NEVANAC
LOE Approachingnepafenac
NDAOPHTHALMICSUSPENSION/DROPSPriority Review
Approved
Aug 2005
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
NEVANAC (nepafenac) is cyclooxygenase inhibitors [moa]. First approved in 2005.
Drug data last refreshed 8h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NEVANAC (nepafenac) is a topical ophthalmic nonsteroidal anti-inflammatory drug (NSAID) suspension approved in 2005 for ocular inflammation and pain management. It works by inhibiting cyclooxygenase enzymes to reduce prostaglandin-mediated inflammation in the eye. The drug is administered as eye drops and targets patients undergoing cataract surgery or those with post-operative ocular inflammation.
$0.080MPart D
LOE Approaching3mo to LOEWith loss of exclusivity approaching in January 2027 and minimal Part D claims (213 in 2023), this product is in late-stage decline with expected downsizing of brand-focused teams.
Mechanism of Action
Cyclooxygenase Inhibitors
Pharmacologic Class:
Nonsteroidal Anti-inflammatory Drug
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Tolerability and Toxicity of Topically Applied Nepafenac 0.3% vs Ketorolac 0.5%
Started Apr 2016
200 enrolled
Cataract
Study Title: Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevro (Nepafenac Ophthalmic Suspension) 0.3% QD With Extra (Pulse) Dose on Day of Surgery for Treatment of Ocular Inflammation Associated With Cataract Surgery in a Randomized, Single Masked Clinical Trial
Started Oct 2013
57 enrolled
Treatment of Ocular Inflammation Associated With Cataract Surgery
Nepafenac Once Daily for Macular Edema - Study 1
Started Jun 2013
881 enrolled
Non-Proliferative Diabetic RetinopathyCataract
Nepafenac Once Daily for Macular Edema - Study 2
Started Jun 2013
819 enrolled
Non-Proliferative Diabetic RetinopathyCataract
Prolensa (Bromfenac) 0.07% QD vs. Ilevro (Nepafenac) 0.3% QD for Treatment of Ocular Inflammation Post Cataract Surgery
Started Apr 2013
50 enrolled
CataractRetinal EdemaInflammation
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.