Details for New Drug Application (NDA): 022535

NDA 022535 describes ESBRIET, which is a drug marketed by Genentech Inc and is included in two NDAs. It is available from one supplier. There are twenty patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ESBRIET profile page.

The generic ingredient in ESBRIET is pirfenidone. There are twenty-three drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the pirfenidone profile page.

Summary for 022535

Tradename:	ESBRIET
Applicant:	Genentech Inc
Ingredient:	pirfenidone
Patents:	19

Pharmacology for NDA: 022535

Suppliers and Packaging for NDA: 022535

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ESBRIET	pirfenidone	CAPSULE;ORAL	022535	NDA	Genentech, Inc.	50242-121	50242-121-01	1 BOTTLE, PLASTIC in 1 CARTON (50242-121-01) / 270 CAPSULE in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	267MG
Approval Date:	Oct 15, 2014	TE:	AB	RLD:	Yes
Patent:	7,566,729	Patent Expiration:	Apr 22, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
Patent:	7,635,707	Patent Expiration:	Apr 22, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
Patent:	7,696,236	Patent Expiration:	Dec 18, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS

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