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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^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: ⤷ Subscribe NDA: 208399 Dosage: EMULSION;INTRAVENOUS
Generic Entry Dates for VARUBI^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: ⤷ Subscribe 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

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 ⤷ Subscribe.

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

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

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: ⤷ Subscribe

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: ⤷ Subscribe

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: ⤷ Subscribe

Japan

Patent: 42459
Estimated Expiration: ⤷ Subscribe

Patent: 63134
Estimated Expiration: ⤷ Subscribe

Patent: 41919
Estimated Expiration: ⤷ Subscribe

Patent: 10522173
Estimated Expiration: ⤷ Subscribe

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: ⤷ Subscribe

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: ⤷ Subscribe

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: ⤷ Subscribe

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: ⤷ Subscribe

Spain

Patent: 06934
Estimated Expiration: ⤷ Subscribe

Taiwan

Patent: 50185
Estimated Expiration: ⤷ Subscribe

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: ⤷ Subscribe

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
Japan	2014240437	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−オンの塩酸塩およびその調製プロセス (8-[{1-(3,5-BIS-(TRIFLUOROMETHYL)PHENYL)-ETHOXY}-METHYL]-8-PHENYL-1,7-DIAZA-SPIRO[4.5]DECANE-2-ONE HYDROCHLORIDE AND PREPARATION PROCESS THEREOF)	⤷ Subscribe
Japan	2013501806		⤷ Subscribe
South Korea	20120060215	INTRAVENOUS FORMULATIONS OF NEUROKININ-1 ANTAGONISTS	⤷ Subscribe
Germany	60225067		⤷ Subscribe
Russian Federation	2642234	КОМПОЗИЦИИ АНТАГОНИСТОВ НЕЙРОКИНИНА-1 ДЛЯ ВНУТРИВЕННОГО ВВЕДЕНИЯ (ANTAGONISTS NEUROKININ-1 COMPOSITIONS FOR INTRAVENOUS INTRODUCTION)	⤷ Subscribe
Taiwan	I363058		⤷ Subscribe
Singapore	10201500028R	PHARMACEUTICAL FORMULATIONS: SALTS OF 8-[{1-(3,5-BIS-(TRIFLUOROMETHYL)PHENYL)-ETHOXY}-METHYL]-8-PHENYL-1,7-DIAZA-SPIRO[4.5]DECAN-2-ONE AND TREATMENT METHODS USING THE SAME	⤷ Subscribe
>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	2017/042	Ireland	⤷ Subscribe	PRODUCT NAME: ROLAPITANT, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING ROLAPITANT HYDROCHLORIDE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/17/1180 20170420
1463716	46/2017	Austria	⤷ Subscribe	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	CR 2017 00041	Denmark	⤷ Subscribe	PRODUCT NAME: ROLAPITANT, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, INKLUSIV ROLAPITANT-HYDROCHLORID-MONOHYDRAT; REG. NO/DATE: EU/1/17/1180 20170424
1463716	17C1037	France	⤷ Subscribe	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	C201730043	Spain	⤷ Subscribe	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	C 2017 036	Romania	⤷ Subscribe	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	PA2017032	Lithuania	⤷ Subscribe	PRODUCT NAME: ROLAPITANTAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS, ISKAITANT ROLAPITANTO HIDROCHLORIDO MONOHIDRATA; REGISTRATION NO/DATE: EU/1/17/1180/001 20170420
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

VARUBI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Varubi

Introduction to Varubi

Varubi, also known as rolapitant, is a neurokinin-1 (NK1) receptor antagonist developed by TESARO, Inc. (now part of GSK) for the prevention of chemotherapy-induced nausea and vomiting (CINV). It is available in both oral and intravenous (IV) formulations.

Market Overview

The global market for CINV drugs, which includes Varubi, is projected to grow significantly. By 2031, the market is estimated to reach $4.3 billion, expanding at a CAGR of 8.2% driven by advances in medications and an increase in highly effective agents[1].

Geographical Market Presence

Varubi has a strong presence in key geographical markets. North America, particularly the U.S., represents the largest market share for CINV drugs, followed by Europe. The Asia Pacific region is also expected to exhibit significant growth due to increasing market penetration by generic manufacturers[1].

Product Performance and Revenue

Oral Formulation

The oral formulation of Varubi has seen substantial growth. In the fourth quarter of 2017, unit demand for Varubi oral tablets increased by 43% compared to the same period in 2016, indicating strong market penetration in the U.S. oral NK-1 market[2].

IV Formulation

However, the IV formulation of Varubi faced challenges. Following the reporting of serious hypersensitivity reactions, including anaphylaxis and anaphylactic shock, TESARO suspended the distribution of Varubi IV and redirected resources to support the oral tablets. The company explored strategic alternatives, such as out-licensing, for the IV product[2].

Financial Performance

Revenue

In 2017, Varubi sales contributed significantly to TESARO's revenue. Net product sales for Varubi totaled $11.9 million for the full year, with $4.5 million of that coming from the fourth quarter alone. This was a marked increase from 2016, when Varubi sales were $2.3 million[2].

Cost of Sales and Expenses

The cost of sales associated with Varubi was impacted by inventory write-downs and other charges related to revised expectations for future Varubi IV revenue. Additionally, intangible asset amortization increased due to the amortization of milestones recorded upon FDA and European Commission approvals of Varubi[2].

Research and Development Expenses

TESARO's R&D expenses increased significantly in 2017, partly due to higher manufacturing costs and the expansion of clinical development programs, including those related to Varubi[2].

Market Drivers and Challenges

Increasing Incidence of Cancer

The growing number of patients undergoing chemotherapy is a key driver for the CINV drugs market. The global cancer population is expected to rise, with approximately 60% of new cases identified in Asia, Africa, and the Americas[4].

Technological Advancements

Technological advancements, such as the development of new drug delivery methods like transdermal systems, are improving patient compliance and driving market growth. Varubi itself is an example of such innovation, developed using new technologies to target the NK1 receptor[4].

High Drug Costs

Despite the advancements, high drug costs remain a significant challenge for the CINV market. The expensive nature of these drugs can restrain market growth, although the benefits of effective antiemetic therapy often outweigh the costs[4].

Competitive Landscape

Varubi competes in a market with several other antiemetic drugs, including SUSTOL (Granisetron Injection – extended release), 5-HT3-receptor antagonists (5-HT3RAs), and other NK1 receptor antagonists. Companies like Acacia Pharma, Helsinn Holding S.A., Heron Therapeutics, Inc., and Eisai Pharmaceutical Pvt Ltd. are major players in this space[1][4].

Strategic Focus

TESARO's strategy for Varubi involved leveraging the experience and competencies of its management team to commercialize the drug effectively. The company focused on direct commercialization in North America and partnerships in Europe and China. Establishing a network of licensees and distributors in other geographic areas was also a key part of their strategy[3].

Key Takeaways

Market Growth: The CINV drugs market, including Varubi, is expected to grow significantly, reaching $4.3 billion by 2031.
Geographical Presence: North America and Europe are the dominant markets, with the Asia Pacific region showing promising growth.
Product Performance: Varubi oral tablets have seen strong growth, while the IV formulation faced challenges.
Financial Impact: Varubi contributed substantially to TESARO's revenue, despite costs associated with inventory write-downs and R&D expenses.
Market Drivers: Increasing cancer incidence and technological advancements are key drivers, while high drug costs are a challenge.
Competitive Landscape: Varubi competes with other antiemetic drugs and companies in the CINV market.

FAQs

1. What is Varubi used for? Varubi (rolapitant) is used for the prevention of chemotherapy-induced nausea and vomiting (CINV).

2. What are the different formulations of Varubi? Varubi is available in both oral and intravenous (IV) formulations.

3. Why was the distribution of Varubi IV suspended? The distribution of Varubi IV was suspended due to reports of serious hypersensitivity reactions, including anaphylaxis and anaphylactic shock.

4. How has the market for CINV drugs been growing? The global market for CINV drugs is expected to reach $4.3 billion by 2031, growing at a CAGR of 8.2%.

5. What are some of the key drivers for the CINV drugs market? Key drivers include the increasing number of patients undergoing chemotherapy and technological advancements in drug delivery methods.

Cited Sources:

Global CINV Drugs Market $4.3 Billion by 2031 - iHealthcareAnalyst
TESARO Announces Fourth-Quarter and Full-Year 2017 Operating Results - GlobeNewswire
TESARO, INC. - Annual Reports - AnnualReports.com
Netupitant - Palonosetron FDC Market Size - Analysis 2022 - Allied Market Research

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