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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Healthtrust
Baxter
Harvard Business School
US Army
Dow
Daiichi Sankyo
Medtronic
Citi

Generated: August 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206500

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NDA 206500 describes VARUBI, which is a drug marketed by Tersera Theraps Llc and is included in two NDAs. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the VARUBI profile page.

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.
Summary for 206500
Tradename:VARUBI
Applicant:Tersera Theraps Llc
Ingredient:rolapitant hydrochloride
Patents:8
Generic Entry Opportunity Date for 206500
Generic Entry Date for 206500*:
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.

Suppliers and Packaging for NDA: 206500
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VARUBI rolapitant hydrochloride TABLET;ORAL 206500 NDA Tesaro, Inc. 69656-101 N 69656-101-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 90MG BASE
Approval Date:Sep 1, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 1, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Dec 8, 2023Product Flag?YSubstance Flag?YDelist Request?
Patented Use:PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY
Patent:➤ Try a Free TrialPatent Expiration:Apr 4, 2027Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Federal Trade Commission
Fuji
Johnson and Johnson
Moodys
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Cantor Fitzgerald
Express Scripts
Deloitte

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