Orange Book product · Brand (NDA)

ILEVRO

NEPAFENAC

Brand (NDA)NDA 203491RX HARROW EYE

Oct 16, 2012

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 16, 2012
13 yr 10 mo ago
Today
Patent 9662398 expires
Listed drug product patent expiration.
Dec 01, 2030
in 4 yr 6 mo
Patent 8921337 expires
Listed drug product patent expiration.
Mar 31, 2032
in 5 yr 10 mo

Active ingredient

NEPAFENAC

Strength

0.3%

Dosage form

SUSPENSION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 203491

Product number

001

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
9662398	Dec 01, 2030	in 4 yr 6 mo	Product
8921337	Mar 31, 2032	in 5 yr 10 mo	Product