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`APPROVED
`
`
`DRUG
`
`PRODUCTS
`
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`
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`
`
`WITH
`
`THERAPEUTIC
`
`
`EQUIVALENCE
`
`EVALUATIONS
`
`31st EDITION
`
`
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`
`
`THE PRODUCTS IN THIS LIST HAVE BEEN APPROVED UNDER
`SECTION 505 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.
`
`U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`FOOD AND DRUG ADMINISTRATION
`
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`OFFICE OF PHARMACEUTICAL SCIENCE
`OFFICE OF GENERIC DRUGS
`
`
`
`2011
`
`MPI EXHIBIT 1105 PAGE 1
`
`
`
`31ST EDITION - 2011 - APPROVED DRUG PRODUCTS LIST
`ADA 111 of 204
`PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
` See report footnote for information regarding report content
`
`PATENT
`PATENT
`EXPIRATION
`DELIST
`DATE
`REQUESTED
`
`PATENT
`CODES
`
`EXCLUSIVITY
`CODE(S)
`
`EXCLUSIVITY
`EXPIRATION
`DATE
`
`DS
`
`U-319
`
`DP
`
`DS
`
`DS
`
`DS
`DS
`
`U-319
`
`U-319
`
`DS
`DS
`DS
`
`DP
`DP
`DP
`
`U-968
`U-968
`
`DS
`DS
`DS
`
`DS
`DS
`DS
`
`U-727
`
`U-727
`U-1034
`U-727
`U-727
`U-842
`U-842
`U-842
`U-842
`U-842
`U-842
`
`U-727
`
`U-727
`U-1034
`U-727
`U-727
`U-842
`U-842
`U-842
`U-842
`U-842
`U-842
`
`DP
`DP
`
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`
`DP
`DP
`
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`
`NCE
`
`Jan 25, 2015
`
`M-82
`NPP
`NPP
`NCE
`
`Apr 05, 2013
`Nov 10, 2013
`Apr 23, 2011
`Feb 23, 2012
`
`M-82
`NPP
`NPP
`NCE
`
`Apr 05, 2013
`Nov 10, 2013
`Apr 23, 2011
`Feb 23, 2012
`
`Nov
`May
`Mar
`Sep
`Jan
`Jul
`
`18, 2014
`18, 2015
`15, 2021
`15, 2021
`29, 2021
`29, 2021
`
`Nov
`May
`Jan
`Jul
`
`18, 2014
`18, 2015
`29, 2021
`29, 2021
`
`18, 2014
`18, 2015
`29, 2021
`29, 2021
`
`APPL/PROD
`PATENT NO
`NO
`LINEZOLID - ZYVOX
`N021130 002 5688792
`5688792*PED
`6514529
`6514529*PED
`6559305
`6559305*PED
`LINEZOLID - ZYVOX
`N021131 001 5688792
`5688792*PED
`6559305
`6559305*PED
`LINEZOLID - ZYVOX
`Nov
`N021132 001 5688792
`May
`5688792*PED
`Jan
`6559305
`Jul
`6559305*PED
`LIRAGLUTIDE RECOMBINANT - VICTOZA
`N022341 001 6268343
`Aug
` 22, 2017
`Aug
`6458924
`22, 2017
`Aug
`7235627
`22, 2017
`LISDEXAMFETAMINE DIMESYLATE - VYVANSE
`29, 2023
`Jun
`N021977 001 7105486
`29, 2023
`Jun
`7223735
`24, 2023
`Feb
`7655630
`24, 2023
`Feb
`7659253
`24, 2023
`Feb
`7659254
`24, 2023
`Feb
`7662787
`24, 2023
`Feb
`7671030
`28, 2023
`Feb
`7671031
`18, 2023
`Mar
`7674774
`25, 2023
`Mar
`7678770
`25, 2023
`Mar
`7678771
`24, 2023
`Feb
`7687466
`Apr
`08, 2023
`7687467
`Jun
`29, 2023
`7700561
`Feb
`24, 2023
`7718619
`Feb
`24, 2023
`7723305
`LISDEXAMFETAMINE DIMESYLATE - VYVANSE
`N021977 002 7105486
`Jun
`29, 2023
`7223735
`Jun
`29, 2023
`7655630
`Feb
`24, 2023
`7659253
`Feb
`24, 2023
`7659254
`Feb
`24, 2023
`7662787
`Feb
`24, 2023
`7671030
`Feb
`24, 2023
`7671031
`Feb
`28, 2023
`7674774
`Mar
`18, 2023
`7678770
`Mar
`25, 2023
`7678771
`Mar
`25, 2023
`7687466
`Feb
`24, 2023
`Apr
`7687467
`08, 2023
`Jun
`7700561
`29, 2023
`Feb
`7718619
`24, 2023
`Feb
`7723305
`24, 2023
`
`MPI EXHIBIT 1105 PAGE 2
`
`