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`FDA Home3Drug Databases4Orange 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 OB_Rx list.
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`Patent Data
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`Appl No
`
`Prod No
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`Patent No
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`Patent
`Expiration
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`Drug
`Substance
`Claim
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`Drug Product
`Claim
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`Patent Use
`Code
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`Delist
`Requested
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`N203168
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`001
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`8129431
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`Sep 11, 2025
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`Y
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`Y
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`Exclusivity Data
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`Appl No
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`Prod No
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`Exclusivity Code
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`N203168
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`001
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`NP
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`Exclusivity Expiration
`Apr 5, 2016
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`Additional information:
`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
`1.
`(d)(5).
`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.
`
`2.
`
`
`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 01, 2014
`Patent and Generic Drug Product Data Last Updated: January 24, 2014
`
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`http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=203168&P...
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`1/24/2014
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`Innopharma EX1013, Page 1
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`Patent and Exclusivity Search Results
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`Page 2 of 2
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`5.
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`../default.cfm
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`http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=203168&P...
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`1/24/2014
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`Innopharma EX1013, Page 2
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