FDA Orange Book · active-ingredient family
Nepafenac
Nepafenac is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ILEVRO · NDA 203491
2
Brand (NDA)
0
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ILEVRORLD | HARROW EYE | NDA 203491 | — | Oct 16, 2012 | |
| NEVANACRLD | HARROW EYE | NDA 021862 | — | Aug 19, 2005 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7834059 | Jan 31, 2027 | in 8 mo | U-1095 |
| 9662398 | Dec 01, 2030 | in 4 yr 6 mo | Product |
| 8921337 | Mar 31, 2032 | in 5 yr 10 mo | Product |
Nepafenac — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
