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Rolapitant hydrochloride - Generic Drug Details

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What are the generic 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 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:	19
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
Jacobi Medical Center	Phase 2
Albert Einstein College of Medicine, Inc.	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

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

International Patents for rolapitant hydrochloride

Country	Patent Number	Estimated Expiration
China	102276606
European Patent Office	2997964
Taiwan	I363058
Mexico	2012001872
Peru	20120545
South Korea	20120060215
Mexico	336071

Supplementary Protection Certificates for rolapitant hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2004646	2017C/040	Belgium		PRODUCT NAME: ROLAPITANT - VARUBY (SOUS FORME DE CHLORHYDRATE MONOHYDRATE); AUTHORISATION NUMBER AND DATE: EU/1/17/1180 20170424
1463716	C201730043	Spain		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	17C1037	France		PRODUCT NAME: ROLAPITANT, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ADMISSIBLE, INCLUANT LE MONOHYDRATE DE CHLORHYDRATE DE ROLAPITANT.; REGISTRATION NO/DATE: EU/1/17/1180 20170424
1463716	609	Finland
1463716	C20170033 00237	Estonia		PRODUCT NAME: ROLAPITANT;REG NO/DATE: EU/1/17/1180 24.04.2017
1463716	122017000080	Germany		PRODUCT NAME: ROLAPITANT, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH ROLAPITANT HYDROCHLORID-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1180 20170420
2004646	17C1038	France		PRODUCT NAME: MONOHYDRATE DE CHLORHYDRATE DE ROLAPITANT; NAT. REGISTRATION NO/DATE: EU/1/17/1180/001 20170424; FIRST REGISTRATION: EU/1/17/1180 20170424