ROLAPITANT HYDROCHLORIDE - Generic Drug Details

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

Dosage:

EMULSION;INTRAVENOUS

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
ECONiX Araştırma Analiz ve Danışmanlık A.Ş.	Phase 2
PlusVitech S.L.	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

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

Expired US Patents for ROLAPITANT HYDROCHLORIDE

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

International Patents for ROLAPITANT HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Japan	2013501806
Norway	2017053
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)

Supplementary Protection Certificates for ROLAPITANT HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	122017000080	Germany		PRODUCT NAME: ROLAPITANT, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH ROLAPITANT HYDROCHLORID-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1180 20170420
1463716	46/2017	Austria		PRODUCT NAME: ROLAPITANT, OPTIONAL IN DER FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, EINSCHLIESSLICH ROLAPITANT-HYDROCHLORID-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1180 (MITTEILUNG) 20170424