`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` APPROVED
`
`
` DRUG
`
`
`PRODUCTS
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` WITH
`
`
`
`
` THERAPEUTIC
`
`
` EQUIVALENCE
`
`
` EVALUATIONS
`
` 35th 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 MEDICAL PRODUCTS AND TOBACCO
` OFFICE OF GENERIC DRUGS
`
`
`
`
` 2015
`
`
`
`
`West-Ward Exhibit 1029
`2015 Orange Book-AFINITOR
`Page 001
`
`
`
`35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
`ADA 77 of 229
`
`PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
`
`See report footnote for information regarding report content
`
`APPL/PROD
`
`NO
`
`PATENT NO
`
`
`EVEROLIMUS - AFINITOR
`
`N 022334 001 5665772
`
`6004973
`
`7297703
`
`7741338
`
`8410131
`
`8410131*PED
`
`8436010
`
`8436010*PED
`
`8778962
`
`8778962*PED
`
`
`EVEROLIMUS - AFINITOR
`
`N 022334 002 5665772
`
`6004973
`
`7297703
`
`7741338
`
`8410131
`
`8410131*PED
`
`8436010
`
`8436010*PED
`
`8778962
`
`8778962*PED
`
`
`EVEROLIMUS - AFINITOR
`
`N 022334 003 5665772
`
`6004973
`
`7297703
`
`7741338
`
`8410131
`
`8410131*PED
`
`8436010
`
`8436010*PED
`
`8778962
`
`8778962*PED
`
`
`EVEROLIMUS - AFINITOR
`
`N 022334 004 5665772
`
`6004973
`
`7297703
`
`7741338
`
`8410131
`
`8410131*PED
`
`8436010
`
`8436010*PED
`
`8778962
`
`8778962*PED
`
`
`PATENT
`
`EXPIRATION
`
`DATE
`
`
`Sep 09, 2019
`
`Jul 12, 2016
`
`Dec 06, 2019
`
`Dec 06, 2019
`
`May 22, 2025
`
`Nov 22, 2025
`
`Feb 22, 2022
`
`Aug 22, 2022
`
`Feb 18, 2022
`
`Aug 18, 2022
`
`
`Sep 09, 2019
`
`Jul 12, 2016
`
`Dec 06, 2019
`
`Dec 06, 2019
`
`May 22, 2025
`
`Nov 22, 2025
`
`Feb 22, 2022
`
`Aug 22, 2022
`
`Feb 18, 2022
`
`Aug 18, 2022
`
`
`Sep 09, 2019
`
`Jul 12, 2016
`
`Dec 06, 2019
`
`Dec 06, 2019
`
`May 22, 2025
`
`Nov 22, 2025
`
`Feb 22, 2022
`
`Aug 22, 2022
`
`Feb 18, 2022
`
`Aug 18, 2022
`
`
`Sep 09, 2019
`
`Jul 12, 2016
`
`Dec 06, 2019
`
`Dec 06, 2019
`
`May 22, 2025
`
`Nov 22, 2025
`
`Feb 22, 2022
`
`Aug 22, 2022
`
`Feb 18, 2022
`
`Aug 18, 2022
`
`
`PATENT
`CODES
`
`PATENT
`DELIST
`REQUESTED
`
`EXCLUSIVITY
`CODE(S)
`
`DS DP
`DP
`DP
`DP
`DS DP U-1368
`DS DP U-1396
`U-1541
`
`DS DP
`DP
`DP
`DP
`DS DP U-1368
`DS DP U-1396
`U-1541
`
`DS DP
`DP
`DP
`DP
`DS DP U-1368
`DS DP U-1396
`U-1541
`
`DS DP
`DP
`DP
`DP
`DS DP U-1368
`DS DP U-1396
`U-1541
`
`I-650
`I-655
`ODE
`ODE
`ODE
`PED
`PED
`PED
`PED
`PED
`PED
`
`I-650
`I-655
`ODE
`ODE
`ODE
`PED
`PED
`PED
`PED
`PED
`PED
`
`I-650
`I-655
`ODE
`ODE
`ODE
`PED
`PED
`PED
`PED
`PED
`PED
`
`I-650
`I-655
`ODE
`ODE
`ODE
`PED
`PED
`PED
`PED
`PED
`PED
`
`EXCLUSIVITY
`
`EXPIRATION
`
`DATE
`
`
`Apr 26, 2015
`
`Jul 20, 2015
`
`Oct 29, 2017
`
`May 05, 2018
`
`Apr 26, 2019
`
`Sep 30, 2014
`
`Nov 05, 2014
`
`Oct 26, 2015
`
`Apr 29, 2018
`
`Nov 05, 2018
`
`Oct 26, 2019
`
`
`Apr 26, 2015
`
`Jul 20, 2015
`
`Oct 29, 2017
`
`May 05, 2018
`
`Apr 26, 2019
`
`Sep 30, 2014
`
`Nov 05, 2014
`
`Oct 26, 2015
`
`Apr 29, 2018
`
`Nov 05, 2018
`
`Oct 26, 2019
`
`
`Apr 26, 2015
`
`Jul 20, 2015
`
`Oct 29, 2017
`
`May 05, 2018
`
`Apr 26, 2019
`
`Sep 30, 2014
`
`Nov 05, 2014
`
`Oct 26, 2015
`
`Apr 29, 2018
`
`Nov 05, 2018
`
`Oct 26, 2019
`
`
`Apr 26, 2015
`
`Jul 20, 2015
`
`Oct 29, 2017
`
`May 05, 2018
`
`Apr 26, 2019
`
`Sep 30, 2014
`
`Nov 05, 2014
`
`Oct 26, 2015
`
`Apr 29, 2018
`
`Nov 05, 2018
`
`Oct 26, 2019
`
`
`West-Ward Exhibit 1029
`2015 Orange Book-AFINITOR
`Page 002
`
`
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