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Last Updated: November 5, 2024

Rolapitant hydrochloride - Generic Drug Details


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What are the generic drug sources for rolapitant hydrochloride and what is the scope of patent protection?

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

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

One supplier is listed for this compound.

Summary for rolapitant hydrochloride
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for rolapitant hydrochloride
Generic Entry Dates for rolapitant hydrochloride*:
Constraining patent/regulatory exclusivity:
Dosage:
EMULSION;INTRAVENOUS
Generic Entry Dates for rolapitant hydrochloride*:
Constraining patent/regulatory exclusivity:
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 rolapitant hydrochloride

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

SponsorPhase
Guangxi Medical UniversityPhase 3
PlusVitech S.L.Phase 2
ECONiX Araştırma Analiz ve Danışmanlık A.Ş.Phase 2

See all rolapitant hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for rolapitant hydrochloride

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 EMULSION;INTRAVENOUS 208399-001 Oct 25, 2017 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Tersera VARUBI rolapitant hydrochloride EMULSION;INTRAVENOUS 208399-001 Oct 25, 2017 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Tersera VARUBI rolapitant hydrochloride EMULSION;INTRAVENOUS 208399-001 Oct 25, 2017 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Tersera VARUBI rolapitant hydrochloride EMULSION;INTRAVENOUS 208399-001 Oct 25, 2017 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Tersera VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 rolapitant hydrochloride

Country Patent Number Title Estimated Expiration
China 103751186 Pharmaceutical formulations: salts of 8-[1-3,5-bis-(trifluoromethyl)phenyl)-ethoxymethyl]-8-phenyl-1,7-diaza-spiro[4.5]decan-2-one and treatment methods using the same ⤷  Sign Up
Hungary E028908 ⤷  Sign Up
Brazil PI0710577 formulações farmacêuticas: sais de 8-[{1-(3,5-bis-(trifluorometil)fenil)-etóxi-metil]-8-fenil- 1,7-diaza-espiro[4.5]decan-2-ona e métodos de tratamento usando-se as mesmas ⤷  Sign Up
Spain 2406934 ⤷  Sign Up
Spain 2372871 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for rolapitant hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1463716 132017000117643 Italy ⤷  Sign Up PRODUCT NAME: ROLAPITANT, OPZIONALMENTE NELLA FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE, INCLUSO ROLAPITANT IDROCLORURO MONOIDRATO(VARUBY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1180/001, 20170424
2004646 PA2017031 Lithuania ⤷  Sign Up PRODUCT NAME: ROLAPITANTO HIDROCHLORIDO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/17/1180/001 20170420
1463716 300895 Netherlands ⤷  Sign Up 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 46/2017 Austria ⤷  Sign Up 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 122017000079 Germany ⤷  Sign Up PRODUCT NAME: ROLAPITANT HYDROCHLORID-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1180 20170420
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.