`DRUG
`PRODUCTS
`
`WITH
`
`THERAPEUTIC
`EQUIVALENCE
`EVALUATIONS
`31st 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
`
`2011
`
`Mylan Ex.1061 - Page 1 of 5
`Mylan v. Sanofi - IPR2018-01676
`
`
`
`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, 2010.
`
`31st 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
`
`2011
`
`Mylan Ex.1061 - Page 2 of 5
`Mylan v. Sanofi - IPR2018-01676
`
`
`
`FOOD AND DRUG ADMINISTRATION
`CENTER FOR DRUG EVALUATION AND RESEARCH
`APPROVED DRUG PRODUCTS
`with
`Therapeutic Equivalence Evaluations
`
`
`
`CONTENTS
`
`PAGE
`
`PREFACE TO THIRTY FIRST EDITION…………………………… …………..…................iv
`
`INTRODUCTION...................................................................................................................vi
`1
`Content and Exclusion......................................................................................................vi
`1.1
`Therapeutic Equivalence-Related Terms .........................................................................vi
`1.2
`Statistical Criteria for Bioequivalence............................................................................. viii
`1.3
`Reference Listed Drug.......................................................................................................x
`1.4
`General Policies and Legal Status ...................................................................................xi
`1.5
`Practitioner/User Responsibilities.....................................................................................xi
`1.6
`Therapeutic Equivalence Evaluations Codes................................................................. xiii
`1.7
`Description of Special Situations.....................................................................................xx
`1.8
`Therapeutic Equivalence Code Change for a Drug Entity............................................. xxii
`1.9
`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....................................................................................... xxiv
`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
`
`iii
`
`Mylan Ex.1061 - Page 3 of 5
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`
`
`
`31ST EDITION - 2011 - APPROVED DRUG PRODUCTS LIST
`ADA 97 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)
`
`APPL/PROD
`PATENT NO
`NO
`IMATINIB MESYLATE - GLEEVEC
`N021588 001 5521184
`5521184*PED
`6894051
`6894051*PED
`6958335
`6958335*PED
`7544799
`7544799*PED
`IMATINIB MESYLATE - GLEEVEC
`N021588 002 5521184
`5521184*PED
`6894051
`6894051*PED
`6958335
`6958335*PED
`7544799
`7544799*PED
`IMIGLUCERASE - CEREZYME
`N020367 001 5549892
`IMIGLUCERASE - CEREZYME
`N020367 002 5549892
`IMIQUIMOD - ALDARA
`N020723 001 5238944
`5238944*PED
`7696159
`7696159
`7696159*PED
`IMIQUIMOD - IMIQUIMOD
`A078548 001
`IMIQUIMOD - ZYCLARA
`N022483 001
`INDINAVIR SULFATE - CRIXIVAN
`N020685 001 5413999
`6645961
`6689761
`INDINAVIR SULFATE - CRIXIVAN
`N020685 003 5413999
`6645961
`6689761
`INDINAVIR SULFATE - CRIXIVAN
`N020685 005 5413999
`6645961
`6689761
`INDINAVIR SULFATE - CRIXIVAN
`U-132
`May 09, 2012
`N020685 006 5413999
`Mar 04, 2018
`6645961
`U-554
`Feb 10, 2021
`6689761
`INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 50/50
`N021810 001 5547930
`Sep 28, 2013
`DS DP
`5618913
`Jun 07, 2014
`DS DP
`5618913*PED
`Dec 07, 2014
`5834422
`Sep 28, 2013
`DP U-471
`5840680
`Sep 28, 2013
`DS DP U-471
`5866538
`Jun 20, 2017
`DP
`5866538*PED
`Dec 20, 2017
`
`EXCLUSIVITY
`EXPIRATION
`DATE
`
`Dec 19, 2011
`Oct 19, 2013
`Oct 19, 2013
`Oct 19, 2013
`Oct 19, 2013
`Oct 19, 2013
`
`Dec 19, 2011
`Oct 19, 2013
`Oct 19, 2013
`Oct 19, 2013
`Oct 19, 2013
`Oct 19, 2013
`
`Aug 24, 2010
`
`Mar 25, 2013
`
`I-583
`ODE
`ODE
`ODE
`ODE
`ODE
`
`I-583
`ODE
`ODE
`ODE
`ODE
`ODE
`
`PC
`
`NP
`
`Jan 04, 2015
`Jul 04, 2015
`May 23, 2019
`Nov 23, 2019
`Dec 19, 2021
`Jun 19, 2022
`Jan 16, 2019
`Jul 16, 2019
`
`Jan 04, 2015
`Jul 04, 2015
`May 23, 2019
`Nov 23, 2019
`Dec 19, 2021
`Jun 19, 2022
`Jan 16, 2019
`Jul 16, 2019
`
`Aug 27, 2013
`
`Aug 27, 2013
`
`Aug 24, 2010
`Feb 24, 2011
`Apr 01, 2024
`Apr 01, 2024
`Oct 01, 2024
`
`May 09, 2012
`Mar 04, 2018
`Feb 10, 2021
`
`May 09, 2012
`Mar 04, 2018
`Feb 10, 2021
`
`May 09, 2012
`Mar 04, 2018
`Feb 10, 2021
`
`DS DP
`DS DP U-649
`U-791
`
`DS DP
`
`DS DP U-649
`U-791
`
`DS DP
`
`U-252
`
`U-252
`
`DS
`DS
`
`U-1048
`U-1047
`
`DP
`
`U-132
`U-554
`
`DP
`
`U-132
`U-554
`
`DP
`
`U-132
`U-554
`
`DP
`
`Mylan Ex.1061 - Page 4 of 5
`Mylan v. Sanofi - IPR2018-01676
`
`
`
`EXCLUSIVITY
`EXPIRATION
`DATE
`
`DS DP
`
`D-112
`
`Mar 14, 2011
`
`31ST EDITION - 2011 - APPROVED DRUG PRODUCTS LIST
`ADA 98 of 204
`PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
`See report footnote for information regarding report content
`PATENT
`PATENT
`EXPIRATION
`DELIST
`EXCLUSIVITY
`PATENT
`APPL/PROD
`DATE
`REQUESTED
`CODE(S)
`CODES
`PATENT NO
`NO
`INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 70/30
`N021172 001 5547930
`Sep 28, 2013
`DS DP
`5618913
`Jun 07, 2014
`DS DP
`5618913*PED
`Dec 07, 2014
`5834422
`Sep 28, 2013
`DP U-471
`5840680
`Sep 28, 2013
`DS DP U-471
`5866538
`Jun 19, 2017
`DP
`INSULIN ASPART RECOMBINANT - NOVOLOG
`N020986 001 5618913
`Jun 07, 2014
`5618913*PED
`Dec 07, 2014
`5866538
`Jun 20, 2017
`5866538*PED
`Dec 20, 2017
`INSULIN DETEMIR RECOMBINANT - LEVEMIR
`N021536 001 5750497
`May 16, 2019
`5866538
`Jun 20, 2017
`6011007
`Feb 02, 2014
`6869930
`Feb 02, 2014
`INSULIN GLARGINE RECOMBINANT - LANTUS
`N021081 001 5656722
`Aug 12, 2014
`5656722*PED
`Feb 12, 2015
`7476652
`Jul 23, 2023
`7476652*PED
`Jan 23, 2024
`7713930
`Jun 13, 2023
`7713930*PED
`Dec 13, 2023
`INSULIN GLULISINE RECOMBINANT - APIDRA
`N021629 001 6221633
`Jun 18, 2018
`6960561
`Jan 25, 2023
`7452860
`Mar 22, 2022
`7696162
`Mar 22, 2022
`INSULIN GLULISINE RECOMBINANT - APIDRA
`N021629 002 6221633
`Jun 18, 2018
`6960561
`Jan 25, 2023
`7452860
`Mar 22, 2022
`7696162
`Mar 22, 2022
`INSULIN GLULISINE RECOMBINANT - APIDRA SOLOSTAR
`DS DP U-471
`N021629 003 6221633
`Jun 18, 2018
`DP U-471
`6960561
`Jan 25, 2023
`DP
`7452860
`Mar 22, 2022
`DP U-471
`7696162
`Mar 22, 2022
`INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT - HUMALOG MIX 50/50
`N021018 001 5461031
`Jun 26, 2014
`5474978
`Jun 16, 2014
`5514646
`May 07, 2013
`5747642
`Jun 16, 2014
`INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT - HUMALOG MIX 75/25
`N021017 001 5461031
`Jun 16, 2014
`5474978
`Jun 16, 2014
`5514646
`May 07, 2013
`5747642
`Jun 16, 2014
`INSULIN LISPRO RECOMBINANT - HUMALOG
`N020563 001 5474978
`Jun 16, 2014
`5514646
`May 07, 2013
`INSULIN LISPRO RECOMBINANT - HUMALOG PEN
`N020563 002 5474978
`Jun 16, 2014
`5514646
`May 07, 2013
`
`DS DP U-948
`DP
`DP
`
`NPP
`
`Oct 24, 2011
`
`NPP
`
`Oct 24, 2011
`
`NPP
`
`Oct 24, 2011
`
`DS DP U-668
`DP
`DS DP U-668
`DS DP U-668
`
`DS DP U-471
`DP U-471
`DP
`DP U-471
`
`DS DP U-471
`DP U-471
`DP
`DP U-471
`
`U-534
`U-534
`
`U-534
`U-534
`
`Mylan Ex.1061 - Page 5 of 5
`Mylan v. Sanofi - IPR2018-01676
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`