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Last Updated: November 30, 2022

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.

One supplier is listed for this compound.

Summary for rolapitant hydrochloride
Recent Clinical Trials for rolapitant hydrochloride

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

SponsorPhase
PlusVitech S.L.Phase 2
ECONiX Araştırma Analiz ve Danışmanlık A.Ş.Phase 2
Albert Einstein College of MedicinePhase 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 See Plans and Pricing See Plans and Pricing 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 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 EMULSION;INTRAVENOUS 208399-001 Oct 25, 2017 DISCN Yes No See Plans and Pricing See Plans and Pricing 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

Supplementary Protection Certificates for rolapitant hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
2004646 2017C/040 Belgium See Plans and Pricing PRODUCT NAME: ROLAPITANT - VARUBY (SOUS FORME DE CHLORHYDRATE MONOHYDRATE); AUTHORISATION NUMBER AND DATE: EU/1/17/1180 20170424
2004646 122017000079 Germany See Plans and Pricing PRODUCT NAME: ROLAPITANT HYDROCHLORID-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1180 20170420
2004646 PA2017031 Lithuania See Plans and Pricing PRODUCT NAME: ROLAPITANTO HIDROCHLORIDO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/17/1180/001 20170420
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
McKesson

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