Details for New Drug Application (NDA): 212887

NDA 212887 describes VOCABRIA, which is a drug marketed by Viiv Hlthcare and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the VOCABRIA profile page.

The generic ingredient in VOCABRIA is cabotegravir sodium. One supplier is listed for this compound. Additional details are available on the cabotegravir sodium profile page.

Summary for 212887

Tradename:	VOCABRIA
Applicant:	Viiv Hlthcare
Ingredient:	cabotegravir sodium
Patents:	2

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 212887

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: 212887

Mechanism of Action

HIV Integrase Inhibitors Organic Anion Transporter 1 Inhibitors Organic Anion Transporter 3 Inhibitors

Suppliers and Packaging for NDA: 212887

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VOCABRIA	cabotegravir sodium	TABLET;ORAL	212887	NDA	ViiV Healthcare Company	49702-248	49702-248-13	30 TABLET, FILM COATED in 1 BOTTLE (49702-248-13)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 30MG BASE
Approval Date:	Jan 21, 2021	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jan 21, 2026
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:	Mar 29, 2025
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:	Jan 31, 2025
Regulatory Exclusivity Use:	REVISION TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY 207966 ATLAS-2M

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