VARUBI Drug Patent Profile
✉ Email this page to a colleague
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 April 4, 2027. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for VARUBI?
- What are the global sales for VARUBI?
- What is Average Wholesale Price for VARUBI?
Summary for VARUBI
| International Patents: | 158 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 106 |
| Clinical Trials: | 7 |
| Patent Applications: | 885 |
| What excipients (inactive ingredients) are in VARUBI? | VARUBI excipients list |
| DailyMed Link: | VARUBI at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VARUBI
Generic Entry Dates for VARUBI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
EMULSION;INTRAVENOUS |
Generic Entry Dates for VARUBI*:
Constraining patent/regulatory exclusivity:
NDA:
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 |
Pharmacology for VARUBI
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 ⤷ Start Trial.
This potential generic entry date is based on patent ⤷ Start Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
| 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 | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Tersera | VARUBI | rolapitant hydrochloride | TABLET;ORAL | 206500-001 | Sep 1, 2015 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Tersera | VARUBI | rolapitant hydrochloride | EMULSION;INTRAVENOUS | 208399-001 | Oct 25, 2017 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Tersera | VARUBI | rolapitant hydrochloride | TABLET;ORAL | 206500-001 | Sep 1, 2015 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Tersera | VARUBI | rolapitant hydrochloride | TABLET;ORAL | 206500-001 | Sep 1, 2015 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Tersera | VARUBI | rolapitant hydrochloride | EMULSION;INTRAVENOUS | 208399-001 | Oct 25, 2017 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Tersera | VARUBI | rolapitant hydrochloride | EMULSION;INTRAVENOUS | 208399-001 | Oct 25, 2017 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Tersera | VARUBI | rolapitant hydrochloride | EMULSION;INTRAVENOUS | 208399-001 | Oct 25, 2017 | ⤷ Start Trial | ⤷ Start Trial |
| Tersera | VARUBI | rolapitant hydrochloride | TABLET;ORAL | 206500-001 | Sep 1, 2015 | ⤷ Start Trial | ⤷ Start Trial |
| >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: ⤷ Start Trial
Canada
Patent: 48604
Estimated Expiration: ⤷ Start Trial
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: ⤷ Start Trial
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: ⤷ Start Trial
China
Patent: 2276606
Estimated Expiration: ⤷ Start Trial
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: ⤷ Start Trial
Patent: 62373
Estimated Expiration: ⤷ Start Trial
Patent: 62374
Estimated Expiration: ⤷ Start Trial
Japan
Patent: 52446
Estimated Expiration: ⤷ Start Trial
Patent: 42459
Estimated Expiration: ⤷ Start Trial
Patent: 63134
Estimated Expiration: ⤷ Start Trial
Patent: 41919
Estimated Expiration: ⤷ Start Trial
Patent: 09532472
Estimated Expiration: ⤷ Start Trial
Patent: 10522173
Estimated Expiration: ⤷ Start Trial
Patent: 13032404
Estimated Expiration: ⤷ Start Trial
Patent: 13216694
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 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: ⤷ Start Trial
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: ⤷ Start Trial
Lithuania
Patent: 2017031
Estimated Expiration: ⤷ Start Trial
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: ⤷ Start Trial
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: ⤷ Start Trial
Portugal
Patent: 04646
Estimated Expiration: ⤷ Start Trial
Spain
Patent: 06934
Estimated Expiration: ⤷ Start Trial
Taiwan
Patent: 0815439
Estimated Expiration: ⤷ Start Trial
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: ⤷ Start Trial
Patent: 50185
Estimated Expiration: ⤷ Start Trial
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 |
|---|---|---|---|
| Argentina | 037851 | ANTAGONISTAS DE NEUROQUININA, COMPOSICIONES FARMACEUTICAS Y EL USO DE DICHOS COMPUESTOS PARA LA PREPARACION DE MEDICAMENTOS | ⤷ Start Trial |
| Argentina | 093413 | ANTAGONISTAS DE NEUROQUININA, COMPOSICIONES FARMACEUTICAS QUE LOS COMPRENDEN, Y USO DE DICHOS ANTAGONISTAS EN LA PREPARACION DE UN MEDICAMENTO | ⤷ Start Trial |
| Austria | 386023 | ⤷ Start Trial | |
| Austria | 522504 | ⤷ Start Trial | |
| Australia | 2002357264 | ⤷ Start Trial | |
| Brazil | 0215158 | ⤷ Start Trial | |
| Brazil | PI0215158 | compostos derivados de pirrolidina e piperidina como antagonistas de nk1, composição farmacêutica e uso dos mesmos | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VARUBI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2004646 | 300898 | Netherlands | ⤷ Start Trial | PRODUCT NAME: ROLAPITANT HYDROCHLORIDE-MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/17/1180 20170424 |
| 2004646 | PA2017031 | Lithuania | ⤷ Start Trial | PRODUCT NAME: ROLAPITANTO HIDROCHLORIDO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/17/1180/001 20170420 |
| 1463716 | 300895 | Netherlands | ⤷ Start Trial | 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 | CR 2017 00041 | Denmark | ⤷ Start Trial | PRODUCT NAME: ROLAPITANT, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, INKLUSIV ROLAPITANT-HYDROCHLORID-MONOHYDRAT; REG. NO/DATE: EU/1/17/1180 20170424 |
| 1463716 | PA2017032 | Lithuania | ⤷ Start Trial | PRODUCT NAME: ROLAPITANTAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS, ISKAITANT ROLAPITANTO HIDROCHLORIDO MONOHIDRATA; REGISTRATION NO/DATE: EU/1/17/1180/001 20170420 |
| 2004646 | 122017000079 | Germany | ⤷ Start Trial | PRODUCT NAME: ROLAPITANT HYDROCHLORID-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1180 20170420 |
| 1463716 | 122017000080 | Germany | ⤷ Start Trial | PRODUCT NAME: ROLAPITANT, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH ROLAPITANT HYDROCHLORID-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1180 20170420 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
DrugChatter Q&A for VARUBI
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2026 - 2027
NCE-1 Patent Challenge Dates 2026 - 2027
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch