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Serving leading biopharmaceutical companies globally:

US Department of Justice
US Army
Cipla
Harvard Business School
Daiichi Sankyo
Covington
Teva
AstraZeneca
Colorcon
Argus Health

Generated: January 20, 2018

DrugPatentWatch Database Preview

VARUBI Drug Profile

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When do Varubi patents expire, and when can generic versions of Varubi launch?

Varubi is a drug marketed by Tesaro Inc and is included in two NDAs. There are eight patents protecting this drug.

This drug has one hundred and twenty-eight patent family members in thirty-four countries.

The generic ingredient in VARUBI is rolapitant hydrochloride. One supplier is listed for this compound. Additional details are available on the rolapitant hydrochloride profile page.

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
Tesaro Inc VARUBI rolapitant hydrochloride EMULSION;IV (INFUSION) 208399-001 Oct 25, 2017 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Tesaro Inc VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Tesaro Inc VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Tesaro Inc VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Tesaro Inc VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Tesaro Inc VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Tesaro Inc VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Tesaro Inc VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Tesaro Inc VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Tesaro Inc VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for VARUBI

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,902,366 NK.sub.1 antagonists ➤ Subscribe
8,273,895 NK.sub.1 antagonists ➤ Subscribe
9,345,692 Pharmaceutical formulations: salts of 8-[1-3,5-bis-(trifluoromethyl)phenyl)-ethoxy-methyl]-8-phenyl-1,7-diaza-s- piro[4.5]decan-2-one and treatment methods using the same ➤ Subscribe
9,688,693 NK.sub.1 antagonists ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for VARUBI

Supplementary Protection Certificates for VARUBI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0895 Netherlands ➤ Subscribe 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
2017031 Lithuania ➤ Subscribe PRODUCT NAME: ROLAPITANTO HIDROCHLORIDO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/17/1180/001 20170420
2017032 Lithuania ➤ Subscribe PRODUCT NAME: ROLAPITANTAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS, ISKAITANT ROLAPITANTO HIDROCHLORIDO MONOHIDRATA; REGISTRATION NO/DATE: EU/1/17/1180/001 20170420
2017 00041 Denmark ➤ Subscribe PRODUCT NAME: ROLAPITANT, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, INKLUSIV ROLAPITANT-HYDROCHLORID-MONOHYDRAT; REG. NO/DATE: EU/1/17/1180 20170424
0898 Netherlands ➤ Subscribe PRODUCT NAME: ROLAPITANT HYDROCHLORIDE-MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/17/1180 20170424
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Deloitte
Queensland Health
Dow
Merck
Cipla
Johnson and Johnson
Mallinckrodt
Fish and Richardson
Teva

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 verifification 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.

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