ROLAPITANT HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for rolapitant hydrochloride and what is the scope of patent protection?

Rolapitant hydrochloride is the generic ingredient in one branded drug marketed by Tersera and is included in two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Rolapitant hydrochloride has one hundred and fifty-eight patent family members in thirty-five countries.

One supplier is listed for this compound.

Summary for ROLAPITANT HYDROCHLORIDE

International Patents:	158
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	15
Patent Applications:	729
DailyMed Link:	ROLAPITANT HYDROCHLORIDE at DailyMed

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

Generic Entry Dates for ROLAPITANT HYDROCHLORIDE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: EMULSION;INTRAVENOUS
Generic Entry Dates for ROLAPITANT HYDROCHLORIDE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 ROLAPITANT HYDROCHLORIDE

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

Sponsor	Phase
Guangxi Medical University	Phase 3
PlusVitech S.L.	Phase 2
ECONiX Araştırma Analiz ve Danışmanlık A.Ş.	Phase 2

See all ROLAPITANT HYDROCHLORIDE clinical trials

Pharmacology for ROLAPITANT HYDROCHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for ROLAPITANT HYDROCHLORIDE

A04AD	Other antiemetics
A04A	ANTIEMETICS AND ANTINAUSEANTS
A04	ANTIEMETICS AND ANTINAUSEANTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for ROLAPITANT HYDROCHLORIDE

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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	TABLET;ORAL	206500-001	Sep 1, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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	Y		⤷ 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	Y	Y		⤷ 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
>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 ROLAPITANT HYDROCHLORIDE

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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 ROLAPITANT HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
Mexico	336071	FORMULACIONES INTRAVENOSAS DE ANTAGONISTAS DE NEUROCININA 1. (INTRAVENOUS FORMULATIONS OF NEUROKININ-1 ANTAGONISTS.)	⤷ Sign Up
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
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
Russian Federation	2012109405	КОМПОЗИЦИИ АНТАГОНИСТОВ НЕЙРОКИНИНА-1 ДЛЯ ВНУТРИВЕННОГО ВВЕДЕНИЯ	⤷ Sign Up
China	105503870	Intravenous formulations of neurokinin-1 antagonists	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ROLAPITANT HYDROCHLORIDE

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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
1463716	C201730043	Spain	⤷ Sign Up	PRODUCT NAME: ROLAPITANT, OPCIONALMENTE EN FORMA DE UNA SAL FARMACEUTICAMENTE ACEPTABLE, INCLUYENDO 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	2017C/039	Belgium	⤷ Sign Up	PRODUCT NAME: ROLAPITANT - VARUBY; AUTHORISATION NUMBER AND DATE: EU/1/17/1180 20170424
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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