➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Express Scripts
Mallinckrodt
Moodys
McKinsey
AstraZeneca
McKesson

Last Updated: October 23, 2020

DrugPatentWatch Database Preview

VARUBI Drug Profile

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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

< Available with Subscription >

  Start Trial

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
Drug patent expirations by year for VARUBI
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

SponsorPhase
Costantine AlbanyPhase 2
Tesaro, Inc.Phase 2
Duke UniversityPhase 2

See all VARUBI clinical trials

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

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Merck
Colorcon
Moodys
Medtronic

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. 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.