`
`
`
`
`
`
`
`
`
`
`
`
`
`
`APPROVED
`
`DRUG
`
`PRODUCTS
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`WITH
`
`THERAPEUTIC
`
`EQUIVALENCE
`EVALUATIONS
`33rd EDITION
`
`
`
`
`
`
`
`
`
`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
`
`
`
`2013
`
`Novo Nordisk A/S Ex. 2004, P. 1
`Fresenius Kabi v. Novo Nordisk
`IPR2022-00657
`
`
`
`
`
`APPROVED DRUG PRODUCTS
`
`with
`THERAPEUTIC EQUIVALENCE EVALUATIONS
`
`
`
`
`
`
`
`The products in this list have been approved under section 505 of the
`Federal Food, Drug, and Cosmetic Act. This volume is current through
`December 31, 2012.
`
`
`
`
`
`
`
`33rd EDITION
`
`
`
`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
`
`
`2013
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Novo Nordisk A/S Ex. 2004, P. 2
`Fresenius Kabi v. Novo Nordisk
`IPR2022-00657
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`FOOD AND DRUG ADMINISTRATION
`CENTER FOR DRUG EVALUATION AND RESEARCH
`APPROVED DRUG PRODUCTS
`with
`Therapeutic Equivalence Evaluations
`
`CONTENTS
`
`PAGE
`
`
`PREFACE TO THIRTY THIRD EDITION………………………………………..…................iv
`
`
`
`
`
`1
`INTRODUCTION...................................................................................................................vi
`
`
`
`1.1
`Content and Exclusion......................................................................................................vi
`
`
`
`1.2
`Therapeutic Equivalence-Related Terms .........................................................................vi
`
`
`
`1.3
`Statistical Criteria for Bioequivalence............................................................................. viii
`
`
`
`1.4
`Reference Listed Drug.......................................................................................................x
`
`
`
`1.5
`General Policies and Legal Status ...................................................................................xi
`
`
`
`1.6
`Practitioner/User Responsibilities.....................................................................................xi
`
`
`
`1.7
`Therapeutic Equivalence Evaluations Codes................................................................. xiii
`
`
`
`1.8
`Description of Special Situations.....................................................................................xx
`
`
`
`1.9
`Therapeutic Equivalence Code Change for a Drug Entity............................................. xxii
`
`
`
`1.10 Change of the Therapeutic Equivalence Evaluation for a Single Product.................... xxiii
`
`
`
`1.11 Discontinued Section.................................................................................................... xxiii
`
`
`
`1.12 Changes to the Orange Book....................................................................................... xxiii
`
`
`
`1.13 Availability of the Edition............................................................................................... xxiv
`
`
`
` 2 HOW TO USE THE DRUG PRODUCTS LISTS ..............................................................2-1
`
`2.1
`Key Sections for Using the Drug Product Lists …………………….….………………......2-1
`
`2.2
`Drug Product Illustration ……………………………………………..….…………….……..2-3
`
`2.3
`Therapeutic Equivalence Evaluations Illustration ………………….….…………..………2-4
`
`
`
`
`
`
`DRUG PRODUCT LISTS
`
`Prescription Drug Product List ……………………………………….…………….………………...3-1
`
`OTC Drug Product List ……………………………………………….…………….…………………4-1
`
`Drug Products with Approval under Section 505 of the Act Administered
`
`by the Center for Biologics Evaluation and Research List ...……….…….………………...5-1
`
`Discontinued Drug Product List .…………………………………………….…….………………....6-1
`
`Orphan Products Designations and Approvals List …………….………….…….………………..7-1
`
`Drug Products Which Must Demonstrate in vivo Bioavailability
`
`Only if Product Fails to Achieve Adequate Dissolution …………………..………………………..8-1
`
`
`
`APPENDICES
`A. Product Name Index ……….…...………………………….………..……………………A-1
`B. Product Name Index Listed by Applicant ………………….……..……………………..B-1
`
`C. Uniform Terms …………………………………………….………..…………...………...C-1
`
`
`
`PATENT AND EXCLUSIVITY INFORMATION ADDENDUM ……….……..………………..........AD1
`
`A. Patent and Exclusivity Lists …………………………….…..……..……………..……ADA1
`B. Patent and Exclusivity Terms ...……………………….….………...…………………ADB1
`
`
`
`
`
`Novo Nordisk A/S Ex. 2004, P. 3
`Fresenius Kabi v. Novo Nordisk
`IPR2022-00657
`
`
`
`33RD EDITION - 2013 - APPROVED DRUG PRODUCTS LIST
`ADA 121 of 227
`PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
` See report footnote for information regarding report content
`
`PATENT
`PATENT
`EXPIRATION
`DELIST
`DATE
`REQUESTED
`
`EXCLUSIVITY
`CODE(S)
`
`EXCLUSIVITY
`EXPIRATION
`DATE
`
`PATENT
`CODES
`
`18, 2014
`18, 2015
`29, 2021
`29, 2021
`
`APPL/PROD
`PATENT NO
`NO
`LINEZOLID - ZYVOX
`Nov
`N021132 001 5688792
`May
`5688792*PED
`Jan
`6559305
`Jul
`6559305*PED
`LIRAGLUTIDE RECOMBINANT - VICTOZA
`28, 2019
`Jan
`N022341 001 6004297
`Aug
`22, 2017
`6268343
`Aug
`22, 2017
`6458924
`Aug
`22, 2017
`7235627
`Aug
`13, 2025
`8114833
`Jan
`21, 2021
`RE41956
`Jan
`28, 2019
`RE43834
`LISDEXAMFETAMINE DIMESYLATE - VYVANSE
`N021977 001 7105486
`Jun
`29, 2023
`7223735
`Jun
`29, 2023
`7655630
`Feb
`24, 2023
`7659253
`Feb
`24, 2023
`7659254
`Feb
`24, 2023
`7662787
`Feb
`24, 2023
`7662788
`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
`7713936
`24, 2023
`Feb
`7718619
`24, 2023
`Feb
`7723305
`24, 2023
`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
`7662788
`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
`7713936
`24, 2023
`Feb
`7718619
`24, 2023
`Feb
`7723305
`24, 2023
`
`M-115
`NCE
`
`Apr 06, 2015
`Jan 25, 2015
`
`I-645
`M-82
`NPP
`
`Jan 31, 2015
`Apr 05, 2013
`Nov 10, 2013
`
`I-645
`M-82
`NPP
`
`Jan 31, 2015
`Apr 05, 2013
`Nov 10, 2013
`
`DS
`DS
`
`DS
`DS
`DS
`
`DS
`DS
`DS
`
`DS
`DS
`DS
`
`U-319
`
`U-968
`U-968
`
`U-727
`
`U-727
`U-1034
`U-727
`U-727
`U-727
`U-842
`U-842
`U-842
`U-842
`U-727
`U-842
`U-842
`
`U-727
`
`U-727
`U-1034
`U-727
`U-727
`U-727
`U-842
`U-842
`U-842
`U-842
`U-727
`U-842
`U-842
`
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`
`DP
`DP
`
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`
`DP
`DP
`
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`
`Novo Nordisk A/S Ex. 2004, P. 4
`Fresenius Kabi v. Novo Nordisk
`IPR2022-00657
`
`
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