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Last Updated: December 4, 2025

Details for New Drug Application (NDA): 203491

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NDA 203491 describes ILEVRO, which is a drug marketed by Harrow Eye and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ILEVRO profile page.

The generic ingredient in ILEVRO is nepafenac. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nepafenac profile page.

Summary for 203491

Tradename:	ILEVRO
Applicant:	Harrow Eye
Ingredient:	nepafenac
Patents:	2

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 203491

Generic Entry Date for 203491^: ⤷ Get Started Free* Constraining patent/regulatory exclusivity: 9,662,398 Dosage: SUSPENSION/DROPS;OPHTHALMIC

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 203491

Mechanism of Action	Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 203491

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491	NDA	Harrow Eye, LLC	82667-400	82667-400-03	1 BOTTLE, PLASTIC in 1 CARTON (82667-400-03) / 3 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION/DROPS;OPHTHALMIC			Strength	0.3%
Approval Date:	Oct 16, 2012	TE:		RLD:	Yes
Patent:	8,921,337	Patent Expiration:	Mar 31, 2032	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	9,662,398	Patent Expiration:	Dec 1, 2030	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 203491

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012	5,475,034	⤷ Get Started Free
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012	7,947,295	⤷ Get Started Free
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012	6,403,609	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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