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Last Updated: March 19, 2024

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 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

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 ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Tersera VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Tersera VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Tersera VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Tersera VARUBI rolapitant hydrochloride EMULSION;INTRAVENOUS 208399-001 Oct 25, 2017 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Tersera VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Tersera VARUBI rolapitant hydrochloride EMULSION;INTRAVENOUS 208399-001 Oct 25, 2017 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for rolapitant hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Tersera VARUBI rolapitant hydrochloride EMULSION;INTRAVENOUS 208399-001 Oct 25, 2017 ⤷  Try a Trial ⤷  Try a Trial
Tersera VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for rolapitant hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1463716 1790044-0 Sweden ⤷  Try a Trial PRODUCT NAME: ROLAPITANT, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING ROLAPITANT HYDROCHLORIDE MONOHYDRATE; REG. NO/DATE: EU/1/17/1180/001 20170424
1463716 2017C/039 Belgium ⤷  Try a Trial PRODUCT NAME: ROLAPITANT - VARUBY; AUTHORISATION NUMBER AND DATE: EU/1/17/1180 20170424
1463716 17C1037 France ⤷  Try a 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 LUC00043 Luxembourg ⤷  Try a 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 C20170033 00237 Estonia ⤷  Try a Trial PRODUCT NAME: ROLAPITANT;REG NO/DATE: EU/1/17/1180 24.04.2017
2004646 PA2017031 Lithuania ⤷  Try a Trial PRODUCT NAME: ROLAPITANTO HIDROCHLORIDO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/17/1180/001 20170420
1463716 609 Finland ⤷  Try a Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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