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` APPROVED
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` DRUG
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`PRODUCTS
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` WITH
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` THERAPEUTIC
`
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` EQUIVALENCE
`
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` EVALUATIONS
`
`
` 40th EDITION
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`
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` THE PRODUCTS IN THIS LIST HAVE BEEN APPROVED UNDER
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`SECTION 505 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.
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`
`
`
` U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`
` 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
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`
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`
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` 2020
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`MYLAN INST. EXHIBIT 1117 PAGE 1
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`MYLAN INST. EXHIBIT 1117 PAGE 1
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` APPROVED DRUG PRODUCTS
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` with
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` THERAPEUTIC EQUIVALENCE EVALUATIONS
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` The products in this list have been approved under section 505 of the
` Federal Food, Drug, and Cosmetic Act. This volume is current through
`
`
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` December 31, 2019.
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` 40th 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
`
`
`
`
`
` 2020
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`MYLAN INST. EXHIBIT 1117 PAGE 2
`
`MYLAN INST. EXHIBIT 1117 PAGE 2
`
`
`
`40TH EDITION - 2020 - APPROVED DRUG PRODUCT LIST
`ADA 165 of 277
`
`PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
`
`See report footnote for information regarding report content
`
`PATENT
`DELIST
`REQUESTED
`
`EXCLUSIVITY
`CODE(S)
`
`EXCLUSIVITY
`EXPIRATION
`DATE
`
`I-750
`NPP
`PED
`
`Aug 25, 2020
`Jun 17, 2022
`Dec 17, 2022
`
`APPL/PROD
`NO
`
`U-2339
`
`DP
`DS DP
`U-802
`DP U-1853
`U-1503
`DP
`DP
`DP U-1503
`DP
`DP U-1967
`DP U-1968
`
`Mar 15, 2021
`Jan 29, 2021
`
`DP
`
`DS
`
`PATENT
`EXPIRATION
`PATENT
`PATENT NO
`DATE
`CODES
`LINAGLIPTIN; METFORMIN HYDROCHLORIDE - JENTADUETO XR
`N 208026 001 8883805
`Nov 26, 2025
`DP
`9155705
`May 21, 2030
`DP
`9173859
`May 04, 2027
`DP U-1503
`9415016
`Apr 02, 2029
`DP
`9555001
`Mar 06, 2033
`DP U-1967
`9555001
`Mar 06, 2033
`DP U-1968
`LINAGLIPTIN; METFORMIN HYDROCHLORIDE - JENTADUETO XR
`N 208026 002 10022379
`Apr 02, 2029
`6488962
`Jun 20, 2020
`7407955
`May 02, 2025
`8119648
`Aug 12, 2023
`8178541
`Aug 12, 2023
`8673927
`May 04, 2027
`8883805
`Nov 26, 2025
`9155705
`May 21, 2030
`9173859
`May 04, 2027
`9415016
`Apr 02, 2029
`9555001
`Mar 06, 2033
`9555001
`Mar 06, 2033
`LINEZOLID - ZYVOX
`N 021130 001 6514529
`6559305
`LINEZOLID - ZYVOX
`N 021130 002 6514529
`6559305
`LINEZOLID - ZYVOX
`N 021131 001 6559305
`LINEZOLID - ZYVOX
`N 021131 002 6559305
`6559305*PED
`LINEZOLID - ZYVOX
`N 021131 003 6559305
`6559305*PED
`LINEZOLID - ZYVOX
`Jan 29, 2021
`N 021132 001 6559305
`LIRAGLUTIDE RECOMBINANT - VICTOZA
`N 022341 001 6268343
`Aug 22, 2022
`6268343*PED
`Feb 22, 2023
`7762994
`May 23, 2024
`7762994*PED
`Nov 23, 2024
`8114833
`Aug 13, 2025
`8114833*PED
`Feb 13, 2026
`8579869
`Jun 30, 2023
`8579869*PED
`Dec 30, 2023
`8846618
`Jun 27, 2022
`8846618*PED
`Dec 27, 2022
`9265893
`Sep 23, 2032
`9265893*PED
`Mar 23, 2033
`9968659
`Jan 09, 2037
`9968659*PED
`Jul 09, 2037
`RE41956
`Jan 21, 2021
`RE41956*PED
`Jul 21, 2021
`LIRAGLUTIDE RECOMBINANT - SAXENDA
`N 206321 001 10220155
`Jul 17, 2026
`10220155*PED
`Jan 17, 2027
`10357616
`Jan 20, 2026
`10376652
`Jan 20, 2026
`6268343
`Aug 22, 2022
`6268343*PED
`Feb 22, 2023
`6899699
`Jan 01, 2022
`
`Mar 15, 2021
`Jan 29, 2021
`
`Jan 29, 2021
`
`Jan 29, 2021
`Jul 29, 2021
`
`Jan 29, 2021
`Jul 29, 2021
`
`DP
`
`DS
`
`DS
`
`DS
`
`DS
`
`DS
`
`DS DP U-968
`DP
`DS DP
`DP
`DP
`DP
`
`U-2313
`
`DP
`
`DP
`DP
`DP
`DS DP U-1255
`DP
`
`MYLAN INST. EXHIBIT 1117 PAGE 3
`
`MYLAN INST. EXHIBIT 1117 PAGE 3
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`