APPROVED
`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
`
`
`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
`Mylan v. Sanofi - IPR2018-01676
`
`
`
`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
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
