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`Equivalence Evaluations
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`
`Product Details for NDA 022063
`Collapse All
`
`MYDAYIS (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE;
`DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE
`SULFATE)
`3.125MG;3.125MG;3.125MG;3.125MG
`
`Marketing Status: Prescription
`
`Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE
`SULFATE; DEXTROAMPHETAMINE SACCHARATE;
`DEXTROAMPHETAMINE SULFATE
`Proprietary Name: MYDAYIS
`
`1/25/2018, 1:14 PM
`
`p.1
`
`SHIRE EX. 2003
`KVK v. SHIRE
`IPR2018-00290
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence E...
`
`https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?App...
`
`Dosage Form; Route of Administration: CAPSULE, EXTENDED
`RELEASE; ORAL
`Strength: 3.125MG;3.125MG;3.125MG;3.125MG
`Reference Listed Drug: Yes
`Reference Standard: No
`TE Code:
`Application Number: N022063
`Product Number: 001
`Approval Date: Jun 20, 2017
`Applicant Holder Full Name: SHIRE DEVELOPMENT LLC
`Marketing Status: Prescription
`Patent and Exclusivity Information
`(patent_info.cfm?Product_No=001&Appl_No=022063&
`Appl_type=N)
`
`MYDAYIS (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE;
`DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE
`SULFATE)
`6.25MG;6.25MG;6.25MG;6.25MG
`
`Marketing Status: Prescription
`
`Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE
`SULFATE; DEXTROAMPHETAMINE SACCHARATE;
`DEXTROAMPHETAMINE SULFATE
`Proprietary Name: MYDAYIS
`Dosage Form; Route of Administration: CAPSULE, EXTENDED
`RELEASE; ORAL
`Strength: 6.25MG;6.25MG;6.25MG;6.25MG
`Reference Listed Drug: Yes
`Reference Standard: No
`TE Code:
`Application Number: N022063
`Product Number: 002
`Approval Date: Jun 20, 2017
`Applicant Holder Full Name: SHIRE DEVELOPMENT LLC
`Marketing Status: Prescription
`Patent and Exclusivity Information
`(patent_info.cfm?Product_No=002&Appl_No=022063&
`Appl_type=N)
`
`MYDAYIS (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE;
`DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE
`
`1/25/2018, 1:14 PM
`
`p.2
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence E...
`
`https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?App...
`
`SULFATE)
`9.375MG;9.375MG;9.375MG;9.375MG
`
`Marketing Status: Prescription
`
`Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE
`SULFATE; DEXTROAMPHETAMINE SACCHARATE;
`DEXTROAMPHETAMINE SULFATE
`Proprietary Name: MYDAYIS
`Dosage Form; Route of Administration: CAPSULE, EXTENDED
`RELEASE; ORAL
`Strength: 9.375MG;9.375MG;9.375MG;9.375MG
`Reference Listed Drug: Yes
`Reference Standard: No
`TE Code:
`Application Number: N022063
`Product Number: 003
`Approval Date: Jun 20, 2017
`Applicant Holder Full Name: SHIRE DEVELOPMENT LLC
`Marketing Status: Prescription
`Patent and Exclusivity Information
`(patent_info.cfm?Product_No=003&Appl_No=022063&
`Appl_type=N)
`
`MYDAYIS (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE;
`DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE
`SULFATE)
`12.5MG;12.5MG;12.5MG;12.5MG
`
`Marketing Status: Prescription
`
`Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE
`SULFATE; DEXTROAMPHETAMINE SACCHARATE;
`DEXTROAMPHETAMINE SULFATE
`Proprietary Name: MYDAYIS
`Dosage Form; Route of Administration: CAPSULE, EXTENDED
`RELEASE; ORAL
`Strength: 12.5MG;12.5MG;12.5MG;12.5MG
`Reference Listed Drug: Yes
`Reference Standard: No
`TE Code:
`Application Number: N022063
`Product Number: 004
`Approval Date: Jun 20, 2017
`Applicant Holder Full Name: SHIRE DEVELOPMENT LLC
`Marketing Status: Prescription
`
`1/25/2018, 1:14 PM
`
`p.3
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`
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`Orange Book: Approved Drug Products with Therapeutic Equivalence E...
`
`https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?App...
`
`Patent and Exclusivity Information
`(patent_info.cfm?Product_No=004&Appl_No=022063&
`Appl_type=N)
`
`1/25/2018, 1:14 PM
`
`p.4
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`
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`Orange Book: Approved Drug Products with Therapeutic Equivalence E...
`
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`
`Orange Book: Approved Drug
`Products with Therapeutic
`Equivalence Evaluations
`
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`TS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS&URL=HTTPS://WWW.ACCESSDATA.FDA.GOV/SC
`RIPTS/CDER/OB/PATENT_INFO.CFM?PRODUCT_NO=004&APPL_NO=022063&APPL_TYPE=N)
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`DATA.FDA.GOV/SCRIPTS/CDER/OB/PATENT_INFO.CFM?PRODUCT_NO=004&APPL_NO=022063&APPL_T
`YPE=N&TITLE=ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVA
`LUATIONS&SOURCE=FDA)
`
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`LUATIONS)
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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.
`
`1/25/2018, 1:15 PM
`
`p.5
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`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence E...
`
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`
`Patent and Exclusivity for: N022063
`
`Product 004
`AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE;
`DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE
`SULFATE (MYDAYIS) CAPSULE, EXTENDED RELEASE
`12.5MG;12.5MG;12.5MG;12.5MG
`
`Patent Data
`
`Product
`No
`
`Patent
`No
`
`Patent
`Expiration
`
`Drug
`Substance
`
`Drug
`Product Patent Use Code
`
`004
`
`6913768
`
`05/24/2023
`
`004
`
`8846100
`
`08/24/2029
`
`004
`
`9173857
`
`05/12/2026
`
`004
`
`RE41148
`
`10/21/2018
`
`004
`
`RE42096
`
`10/21/2018
`
`DP
`
`DP
`
`DP
`
`DP
`
`U-2025
`(show_code.cfm?id=2060&
`type=0)
`
`(show_code.cfm?id=&
`type=0)
`
`U-2025
`(show_code.cfm?id=2060&
`type=0)
`
`(show_code.cfm?id=&
`type=0)
`
`(show_code.cfm?id=&
`type=0)
`
`Exclusivity Data
`
`Product
`No
`
`004
`
`Exclusivity Code
`
`NP (show_code.cfm?id=1156&
`type=1)
`
`Exclusivity
`Expiration
`
`06/20/2020
`
`View a list of all patent use codes (results_patent.cfm)
`View a list of all exclusivity codes (results_exclusivity.cfm)
`
`1/25/2018, 1:15 PM
`
`p.6
`
`