Orange Book product · Brand (NDA)

ESBRIET

PIRFENIDONE

Brand (NDA)NDA 022535TE ABRX LEGACY PHARMA

View PIRFENIDONE family Open on FDA Orange Book

At a glance

Oct 15, 2014

Approved

Brand (NDA)

Application

TE code

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Oct 15, 2014
11 yr 10 mo ago
Today
Patent 7767225 expires
Listed drug product patent expiration.
Sep 22, 2026
in 3 mo
Patent 7988994 expires
Listed drug product patent expiration.
Sep 22, 2026
in 3 mo
Patent 8753679 expires
Listed drug product patent expiration.
Sep 22, 2026
in 3 mo
Patent 7696236 expires
Listed method-of-use patent (U-1601) expiration.
Dec 18, 2027
in 1 yr 6 mo
Patent 7767700 expires
Listed method-of-use patent (U-1601) expiration.
Dec 18, 2027
in 1 yr 6 mo
Patent 8420674 expires
Listed drug product patent expiration.
Dec 18, 2027
in 1 yr 6 mo
Patent 8383150 expires
Listed drug product patent expiration.
May 10, 2028
in 1 yr 11 mo
Patent 7566729 expires
Listed method-of-use patent (U-1600) expiration.
Apr 22, 2029
in 2 yr 11 mo
Patent 7635707 expires
Listed method-of-use patent (U-1609) expiration.
Apr 22, 2029
in 2 yr 11 mo
Patent 8592462 expires
Listed method-of-use patent (U-1609) expiration.
Apr 22, 2029
in 2 yr 11 mo
Patent 8609701 expires
Listed method-of-use patent (U-1610) expiration.
Apr 22, 2029
in 2 yr 11 mo
Patent 7816383 expires
Listed method-of-use patent (U-1603) expiration.
Jan 08, 2030
in 3 yr 7 mo
Patent 7910610 expires
Listed method-of-use patent (U-1604) expiration.
Jan 08, 2030
in 3 yr 7 mo
Patent 8013002 expires
Listed method-of-use patent (U-1603) expiration.
Jan 08, 2030
in 3 yr 7 mo
Patent 8084475 expires
Listed method-of-use patent (U-1605) expiration.
Jan 08, 2030
in 3 yr 7 mo
Patent 8318780 expires
Listed method-of-use patent (U-1606) expiration.
Jan 08, 2030
in 3 yr 7 mo
Patent 8648098 expires
Listed method-of-use patent (U-1611) expiration.
Jan 08, 2030
in 3 yr 7 mo
Patent 8754109 expires
Listed method-of-use patent (U-1612) expiration.
Jan 08, 2030
in 3 yr 7 mo
Patent 8778947 expires
Listed method-of-use patent (U-1613) expiration.
Aug 30, 2033
in 7 yr 4 mo

Pharmaceutical detail

Active ingredient

PIRFENIDONE

Strength

267MG

Dosage form

CAPSULE

Route

ORAL

TE code

Application

NDA 022535

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents (19)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7767225	Sep 22, 2026	in 3 mo	ProductU-1602
7988994	Sep 22, 2026	in 3 mo	ProductU-1602
8753679	Sep 22, 2026	in 3 mo	ProductU-1602
7696236	Dec 18, 2027	in 1 yr 6 mo	U-1601
7767700	Dec 18, 2027	in 1 yr 6 mo	U-1601
8420674	Dec 18, 2027	in 1 yr 6 mo	ProductU-1608
8383150	May 10, 2028	in 1 yr 11 mo	ProductU-2361
7566729	Apr 22, 2029	in 2 yr 11 mo	U-1600
7635707	Apr 22, 2029	in 2 yr 11 mo	U-1609
8592462	Apr 22, 2029	in 2 yr 11 mo	U-1609
8609701	Apr 22, 2029	in 2 yr 11 mo	U-1610
7816383	Jan 08, 2030	in 3 yr 7 mo	U-1603
7910610	Jan 08, 2030	in 3 yr 7 mo	U-1604
8013002	Jan 08, 2030	in 3 yr 7 mo	U-1603
8084475	Jan 08, 2030	in 3 yr 7 mo	U-1605
8318780	Jan 08, 2030	in 3 yr 7 mo	U-1606
8648098	Jan 08, 2030	in 3 yr 7 mo	U-1611
8754109	Jan 08, 2030	in 3 yr 7 mo	U-1612
8778947	Aug 30, 2033	in 7 yr 4 mo	U-1613

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