Orange Book product · Brand (NDA)

OFEV

NINTEDANIB ESYLATE

Brand (NDA)NDA 205832TE ABRX BOEHRINGER INGELHEIM

Oct 15, 2014

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 15, 2014
11 yr 10 mo ago
Patent 6762180 expires
Listed drug substance patent expiration.
Oct 01, 2025
9 mo ago
Patent 10154990 expires
Listed method-of-use patent (U-2620) expiration.
Jan 08, 2026
5 mo ago
Patent 6762180*PED expires
Listed listed patent expiration.
Apr 01, 2026
3 mo ago
Today
Patent 10154990*PED expires
Listed listed patent expiration.
Jul 08, 2026
in 19 d
Exclusivity ends · ODE-261
Orphan-drug exclusivity (7 years)
Sep 06, 2026
in 3 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Mar 06, 2027
in 9 mo
Patent 10105323 expires
Listed drug product patent expiration.
Jun 04, 2029
in 3 yr
Patent 9907756 expires
Listed drug product patent expiration.
Jun 07, 2029
in 3 yr
Patent 10105323*PED expires
Listed listed patent expiration.
Dec 04, 2029
in 3 yr 6 mo
Patent 9907756*PED expires
Listed listed patent expiration.
Dec 07, 2029
in 3 yr 6 mo

Active ingredient

NINTEDANIB ESYLATE

Strength

EQ 150MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Application

NDA 205832

Product number

002

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

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

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
6762180	Oct 01, 2025	9 mo ago	SubstanceProduct
10154990	Jan 08, 2026	5 mo ago	U-2620
6762180*PED	Apr 01, 2026	3 mo ago
10154990*PED	Jul 08, 2026	in 19 d
10105323	Jun 04, 2029	in 3 yr	Product
9907756	Jun 07, 2029	in 3 yr	Product
10105323*PED	Dec 04, 2029	in 3 yr 6 mo
9907756*PED	Dec 07, 2029	in 3 yr 6 mo