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Last Updated: March 28, 2024

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 three 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:3
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203491
Generic Entry Date for 203491*:
Constraining patent/regulatory exclusivity:
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 ActionCyclooxygenase 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 Novartis Pharmaceuticals Corporation 0078-0743 0078-0743-03 1 BOTTLE in 1 CARTON (0078-0743-03) / 3 mL in 1 BOTTLE
ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491 NDA Novartis Pharmaceuticals Corporation 0078-0743 0078-0743-96 1 BOTTLE in 1 CARTON (0078-0743-96) / .8 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.3%
Approval Date:Oct 16, 2012TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Jun 8, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Mar 31, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Dec 1, 2030Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 203491

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Harrow Eye ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 ⤷  Try a Trial ⤷  Try a Trial
Harrow Eye ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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