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 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
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
Anatomical Therapeutic Chemical (ATC) Classes for VARUBI
US Patents and Regulatory Information for VARUBI
VARUBI is protected by nine US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of VARUBI is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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
NK.sub.1 antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY
Pharmaceutical formulations: salts of 8-[{1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaz- a-spiro[4.5]decan-2-one and treatment methods using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Pharmaceutical formulations: salts of 8-[{1-(3,5-bis-(trifluoromethyl)phenyl)-Ethoxy}-methyl]-8-phenyl-1,7-diaz- a-spiro[4.5]decan-2-one and treatment methods using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY
Hydrochloride salts of 8-[{1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy)-methyl]-8-phenyl-1,7-diaz- a-spiro[4.5]decan-2-one and preparation process therefor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Tablet formulations containing 8-[{1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaz- a-spiro[4.5]decan-2-one salts and tablets made therefrom
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Pharmaceutical formulations:salts of 8-[1-3,5-bis-(trifluoromethyl)phenyl)-ethoxymethyl]-8-phenyl-1,7-diaza-sp- iro[4.5]decan-2-one and treatment methods using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY
NK1 antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY
Intravenous formulations of neurokinin-1 antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Tersera | VARUBI | rolapitant hydrochloride | EMULSION;INTRAVENOUS | 208399-001 | Oct 25, 2017 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Tersera | VARUBI | rolapitant hydrochloride | EMULSION;INTRAVENOUS | 208399-001 | Oct 25, 2017 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Tersera | VARUBI | rolapitant hydrochloride | TABLET;ORAL | 206500-001 | Sep 1, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity 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
Estimated Expiration: See Plans and Pricing
Canada
Patent: 81465
Estimated Expiration: See Plans and Pricing
Chile
Patent: 08000819
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 36793
Estimated Expiration: See Plans and Pricing
Japan
Patent: 42459
Estimated Expiration: See Plans and Pricing
Patent: 63134
Estimated Expiration: See Plans and Pricing
Patent: 41919
Estimated Expiration: See Plans and Pricing
Patent: 10522173
Estimated Expiration: See Plans and Pricing
Patent: 13216694
Estimated Expiration: See Plans and Pricing
Patent: 15108023
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 09010210
Estimated Expiration: See Plans and Pricing
Peru
Patent: 081891
Estimated Expiration: See Plans and Pricing
Spain
Patent: 06934
Estimated Expiration: See Plans and Pricing
Taiwan
Patent: 50185
Estimated Expiration: See Plans and Pricing
Patent: 0902087
Estimated Expiration: See Plans and Pricing
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 | See Plans and Pricing | |
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 | See Plans and Pricing |
Denmark | 1463716 | See Plans and Pricing | |
Russian Federation | 2004122109 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VARUBI
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2004646 | C201730041 | Spain | See Plans and Pricing | 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 | See Plans and Pricing | 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 | See Plans and Pricing | 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 | See Plans and Pricing | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |