`
`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 021196 Product 001 in the OB_Rx list.
`
`Patent Data
`
`Appl No
`
`Prod No
`
`Patent No
`
`N021196
`N021196
`N021196
`N021196
`N021196
`N021196
`N021196
`N021196
`N021196
`N021196
`N021196
`N021196
`N021196
`N021196
`N021196
`N021196
`N021196
`N021196
`N021196
`N021196
`
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`
`6780889
`7262219
`7668730
`7765106
`7765107
`7851506
`7851506
`7895059
`8263650
`8263650
`8324275
`8324275
`8457988
`8589182
`8731963
`8772306
`8859619
`8952062
`8952062
`9050302
`
`Patent
`Expiration
`Jul 4, 2020
`Jul 4, 2020
`Jun 16, 2024
`Jun 16, 2024
`Jun 16, 2024
`Dec 22, 2019
`Dec 22, 2019
`Dec 17, 2022
`Dec 22, 2019
`Dec 22, 2019
`Dec 22, 2019
`Dec 22, 2019
`Dec 17, 2022
`Dec 17, 2022
`Dec 17, 2022
`Mar 15, 2033
`Dec 22, 2019
`Dec 22, 2019
`Dec 22, 2019
`Mar 15, 2033
`
`Drug Substance
`Claim
`
`Drug Product
`Claim
`
`Patent Use
`Code
`
`Delist
`Requested
`
`Y
`Y
`
`Y
`Y
`
`Y
`
`U - 1110
`U - 1069
`U - 1070
`U - 1101
`U - 1102
`U - 1110
`U - 1101
`U - 1102
`U - 1101
`U - 1102
`U - 1110
`U - 1110
`U - 1110
`U - 1532
`
`U - 1101
`U - 1102
`U - 1532
`
`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 July 2015
`Patent and Generic Drug Product Data Last Updated September 08, 2015
`
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`http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=021196&Product_No=001&table1=OB_Rx
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`PAR1005
`IPR of U.S. Patent No. 8,772,306
`Page 1 of 2
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`
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`9/9/2015
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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`2/2
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`PAR1005
`IPR of U.S. Patent No. 8,772,306
`Page 2 of 2