VARUBI Drug Patent Profile

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 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. 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

Summary for VARUBI

International Patents:	159
US Patents:	9
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	7
Patent Applications:	358
What excipients (inactive ingredients) are in VARUBI?	VARUBI excipients list
DailyMed Link:	VARUBI at DailyMed

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for VARUBI

NDA:

208399

Dosage:

EMULSION;INTRAVENOUS

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

Anatomical Therapeutic Chemical (ATC) Classes for VARUBI

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

US Patents and Regulatory Information for VARUBI

VARUBI is protected by nine US patents.

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

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

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

Canada

Chile

European Patent Office

Japan

Mexico

Peru

Spain

Taiwan

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.

Country	Patent Number	Title	Estimated Expiration
Norway	20084660
China	101437821	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
Denmark	1463716
Russian Federation	2004122109

Supplementary Protection Certificates for VARUBI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2004646	C201730041	Spain		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	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
1463716	300895	Netherlands		PRODUCT NAME: ROLAPITANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, MET INBEGRIP VAN ROLAPITANT HYDROCHLORIDEMONOHYDRAAT; REGISTRATION NO/DATE: EU/1/17/1180/001 20170424
1463716	609	Finland