➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Johnson and Johnson

Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206500

Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

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

The generic ingredient in VARUBI is rolapitant hydrochloride. Two suppliers are listed for this compound. Additional details are available on the rolapitant hydrochloride profile page.
Summary for 206500
Applicant:Tersera Theraps Llc
Ingredient:rolapitant hydrochloride
Generic Entry Opportunity Date for 206500
Generic Entry Date for 206500*:
Constraining patent/regulatory exclusivity:

*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 69656-101-02 2 TABLET in 1 BLISTER PACK (69656-101-02)
VARUBI rolapitant hydrochloride TABLET;ORAL 206500 NDA TerSera Therapeutics LLC 70720-101 70720-101-02 2 TABLET in 1 BLISTER PACK (70720-101-02)

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:  Start TrialPatent Expiration:Dec 8, 2023Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Apr 4, 2027Product Flag?YSubstance Flag?Delist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson

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.