Details for New Drug Application (NDA): 208780

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NDA 208780 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 208780

Tradename:	ESBRIET
Applicant:	Genentech Inc
Ingredient:	pirfenidone
Patents:	16

Pharmacology for NDA: 208780

Suppliers and Packaging for NDA: 208780

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ESBRIET	pirfenidone	TABLET;ORAL	208780	NDA	Genentech, Inc.	50242-122	50242-122-06	1 BOTTLE, PLASTIC in 1 CARTON (50242-122-06) / 270 TABLET, COATED in 1 BOTTLE, PLASTIC
ESBRIET	pirfenidone	TABLET;ORAL	208780	NDA	Genentech, Inc.	50242-122	50242-122-86	1 BOTTLE, PLASTIC in 1 CARTON (50242-122-86) / 189 TABLET, COATED in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	267MG
Approval Date:	Jan 11, 2017	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Mar 28, 2037	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Apr 22, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400 MG/DAY DOSE THEN FULL DAY DAILY DOSE IN TREATMENT OF IPF
Patent:	⤷ Sign Up	Patent Expiration:	Apr 22, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN LIMITS, THEN SUB-2400MG/DAY DOSE, THEN FULL DAILY DOSE IN TREATMENT OF IPF

Expired US Patents for NDA 208780

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	⤷ Sign Up	⤷ Sign Up
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	⤷ Sign Up	⤷ Sign Up
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-002	Jan 11, 2017	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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