FDA Orange Book · active-ingredient family
Nepafenac
Nepafenac: 2 brands, 0 generics; first approved Aug 19, 2005; on patent until Jan 31, 2027.
On patent
Generic status & protection
Protected until Jan 31, 2027 (earliest listed patent expiry).
Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
0
Listed patents
3
Next patent expiry
Jan 31, 2027
in 5 mo
Brand (NDA) products
Originator applications
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7834059 | in 5 mo | U-1095 | |
| 9662398 | in 4 yr 4 mo | Product | |
| 8921337 | in 5 yr 8 mo | Product |
Approval history
FDA approval span
First approval
21 yr 4 mo ago
Most recent approval
14 yr 1 mo ago
Approvals span 2005–2012 across 2 FDA applications.
Brand (NDA) 2100%
Generic (ANDA) 00%
Nepafenac: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
