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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Orange Book: Approved Drug Products with
`Therapeutic Equivalence Evaluations
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`Home (index.cfm?resetfields=1) I Back to Product Details
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`Additional Information about Patents
`
`• Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
`• Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or
`drug product claims that are not indicated in the listing.
`
`• As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is
`eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Orange Book users
`should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be
`asserted by an NDA holder or patent owner.
`
`Patent and Exclusivity for: N203284
`
`Product 001
`GLYCEROL PHENYLBUTYRATE (RAVICTI) LIQUID 1.1GM/ML
`
`Patent Data
`
`Product Patent
`No
`No
`
`Patent
`Expiration
`
`Drug
`Substance
`
`Drug
`Product
`
`Patent Use
`Code
`
`De list
`Requested
`
`Submission
`Date
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`5968979 07/28/2018
`
`DS
`
`DP
`
`8404215 03/09/2032
`
`8642012 09/22/2030
`
`9095559 03/09/2032
`
`9254278 03/09/2032
`
`9326966 03/09/2032
`
`9561197 09/22/2030
`
`9962359 09/22/2030
`
`U-1378
`
`U-1383
`
`U-1383
`·························-
`
`U-1383
`..........................
`
`U-1816
`·························-
`
`U-1816
`
`U-1383
`
`U-1816
`·························-
`
`04/22/2013
`
`04/25/2013
`
`02/27/2014
`
`09/03/2015
`
`02/29/2016
`
`05/25/2016
`
`07/06/2017
`
`06/07/2018
`
`https://www.accessdata.fda.gov/scripts/Cder/oblpatent_info.cfm?Product_No=001&Appi_No=203284&Appl_type=N
`
`1/2
`
`Par Pharmaceutical, Inc. Ex. 1027
`Par v. Horizon, IPR of Patent No. 9,561,197
`Page 1 of 2
`
`
`
`6/19/2018
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Exclusivity Data
`
`Product No
`
`Exclusivity Code
`
`Exclusivity Expiration
`
`001
`
`001
`
`001
`
`ODE-42
`
`NPP
`
`ODE-157
`
`02/01/2020
`
`04/28/2020
`
`04/28/2024
`
`View a list of all patent use codes (results patent.cfm)
`View a list of all exclusivity codes (results exclusivity.cfm)
`
`https://www.accessdata.fda.gov/scripts/Cder/oblpatent_info.cfm?Product_No=001&Appi_No=203284&Appl_type=N
`
`212
`
`Par Pharmaceutical, Inc. Ex. 1027
`Par v. Horizon, IPR of Patent No. 9,561,197
`Page 2 of 2
`
`