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Last Updated: November 5, 2024

Details for New Drug Application (NDA): 208399


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NDA 208399 describes VARUBI, which is a drug marketed by Tersera and is included in two NDAs. It is available from one supplier. There are eight 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 208399
Tradename:VARUBI
Applicant:Tersera
Ingredient:rolapitant hydrochloride
Patents:6
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208399
Generic Entry Date for 208399*:
Constraining patent/regulatory exclusivity:
Dosage:
EMULSION;INTRAVENOUS

*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.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:EMULSION;INTRAVENOUSStrengthEQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML)
Approval Date:Oct 25, 2017TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Aug 19, 2028Product Flag?YSubstance Flag?YDelist Request?
Patented Use:PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY
Patent:⤷  Sign UpPatent Expiration:Apr 4, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY
Patent:⤷  Sign UpPatent Expiration:Apr 4, 2027Product Flag?YSubstance Flag?YDelist Request?

Expired US Patents for NDA 208399

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Tersera VARUBI rolapitant hydrochloride EMULSION;INTRAVENOUS 208399-001 Oct 25, 2017 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.