`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`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 205552 Product 001 in the OB_Rx list.
`
`Patent Data
`
`Appl No
`
`Prod No
`
`Patent No
`
`N205552
`N205552
`N205552
`N205552
`N205552
`N205552
`N205552
`N205552
`N205552
`N205552
`N205552
`N205552
`N205552
`N205552
`N205552
`
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`
`Exclusivity Data
`
`7514444
`8008309
`8476284
`8476284
`8497277
`8497277
`8497277
`8697711
`8703780
`8735403
`8754090
`8754091
`8957079
`8999999
`8999999
`
`Patent
`Expiration
`Dec 28, 2026
`Dec 28, 2026
`Dec 28, 2026
`Dec 28, 2026
`Dec 28, 2026
`Dec 28, 2026
`Dec 28, 2026
`Dec 28, 2026
`Dec 28, 2026
`Dec 28, 2026
`Jun 3, 2031
`Dec 28, 2026
`Dec 28, 2026
`Jun 3, 2031
`Jun 3, 2031
`
`Drug Substance
`Claim
`
`Drug Product
`Claim
`
`Patent Use
`Code
`
`Delist
`Requested
`
`Y
`Y
`
`Y
`
`Y
`
`Y
`
`Y
`Y
`
`Y
`
`Y
`
`Y
`Y
`
`U 1456
`U 1491
`U 1650
`U 1491
`U 1456
`
`U 1491
`
`U 1456
`
`U 1684
`U 1683
`
`Appl No
`
`Prod No
`
`Exclusivity Code
`
`N205552
`N205552
`N205552
`N205552
`N205552
`N205552
`N205552
`N205552
`
`001
`001
`001
`001
`001
`001
`001
`001
`
`I 702
`I 689
`I 680
`ODE
`ODE
`ODE
`ODE
`NCE
`
`Exclusivity Expiration
`Jan 29, 2018
`Jul 28, 2017
`Feb 12, 2017
`Jan 29, 2022
`Jul 28, 2021
`Feb 12, 2021
`Nov 13, 2020
`Nov 13, 2018
`
`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 June 2015
`Patent and Generic Drug Product Data Last Updated August 11, 2015
`
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`https://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=205552&Product_No=001&table1=OB_Rx
`
`1/2
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`Coalition for Affordable Drugs IV LLC - Exhibit 1029
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`
`
`8/11/2015
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`4. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`5. ../default.cfm
`6. ../default.cfm
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`4. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`5. ../default.cfm
`6. ../default.cfm
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`https://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=205552&Product_No=001&table1=OB_Rx
`
`2/2
`
`Coalition for Affordable Drugs IV LLC - Exhibit 1029
`
`