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`Orange Book Approved Drug Products with Therapeutic Eq uivalence Evaluations
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`Search results from the "OB_Rx" table for query on "021196."
`
`Active Ingredient:
`Dosage Form;Route:
`Proprietary Name:
`Applicant:
`Strength:
`Application Number:
`Product Number:
`
`Approval Date:
`Reference Listed Drug
`RX/OTC/DISCN:
`TE Code:
`
`SODIUM OXYBATE
`SOLUTION;ORAL
`XYREM
`JAZZ PHARMS
`500MG/ML
`N021196
`001
`
`Jul 17, 2002
`Yes
`RX
`
`Patent and Exclusivity Info for this product: View
`
`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 April 2014
`Patent and Generic Drug Product Data Last Updated June 11, 2014
`
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`http://iAMANaccessdatafdag ov/scri pts/cder/ob/docs/obdetail .cfm?Appl_N o= 021 196&TABLE1= OB_R><
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`PAR1021
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`CBM of U.S. Patent No. 7,668,730
`Page 1 of4
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`Page 1 of 4
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`6/12/2014
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`Orange Book Approved Drug Products with Therapeutic Eq uivalence Evaluations
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`PAR1021
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`CBM of US. Patent No. 7,668,730
`Page 2 of 4
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`Page 2 of 4
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`6/4/2014
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`Orange Book Approved Drug Products with Therapeutic Equivalence Ewluations
`
`A) U.S. Food and Drug Administration Protectino and Promotim “(our Health
`
`EDA Home3 Drug Data[151321.554 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.
`
`Patent Data
`
`No
`
`N021196
`N021196
`N021196
`
`N021196
`N021196
`N021196
`
`N021196
`N021196
`N021196
`N02‘1196
`N02‘1196
`N021196
`N0211'96,
`N021196
`NU2‘1196
`
`001
`001
`001
`
`001
`001
`001
`
`001
`001
`001
`001
`001
`001
`001
`001
`001
`
`ProoNo No
`6780889
`7262219
`7668730
`
`553232.. Mitt?“ ”’“%IZI:;““°*
`Jul 4, 2020
`Y
`Jul 4, 2020
`Y
`Jun 16, 2024
`
`7765106
`7765107
`7851506
`
`7851506
`7895059
`8263650
`8263650
`8324275
`8324275
`8457988
`8589182
`8731963
`
`V
`
`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
`
`Y
`Y
`
`”‘53:?”
`
`Reifiiiid
`
`U - 1110
`
`U - 1069
`U - 1070
`U -1101
`
`U - 1402
`U - 1110
`U - 1101
`U - 1102
`U - 1101
`U - 1102
`U -1110
`U -1110
`U -1110
`
`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 priorto 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
`Viewa 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 May 2014
`Patent and Generic Drug Product Data Last Updated June 03, 2014
`
`Links on this page:
`1. http://wwwaddthis.com/bookmark.php?u508=true&v=152&username=fdamain
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`. http://wvvw.fda.gov/Drugs/lnformationOnDrugs/default.htm
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`6 .
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`../default.cfm
`
`Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
`Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency Website Policies
`
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`Ph. 1-888-INFO-F DA (1 -888-463-6332)
`
`http://iAMANaccessdatafdag ov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=O21196&Product_N o=001&table1 = OB_RX
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`PAR1021
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`CBM of US. Patent No. 7,668,730
`Page 3 of 4
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`Page 3 of 4
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`6/4/2014
`Email FDA
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`Orange Book Approved Drug Products with Therapeutic Equivalence Ewluations
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`PAR102’I
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`CBM of US. Patent NO. 7,668,730
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