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`FDA Home3 Drug Databases4 Orange Book5
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`Patent and Exclusivity Search Results from query on Appl No 021196 Product 001 in the OB_Rx list.
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`Patent Data
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`Appl No
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`Prod No
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`Patent No
`
`Patent
`Expiration
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`Drug Substance
`Claim
`
`Drug Product
`Claim
`
`Patent Use
`Code
`
`Delist
`Requested
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`N021196
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`N021196
`
`N021196
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`N021196
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`N021196
`
`N021196
`
`N021196
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`N021196
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`N021196
`
`N021196
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`6780889
`
`7262219
`
`7668730
`
`7765106
`
`7765107
`
`7851506
`
`7851506
`
`7895059
`
`8263650
`
`8263650
`
`Jul 4, 2020
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`Jul 4, 2020
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`Jun 16, 2024
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`Jun 16, 2024
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`Jun 16, 2024
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`Dec 22, 2019
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`Dec 22, 2019
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`Dec 17, 2022
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`Dec 22, 2019
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`Dec 22, 2019
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`Dec 22, 2019
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`Y
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`Y
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`Y
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`Y
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`U - 1110
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`U - 1069
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`U - 1070
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`U - 1101
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`U - 1102
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`U - 1110
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`U - 1101
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`U - 1102
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`U - 1101
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`N021196
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`N021196
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`N021196
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`N021196
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`N021196
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`N021196
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`N021196
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`N021196
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`N021196
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`N021196
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`001
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`001
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`001
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`001
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`001
`
`001
`
`001
`
`001
`
`001
`
`001
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`8324275
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`8324275
`
`8457988
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`8589182
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`8731963
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`8772306
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`8859619
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`8952062
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`8952062
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`9050302
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`Dec 22, 2019
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`Dec 17, 2022
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`Dec 17, 2022
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`Dec 17, 2022
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`Mar 15, 2033
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`Dec 22, 2019
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`Dec 22, 2019
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`Dec 22, 2019
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`Mar 15, 2033
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`Exclusivity Data
`There is no unexpired exclusivity for this product.
`
`Additional information:
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`U - 1102
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`U - 1110
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`U - 1110
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`U - 1110
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`U - 1532
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`U - 1101
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`U - 1102
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`U - 1532
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`Y
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`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
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`Return to Electronic Orange Book Home Page6
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`FDA/Center for Drug Evaluation and Research
`Office of Generic Drugs
`Division of Labeling and Program Support
`Update Frequency:
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`Orange Book Data - Monthly
`Generic Drug Product Information & Patent Information - Daily
`Orange Book Data Updated Through September 2015
`Patent and Generic Drug Product Data Last Updated November 03, 2015
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`JAZZ EXHIBIT 2051
`Amneal Pharms. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case IPR2015-00547
`
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