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Last Updated: February 27, 2021

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Rolapitant hydrochloride - Generic Drug Details

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What are the generic sources for rolapitant hydrochloride and what is the scope of freedom to operate?

Rolapitant hydrochloride is the generic ingredient in one branded drug marketed by Tersera and is included in two NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Rolapitant hydrochloride has one hundred and fifty-nine patent family members in thirty-five countries.

Two suppliers are listed for this compound.

Summary for rolapitant hydrochloride
International Patents:159
US Patents:9
Tradenames:1
Applicants:1
NDAs:2
Suppliers / Packagers: 2
Bulk Api Vendors: 19
Clinical Trials: 13
Patent Applications: 5
DailyMed Link:rolapitant hydrochloride at DailyMed
Recent Clinical Trials for rolapitant hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Costantine AlbanyPhase 2
Jacobi Medical CenterPhase 2
Albert Einstein College of Medicine, Inc.Phase 2

See all rolapitant hydrochloride clinical trials

US Patents and Regulatory Information for rolapitant hydrochloride

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 TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Tersera VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes   Start Trial   Start Trial Y 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 Y Y   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 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

Supplementary Protection Certificates for rolapitant hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2004646 2017C/040 Belgium   Start Trial PRODUCT NAME: ROLAPITANT - VARUBY (SOUS FORME DE CHLORHYDRATE MONOHYDRATE); AUTHORISATION NUMBER AND DATE: EU/1/17/1180 20170424
1463716 C201730043 Spain   Start Trial PRODUCT NAME: ROLAPITANT, OPCIONALMENTE EN FORMA DE UNA SAL FARMACEUTICAMENTE ACEPTABLE, INCLUYENDO 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 17C1037 France   Start Trial PRODUCT NAME: ROLAPITANT, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ADMISSIBLE, INCLUANT LE MONOHYDRATE DE CHLORHYDRATE DE ROLAPITANT.; REGISTRATION NO/DATE: EU/1/17/1180 20170424
1463716 609 Finland   Start Trial
1463716 C20170033 00237 Estonia   Start Trial PRODUCT NAME: ROLAPITANT;REG NO/DATE: EU/1/17/1180 24.04.2017
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
2004646 17C1038 France   Start Trial PRODUCT NAME: MONOHYDRATE DE CHLORHYDRATE DE ROLAPITANT; NAT. REGISTRATION NO/DATE: EU/1/17/1180/001 20170424; FIRST REGISTRATION: EU/1/17/1180 20170424
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Harvard Business School
McKesson

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