Nepafenac
As of the edition of 20 October 2026, Nepafenac is a small molecule: marketed, first approved in 2005 (US); acts on PTGS1 and PTGS2; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2013
- Kind
- Small molecule
- Brand name
- Nevanac
- First approved
- 19 August 2005 (US)
- Approvals on record
- 7 in 5 regions
- Holder of the most recent approval
- NOVARTIS BIOCIENCIAS S.A; 5 holders in all
- Registered trials
- 30, 3 stopped early
- Disease areas
- Eye; Hormones; Heart and blood vessels; Immune system; Nervous system; Nutrition and metabolism
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Companies that need a new molecule because of this drug
5 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product5 company-target rows are on route B because of Nepafenac.
See the 5 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 2 | 0 | 0 |
| Phase 2 | 4 | 2 | 0 | 1 |
| Phase 3 | 9 | 8 | 0 | 1 |
| Phase 4 | 14 | 11 | 1 | 1 |
| All trials | 30 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Alcon | Originator and Lead sponsor of trials | 2005 to now |
| Novartis | Applicant | 2007 to now |
| Harrow Eye | Acquired holder | 2023 to now |