Last Updated: September 28, 2026

Details for New Drug Application (NDA): 022535

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NDA 022535 describes ESBRIET, which is a drug marketed by Legacy and is included in two NDAs. It is available from two suppliers. 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 is one drug master file entry for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the pirfenidone profile page.

Summary for 022535

Tradename:	ESBRIET
Applicant:	Legacy
Ingredient:	pirfenidone
Patents:	19

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

Expired US Patents for NDA 022535

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Legacy	ESBRIET	pirfenidone	CAPSULE;ORAL	022535-001	Oct 15, 2014	7,767,225	⤷ Start Trial
Legacy	ESBRIET	pirfenidone	CAPSULE;ORAL	022535-001	Oct 15, 2014	8,753,679	⤷ Start Trial
Legacy	ESBRIET	pirfenidone	CAPSULE;ORAL	022535-001	Oct 15, 2014	7,988,994	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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