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`
`
`
`
`
`
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`
`
`
`
`
`
` APPROVED
`
`
` DRUG
`
`PRODUCTS
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` WITH
`
`
`
` THERAPEUTIC
`
`
` EQUIVALENCE
`
`
` EVALUATIONS
`
`
` 39th 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
`
` OFFICE OF MEDICAL PRODUCTS AND TOBACCO
`
`
` CENTER FOR DRUG EVALUATION AND RESEARCH
`
`
`
` OFFICE OF GENERIC DRUGS
` OFFICE OF GENERIC DRUG POLICY
`
`
`
` 2019
`
`
`
`
`
`
`Mylan Ex.1062 - Page 1 of 5
`Mylan v. Sanofi - IPR2018-01676
`
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`
`
`
`
`
` APPROVED
`
`
` DRUG
`
`PRODUCTS
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` WITH
`
`
`
` THERAPEUTIC
`
`
` EQUIVALENCE
`
`
` EVALUATIONS
`
`
` 39th 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
`
` OFFICE OF MEDICAL PRODUCTS AND TOBACCO
`
`
` CENTER FOR DRUG EVALUATION AND RESEARCH
`
`
`
` OFFICE OF GENERIC DRUGS
` OFFICE OF GENERIC DRUG POLICY
`
`
`
` 2019
`
`
`
`
`
`
`Mylan Ex.1062 - Page 2 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, 2018.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 39th EDITION
`
`
`
`
`
`
`
` U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
` FOOD AND DRUG ADMINISTRATION
`
` OFFICE OF MEDICAL PRODUCTS AND TOBACCO
`
`
` CENTER FOR DRUG EVALUATION AND RESEARCH
`
`
`
` OFFICE OF GENERIC DRUGS
`
` OFFICE OF GENERIC DRUG POLICY
`
`
`
`
`
`
` 2019
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Mylan Ex.1062 - Page 3 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-NINTH EDITION…...…….……………………………..…................iv
`
`
`
`
`1.0
`INTRODUCTION ........................................................................................................... vi
`
`
`
`
`
`1.1
` Content and Exclusion................................................................................................... vi
`
`
`
`
`
`1.2
`Therapeutic Equivalence-Related Terms .......................................................................vii
`
`
`
`
` Further Guidance on Bioequivalence ............................................................................. ix
`
`1.3
`
`
`
`
`
`1.4
` Reference Listed Drug and Reference Standard............................................................ ix
`
`
`
`
`
`1.5
`General Policies and Legal Status .................................................................................. x
`
`
`
`
`1.6
`Practitioner/User Responsibilities .................................................................................. xi
`
`
`
`
`
`1.7
` Therapeutic Equivalence Evaluations Codes ................................................................xiii
`
`
`
`
`
` Description of Certain Special Situations ......................................................................xxi
`
`1.8
`
`
`
`
`1.9
`Therapeutic Equivalence Code Change for a Drug Entity ...........................................xxiii
`
`
`
`
`
`1.10 Change of the Therapeutic Equivalence Evaluation for a Single Product....................xxiv
`
`
`
`
`
`
`1.11 Discontinued Section ...................................................................................................xxv
`
`
`
`
`
`1.12 Changes to the Orange Book.......................................................................................xxv
`
`
`
`
`
`
`1.13 Availability of the Edition .............................................................................................xxvi
`
`
`
`
`
`
`
`
`
`HOW TO USE THE DRUG PRODUCTS LISTS .............................................................2-1
`
`2.0
`
`
`
`
`
`Key Sections for Using the Drug Product Lists …………………….….………………......2-1
`
`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 FD&C 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
`
`
`
`
`
`
`Mylan Ex.1062 - Page 4 of 5
`Mylan v. Sanofi - IPR2018-01676
`
`
`
`39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST
`ADA 132 of 263
`
`PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
`
`See report footnote for information regarding report content
`
`APPL/PROD
`NO
`
`PATENT
`EXPIRATION
`PATENT NO
`DATE
`INSULIN DETEMIR RECOMBINANT - LEVEMIR FLEXTOUCH
`N 021536 005 9616180
`Jan 20, 2026
`9687611
`Feb 27, 2027
`9775953
`Jul 17, 2026
`9861757
`Jan 20, 2026
`RE46363
`Aug 03, 2026
`INSULIN GLARGINE RECOMBINANT - LANTUS
`N 021081 001 7476652
`Jul 23, 2023
`7713930
`Jun 13, 2023
`7918833
`Sep 23, 2027
`INSULIN GLARGINE RECOMBINANT - LANTUS SOLOSTAR
`N 021081 002 8512297
`Sep 15, 2024
`8556864
`Mar 03, 2024
`8603044
`Mar 02, 2024
`8679069
`Apr 12, 2025
`8992486
`Jun 05, 2024
`9011391
`Mar 26, 2024
`9233211
`Mar 02, 2024
`9408979
`Mar 02, 2024
`9526844
`Mar 02, 2024
`9533105
`Aug 17, 2024
`9561331
`Aug 28, 2024
`9604008
`Mar 02, 2024
`9604009
`Aug 16, 2024
`9610409
`Mar 02, 2024
`9623189
`Aug 19, 2024
`9717852
`Apr 08, 2033
`9775954
`Mar 02, 2024
`9827379
`Mar 02, 2024
`INSULIN GLARGINE RECOMBINANT - TOUJEO SOLOSTAR
`N 206538 001 7918833
`Sep 23, 2027
`7918833*PED
`Mar 23, 2028
`8512297
`Sep 15, 2024
`8556864
`Mar 03, 2024
`8603044
`Mar 02, 2024
`8679069
`Apr 12, 2025
`8992486
`Jun 05, 2024
`9011391
`Mar 26, 2024
`9233211
`Mar 02, 2024
`9345750
`May 18, 2031
`9408979
`Mar 02, 2024
`9526844
`Mar 02, 2024
`9533105
`Aug 17, 2024
`9561331
`Aug 28, 2024
`9604008
`Mar 02, 2024
`9604009
`Aug 16, 2024
`9610409
`Mar 02, 2024
`9623189
`Aug 19, 2024
`9775954
`Mar 02, 2024
`9827379
`Mar 02, 2024
`INSULIN GLARGINE RECOMBINANT - TOUJEO MAX SOLOSTAR
`N 206538 002 7918833
`Sep 23, 2027
`8512297
`Sep 15, 2024
`8556864
`Mar 03, 2024
`8603044
`Mar 02, 2024
`8679069
`Apr 12, 2025
`8992486
`Jun 05, 2024
`9011391
`Mar 26, 2024
`9233211
`Mar 02, 2024
`9345750
`May 18, 2031
`9408979
`Mar 02, 2024
`9526844
`Mar 02, 2024
`9533105
`Aug 17, 2024
`9561331
`Aug 28, 2024
`9604008
`Mar 02, 2024
`9604009
`Aug 16, 2024
`
`PATENT
`CODES
`
`PATENT
`DELIST
`REQUESTED
`
`EXCLUSIVITY
`CODE(S)
`
`EXCLUSIVITY
`EXPIRATION
`DATE
`
`DP
`DP
`DP
`DP
`DP
`
`DP
`DP
`DP
`
`U-1832
`
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP U-2146
`
`DP
`DP
`DP
`DP
`DP
`DP
`U-1832
`DP
`DP U-1855
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP U-2146
`
`DP
`DP
`DP
`DP
`DP
`DP
`DP U-1832
`DP
`DP U-1855
`DP
`DP
`DP
`DP
`DP
`DP
`
`Mylan Ex.1062 - Page 5 of 5
`Mylan v. Sanofi - IPR2018-01676
`
`
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