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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Ilevro (2023)

Total Spending

$20.4M

Total Claims

49,908

Beneficiaries

28,476

Avg Cost/Unit

$127.94

Spending Trend

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

YoY Change:+12.3%

5yr CAGR:+10.1%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain7 active DMFs

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

CARBOGEN AMCIS AGNEPAFENAC

DMF 178122004

CURIA WISCONSIN INCNEPAFENAC DRUG SUBSTANCE

DMF 226362009

ALP PHARM BEIJING CO LTDNEPAFENAC

DMF 230322009

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	—	—