Last Updated: September 28, 2026

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 two suppliers. There are eight patents protecting this drug. Additional details are available on the VARUBI profile page.

The generic ingredient in VARUBI is rolapitant hydrochloride. There is one drug master file entry for this compound. Two suppliers are 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^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: ⤷ Start Trial 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:	DISCN	Dosage:	EMULSION;INTRAVENOUS			Strength	EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML)
Approval Date:	Oct 25, 2017	TE:		RLD:	Yes
Patent:	⤷ Start Trial	Patent Expiration:	Aug 19, 2028	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY
Patent:	⤷ Start Trial	Patent Expiration:	Apr 4, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY
Patent:	⤷ Start Trial	Patent Expiration:	Apr 4, 2027	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 208399

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Tersera	VARUBI	rolapitant hydrochloride	EMULSION;INTRAVENOUS	208399-001	Oct 25, 2017	⤷ Start Trial	⤷ Start Trial
>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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.

Summary for 208399

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208399

Profile for product number 001

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DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 208399