Viewing data from:

ILEVRO

NDA

NEPAFENAC | N203491 | HARROW EYE LLC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

2030

2031

2032

Today

8921337

Mar. 31, 2032

9662398

Dec. 1, 2030

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Alcon Research, Ltd. v. Watson Laboratories, Inc. 1:2016cv00129 2 patentsANDA 208816nepafenac	D. Del.	2016-03-04	Terminated 2018-09-28	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

46 trials from ClinicalTrials.gov, 38 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Safety/Efficacy of Nepafenac Punctal Plug Delivery System Compared to Placebo to Control Ocular Pain/Inflammation After Cataract NCT03496467	Phase 2	Completed	Mati Therapeutics Inc.	56	2018-03-05 → 2018-12-17
Confirmatory Study Nepafenac 0.3%NCT01109173	Phase 3	Completed	Alcon Research	2,120	2010-06
Prolensa (Bromfenac) 0.07% QD vs. Ilevro (Nepafenac) 0.3% QD for Treatment of Ocular Inflammation Post Cataract Surgery NCT01847638	N/A	Completed	Melissa Toyos	50	2013-04-01 → 2018-08-23
A Comparison of Topical Nepafenac to Placebo in Corneal Epithelial Healing Times and Postoperative Pain Relief NCT00330798	Phase 4	Completed	Alcon Research	40	2006-02 → 2006-06
Prophylactic Nepafenac and Ketorolac Versus Placebo in Patients Undergoing Cataract Surgery NCT01395069	Phase 4	Completed	Queen's University	162	2010-02 → 2011-05
Anti-inflammatory Efficacy for Prophylaxis of Cystoid Macular Edema (CME) After Phacoemulsification NCT02084576	Phase 4	Completed	Hospital Oftalmologico de Brasilia	40	2013-08 → 2014-02
Topical Nepafenac as Supplement for Diabetic Macular Edema NCT02443012	Phase 4	Completed	Universiti Sains Malaysia	47	2013-03 → 2014-08
Dropless vs. Standard Drops Contralateral Eye Study NCT02515045	Phase 4	Completed	Carolina Eyecare Physicians, LLC	59	2015-01 → 2016-03
Role of Nepafenac in Reducing Macular Volume After Epiretinal Membrane Surgery NCT00818844	Phase 4	Completed	Alcon Research	40	2009-01 → 2010-06
Acular LS vs. Nevanac in Post op Inflammation Following Cataract Surgery NCT00348582	Phase 4	Completed	Innovative Medical	—	—

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$121.12

per ml

Lowest NADAC/Unit

$121.12

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
82667040003ILEVRO 0.3% OPHTH DROPS	$121.12	ML	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$244.47

Highest Price

$244.47

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
82667-0400-03ILEVRO 0.3% SUSP,OPH	$244.47	FSS	Harrow Eye, LLC	03/14/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Ilevro (2024)

Total Spending

$14.9M

Total Claims

37,389

Beneficiaries

21,018

Avg Cost/Unit

$122.67

Spending Trend

$16.3M(2021)→$20.0M(2022)→$20.4M(2023)→$14.9M(2024)

YoY Change:-4.1%

5yr CAGR:+5.1%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain9 active DMFs

7 active API suppliers hold Drug Master Files for this ingredient.

CARBOGEN AMCIS AGNEPAFENAC

DMF 178122004

SIEGFRIED GRAFTON INCNEPAFENAC DRUG SUBSTANCE

DMF 226362009

ALP PHARM BEIJING CO LTDNEPAFENAC

DMF 230322009

CHEMWERTH INCNEPAFENAC, NON-STERILE BULK DRUG SUBSTANCE

DMF 255282014

CHEMWERTH INCNEPAFENAC, STERILE BULK DRUG SUBSTANCE

DMF 282052015

MEDICHEM SANEPAFENAC

DMF 284322014

MATRIX PHARMACORP PRIVATE LTDNEPAFENAC

DMF 305932016

MATRIX PHARMACORP PRIVATE LTDNEPAFENAC (STERILE)

DMF 305942016

FDC LTDNEPAFENAC

DMF 406182024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jul 8, 2014	SUPPL -6	View Letter (PDF)
Dec 19, 2012	SUPPL -1	View Letter (PDF)
Oct 18, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.3%

RLD

2 patents0 exclusivities▴

SUSPENSION/DROPS;OPHTHALMIC | Approved: Oct 16, 2012

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8921337	Mar 31, 2032	—	—	Yes	—	—
9662398	Dec 1, 2030	—	—	Yes	—	—