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Serving leading biopharmaceutical companies globally:

McKinsey
Express Scripts
Moodys
Johnson and Johnson
Queensland Health
Chinese Patent Office
Teva
Deloitte
AstraZeneca
QuintilesIMS

Generated: February 25, 2018

DrugPatentWatch Database Preview

Rolapitant hydrochloride - Generic Drug Details

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

Rolapitant hydrochloride
is the generic ingredient in one branded drug marketed by Tesaro Inc 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-one patent family members in thirty-four countries.

One supplier is listed for this compound.
Summary for rolapitant hydrochloride
International Patents:151
US Patents:9
Tradenames:1
Applicants:1
NDAs:2
Suppliers / Packagers: 1
Bulk Api Vendors: 25
Clinical Trials: 12
Patent Applications: 40
Drug Prices:see low prices
DailyMed Link:rolapitant hydrochloride at DailyMed

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
Tesaro Inc VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Tesaro Inc VARUBI rolapitant hydrochloride EMULSION;IV (INFUSION) 208399-001 Oct 25, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Tesaro Inc VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Tesaro Inc VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Tesaro Inc VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Tesaro Inc VARUBI rolapitant hydrochloride EMULSION;IV (INFUSION) 208399-001 Oct 25, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Tesaro Inc VARUBI rolapitant hydrochloride EMULSION;IV (INFUSION) 208399-001 Oct 25, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Tesaro Inc VARUBI rolapitant hydrochloride EMULSION;IV (INFUSION) 208399-001 Oct 25, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Tesaro Inc VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Tesaro Inc VARUBI rolapitant hydrochloride EMULSION;IV (INFUSION) 208399-001 Oct 25, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 rolapitant hydrochloride

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
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 ➤ Sign Up
8,273,895 NK.sub.1 antagonists ➤ Sign Up
9,688,693 NK.sub.1 antagonists ➤ Sign Up
7,902,366 NK.sub.1 antagonists ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for rolapitant hydrochloride

Supplementary Protection Certificates for rolapitant hydrochloride

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

Fish and Richardson
Healthtrust
McKinsey
Accenture
Cerilliant
Cantor Fitzgerald
Boehringer Ingelheim
US Army
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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