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
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: | 355 |
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
Anatomical Therapeutic Chemical (ATC) Classes 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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a 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.
Patents protecting VARUBI
NK.sub.1 antagonists
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY
Intravenous formulations of neurokinin-1 antagonists
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Tersera | VARUBI | rolapitant hydrochloride | TABLET;ORAL | 206500-001 | Sep 1, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Tersera | VARUBI | rolapitant hydrochloride | EMULSION;INTRAVENOUS | 208399-001 | Oct 25, 2017 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 | TABLET;ORAL | 206500-001 | Sep 1, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Tersera | VARUBI | rolapitant hydrochloride | EMULSION;INTRAVENOUS | 208399-001 | Oct 25, 2017 | ⤷ Try a Trial | ⤷ Try a 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
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 81465
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 08000819
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 36793
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 42459
Estimated Expiration: ⤷ Try a Trial
Patent: 63134
Estimated Expiration: ⤷ Try a Trial
Patent: 41919
Estimated Expiration: ⤷ Try a Trial
Patent: 10522173
Estimated Expiration: ⤷ Try a Trial
Patent: 13216694
Estimated Expiration: ⤷ Try a Trial
Patent: 15108023
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 09010210
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 081891
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 06934
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 50185
Estimated Expiration: ⤷ Try a Trial
Patent: 0902087
Estimated Expiration: ⤷ Try a 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 |
---|---|---|---|
Austria | 386023 | ⤷ Try a Trial | |
Australia | 2002357264 | ⤷ Try a Trial | |
Norway | 20043041 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VARUBI
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1463716 | 300895 | Netherlands | ⤷ Try a 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 | PA2017032 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ROLAPITANTAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS, ISKAITANT ROLAPITANTO HIDROCHLORIDO MONOHIDRATA; REGISTRATION NO/DATE: EU/1/17/1180/001 20170420 |
1463716 | 2017/042 | Ireland | ⤷ Try a Trial | PRODUCT NAME: ROLAPITANT, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING ROLAPITANT HYDROCHLORIDE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/17/1180 20170420 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |