Details for New Drug Application (NDA): 206500

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NDA 206500 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 206500

Tradename:	VARUBI
Applicant:	Tersera
Ingredient:	rolapitant hydrochloride
Patents:	7

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 206500

Generic Entry Date for 206500^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 8,361,500 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.

Pharmacology for NDA: 206500

Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2D6 Inhibitors Neurokinin 1 Antagonists P-Glycoprotein Inhibitors

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	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:	RX	Dosage:	TABLET;ORAL			Strength	EQ 90MG BASE
Approval Date:	Sep 1, 2015	TE:		RLD:	Yes
Patent:	7,049,320	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:	7,563,801	Patent Expiration:	Apr 4, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	7,981,905	Patent Expiration:	Apr 4, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY

Expired US Patents for NDA 206500

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Tersera	VARUBI	rolapitant hydrochloride	TABLET;ORAL	206500-001	Sep 1, 2015	8,796,299	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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