`
`Active Ingredient:
`
`Dosage Form;Route:
`
`Proprietary Name:
`
`Applicant:
`
`Strength:
`
`Application Number:
`
`Product Number:
`
`Approval Date:
`
`Reference Listed Drug
`
`RX/OTC/DISCN:
`
`TE Code:
`
`NEPAFENAC
`
`SUSPENSION/DROPS;OPHTHALMIC
`
`NEVANAC
`ALCON PHARMS LTD
`
`0.1%
`
`N021862
`
`001
`Aug 19, 2005
`
`Yes
`
`RX
`
`Patent and Exclusivity Info for this product: View
`
`Return to Electronic Orange Book Home Page6
`
`FDA/Center for Drug Evaluation and Research
`Office of Generic Drugs
`Division of Labeling and Program Support
`Update Frequency:
`Orange Book Data - Monthly
`Generic Drug Product Information & Patent Information - Daily
`Orange Book Data Updated Through February 2015
`Patent and Generic Drug Product Data Last Updated April 06, 2015
`
`Links on this page:
`
`1. http://www.addthis.com/bookmark.php?
`u508=true&v=152&username=fdamain
`
`2. http://www.addthis.com/bookmark.php
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`3. http://www.fda.gov/default.htm
`
`4. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`
`5.
`
`../default.cfm
`
`6.
`
`../default.cfm
`
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`Downloading Viewers and Players.
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`Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency
`Website Policies
`
`
`
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`Ph. 1-888-INFO-FDA (1-888-463-6332)
`Email FDA
`
`For Government For Press
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`Professionals FDA Archive
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`
`
`Patent and Exclusivity Search Results from query on Appl No 021862 Product 001 in the OB_Rx list.
`
`Patent Data
`
`Appl No
`
`Prod No
`
`Patent No
`
`Patent
`Expiration
`
`Drug Substance
`Claim
`
`Drug Product
`Claim
`
`Patent Use
`Code
`
`Delist
`Requested
`
`N021862
`
`N021862
`
`N021862
`
`001
`
`001
`
`001
`
`7834059
`
`8071648
`
`8324281
`
`Jan 31, 2027
`
`Dec 2, 2025
`
`Dec 2, 2025
`
`U - 1095
`
`Y
`
`Y
`
`Exclusivity Data
`
`There is no unexpired exclusivity for this product.
`
`Additional information:
`
`1. Patents are published upon receipt by the Orange Book Staff and may not reflect the official receipt date as described in 21 CFR 314.53(d)(5).
`
`2. Patents listed prior to August 18, 2003 are flagged with method of use claims only as applicable and submitted by the sponsor. These patents may not be
`flagged with respect to other claims which may apply.
`
`View a list of all patent use codes
`View a list of all exclusivity codes
`Return to Electronic Orange Book Home Page6
`
`FDA/Center for Drug Evaluation and Research
`Office of Generic Drugs
`Division of Labeling and Program Support
`Update Frequency:
`
`Orange Book Data - Monthly
`Generic Drug Product Information & Patent Information - Daily
`Orange Book Data Updated Through February 2015
`Patent and Generic Drug Product Data Last Updated April 06, 2015
`
`Links on this page:
`
`1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
`
`2. http://www.addthis.com/bookmark.php
`
`3. http://www.fda.gov/default.htm
`
`4. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`
`5.
`
`6.
`
`../default.cfm
`
`../default.cfm
`
`Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
`
`Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency Website Policies
`
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`Ph. 1-888-INFO-FDA (1-888-463-6332)
`Email FDA
`
`For Government For Press
`
`Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News &
`Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive
`
`