20170424
2004646	2017C/040	Belgium	⤷ Sign Up	PRODUCT NAME: ROLAPITANT - VARUBY (SOUS FORME DE CHLORHYDRATE MONOHYDRATE); AUTHORISATION NUMBER AND DATE: EU/1/17/1180 20170424
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description