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Details for New Drug Application (NDA): 203491

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NDA 203491 describes ILEVRO, which is a drug marketed by Alcon Res Ltd 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. Two suppliers are listed for this compound. Additional details are available on the nepafenac profile page.

Summary for NDA: 203491

Tradename:
ILEVRO
Applicant:
Alcon Res Ltd
Ingredient:
nepafenac
Patents:3
Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 203491

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 Alcon Laboratories, Inc. 0065-1750 0065-1750-07 1 BOTTLE, DROPPER in 1 CARTON (0065-1750-07) > 1.7 mL in 1 BOTTLE, DROPPER
ILEVRO
nepafenac
SUSPENSION/DROPS;OPHTHALMIC 203491 NDA Alcon Laboratories, Inc. 0065-1750 0065-1750-08 1 BOTTLE, DROPPER in 1 CARTON (0065-1750-08) > .8 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.3%
Approval Date:Oct 16, 2012TE:RLD:Yes
Patent:6,403,609Patent Expiration:Jul 17, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:7,947,295Patent Expiration:Jun 8, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:8,921,337Patent Expiration:Mar 31, 2032Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 203491

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alcon Res Ltd
ILEVRO
nepafenac
SUSPENSION/DROPS;OPHTHALMIC203491-001Oct 16, 20125,475,034► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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