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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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`FDA Home3 Drug Databases4 Orange Book5
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`Patent and Exclusivity Search Results from query on Appl No 203168 Product 001 in the list.
`
`Patent Data
`
`Appl No
`
`Prod No
`
`Patent No
`
`N203168
`N203168
`N203168
`N203168
`N203168
`N203168
`N203168
`N203168
`
`001
`001
`001
`001
`001
`001
`001
`001
`
`Exclusivity Data
`
`8129431
`8669290
`8754131
`8871813
`8927606
`8927606
`8927606
`9144609
`
`Patent
`Expiration
`Sep 11, 2025
`Jan 16, 2024
`Jan 16, 2024
`Jan 16, 2024
`Jan 16, 2024
`Jan 16, 2024
`Jan 16, 2024
`Jan 16, 2024
`
`Drug Substance
`Claim
`
`Drug Product
`Claim
`
`Patent Use
`Code
`
`Delist
`Requested
`
`Y
`
`Y
`Y
`Y
`Y
`
`Y
`
`U 1095
`U 100
`U 810
`
`Appl No
`
`Prod No
`
`Exclusivity Code
`
`N203168
`
`001
`
`NP
`
`Exclusivity Expiration
`Apr 5, 2016
`
`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 January 2016
`Patent and Generic Drug Product Data Last Updated March 11, 2016
`
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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