Details for New Drug Application (NDA): 209394

NDA 209394 describes MAVYRET, which is a drug marketed by Abbvie and is included in two NDAs. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the MAVYRET profile page.

The generic ingredient in MAVYRET is glecaprevir; pibrentasvir. One supplier is listed for this compound. Additional details are available on the glecaprevir; pibrentasvir profile page.

Summary for 209394

Tradename:	MAVYRET
Applicant:	Abbvie
Ingredient:	glecaprevir; pibrentasvir
Patents:	10

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 209394

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: 209394

Mechanism of Action

Breast Cancer Resistance Protein Inhibitors Cytochrome P450 1A2 Inhibitors Cytochrome P450 3A Inhibitors HCV NS3/4A Protease Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors UGT1A1 Inhibitors

Suppliers and Packaging for NDA: 209394

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394	NDA	AbbVie Inc.	0074-2625	0074-2625-01	1 DOSE PACK in 1 CARTON (0074-2625-01) / 3 TABLET, FILM COATED in 1 DOSE PACK
MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394	NDA	AbbVie Inc.	0074-2625	0074-2625-28	4 CARTON in 1 CARTON (0074-2625-28) / 7 DOSE PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 DOSE PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG;40MG
Approval Date:	Aug 3, 2017	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jun 10, 2028
Regulatory Exclusivity Use:	FOR TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE WEIGHING LESS THAN 45 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS (CHILD-PUGH A); AND TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE WEIGHING LESS THAN 45 KG WITH HCV GENOTYPE 1 INFECTION, WHO PREVIOUSLY HAVE BEEN TREATED WITH A REGIMEN CONTAINING AN HCV NS5A INHIBITOR OR AN NS3/4A PROTEASE INHIBITOR (PI), BUT NOT BOTH
Regulatory Exclusivity Expiration:	Dec 10, 2028
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:	Oct 30, 2026
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY

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