DrugPatentWatch Database Preview
VARUBI Drug Profile
» See Plans and Pricing
Which patents cover Varubi, and when can generic versions of Varubi launch?
Varubi is a drug marketed by Tersera Theraps Llc 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. Two suppliers are listed for this compound. Additional details are available on the rolapitant hydrochloride profile page.
US ANDA Litigation and 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
Summary for VARUBI
| International Patents: | 159 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 50 |
| Clinical Trials: | 5 |
| Patent Applications: | 37 |
| DailyMed Link: | VARUBI at DailyMed |
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 |
|---|---|
| Costantine Albany | Phase 2 |
| Tesaro, Inc. | Phase 2 |
| Duke University | Phase 2 |
Pharmacology for VARUBI
US Patents and Regulatory Information for VARUBI
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Tersera Theraps Llc | VARUBI | rolapitant hydrochloride | EMULSION;INTRAVENOUS | 208399-001 | Oct 25, 2017 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Tersera Theraps Llc | VARUBI | rolapitant hydrochloride | EMULSION;INTRAVENOUS | 208399-001 | Oct 25, 2017 | DISCN | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Tersera Theraps Llc | VARUBI | rolapitant hydrochloride | EMULSION;INTRAVENOUS | 208399-001 | Oct 25, 2017 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Tersera Theraps Llc | VARUBI | rolapitant hydrochloride | TABLET;ORAL | 206500-001 | Sep 1, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Tersera Theraps Llc | VARUBI | rolapitant hydrochloride | EMULSION;INTRAVENOUS | 208399-001 | Oct 25, 2017 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Tersera Theraps Llc | VARUBI | rolapitant hydrochloride | TABLET;ORAL | 206500-001 | Sep 1, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Tersera Theraps Llc | VARUBI | rolapitant hydrochloride | TABLET;ORAL | 206500-001 | Sep 1, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | 2009010210 | Start Trial |
| Norway | 20084660 | Start Trial |
| Portugal | 1463716 | Start Trial |
| New Zealand | 532975 | Start Trial |
| Singapore | 10201500028R | Start Trial |
| Japan | 2009532473 | Start Trial |
| Brazil | PI0215158 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VARUBI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1463716 | LUC00043 | Luxembourg | Start Trial | PRODUCT NAME: ROLAPITANT, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING ROLAPITANT HYDROCHLORIDE MONOHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1180/001 20170424 |
| 1463716 | 318 50015-2017 | Slovakia | Start Trial | PRODUCT NAME: ROLAPITANT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1180 20170424 |
| 1463716 | 2017C/039 | Belgium | Start Trial | PRODUCT NAME: ROLAPITANT - VARUBY; AUTHORISATION NUMBER AND DATE: EU/1/17/1180 20170424 |
| 2004646 | 132017000117656 | Italy | Start Trial | PRODUCT NAME: ROLAPITANT IDROCLORURO MONOIDRATO(VARUBY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1180/001, 20170424 |
| 1463716 | C 2017 036 | Romania | Start Trial | 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 |
| 2004646 | 300898 | Netherlands | Start Trial | PRODUCT NAME: ROLAPITANT HYDROCHLORIDE-MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/17/1180 20170424 |
| 1463716 | C20170033 00237 | Estonia | Start Trial | PRODUCT NAME: ROLAPITANT;REG NO/DATE: EU/1/17/1180 24.04.2017 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
