`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` APPROVED
`
`
` DRUG
`
`
`PRODUCTS
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` WITH
`
`
`
` THERAPEUTIC
`
`
`
` EQUIVALENCE
`
`
` EVALUATIONS
`
` 38th 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
`
`
`
` 2018
`
`
`
`
`
`
`MPI EXHIBIT 1120 PAGE 1
`
`
`
`38TH EDITION - 2018 - APPROVED DRUG PRODUCT LIST
`ADA 151 of 259
`
`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
`M-176
`
`Aug 25, 2020
`Apr 22, 2019
`
`APPL/PROD
`NO
`
`DS DP
`
`U-803
`U-803
`U-803
`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
`U-802
`N 208026 001 8119648
`Aug 12, 2023
`DP U-1853
`8178541
`Aug 12, 2023
`U-1503
`8673927
`May 04, 2027
`DP
`8883805
`Nov 26, 2025
`DP
`9155705
`May 21, 2030
`DP U-1503
`9173859
`May 04, 2027
`DP
`9415016
`Apr 02, 2029
`DP U-1967
`9555001
`Mar 06, 2033
`DP U-1968
`9555001
`Mar 06, 2033
`LINAGLIPTIN; METFORMIN HYDROCHLORIDE - JENTADUETO XR
`N 208026 002 6488962
`Jun 20, 2020
`DP
`6890898
`Feb 02, 2019
`7078381
`Feb 02, 2019
`7407955
`May 02, 2025
`7459428
`Feb 02, 2019
`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 6004297
`Jan 28, 2019
`6268343
`Aug 22, 2022
`6458924
`Aug 22, 2017
`7235627
`Aug 22, 2017
`8114833
`Aug 13, 2025
`8846618
`Jun 27, 2022
`9265893
`Sep 23, 2032
`RE41956
`Jan 21, 2021
`RE43834
`Jan 28, 2019
`LIRAGLUTIDE RECOMBINANT - SAXENDA
`N 206321 001 6268343
`Aug 22, 2022
`6458924
`Aug 22, 2017
`6899699
`Jan 01, 2022
`7235627
`Aug 22, 2017
`8114833
`Aug 13, 2025
`8672898
`Jan 02, 2022
`8684969
`Oct 20, 2025
`8846618
`Jun 27, 2022
`8920383
`Jul 17, 2026
`
`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
`
`DP
`DS DP U-968
`DS DP U-968
`DS DP
`DP
`DP
`DP
`DP
`DP
`
`DS DP U-1255
`DS DP U-1255
`DP
`DS DP
`DP
`DP
`DP
`DP
`DP
`
`MPI EXHIBIT 1120 PAGE 2
`
`
`
`38TH EDITION - 2018 - APPROVED DRUG PRODUCT LIST
`ADA 152 of 259
`
`PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
`
`See report footnote for information regarding report content
`
`APPL/PROD
`NO
`
`PATENT
`EXPIRATION
`DATE
`
`PATENT NO
`LIRAGLUTIDE RECOMBINANT - SAXENDA
`
`N 206321 001 9108002
`Jan 26, 2026
`9132239
`Feb 01, 2032
`9457154
`Sep 27, 2027
`9486588
`Jan 02, 2022
`9687611
`Feb 27, 2027
`9775953
`Jul 17, 2026
`RE46363
`Aug 03, 2026
`LISDEXAMFETAMINE DIMESYLATE - VYVANSE
`
`N 021977 001 7105486
`Feb 24, 2023
`7223735
`Feb 24, 2023
`7655630
`Feb 24, 2023
`7659253
`Feb 24, 2023
`7659254
`Feb 24, 2023
`7662787
`Feb 24, 2023
`7662788
`Feb 24, 2023
`7671030
`Feb 24, 2023
`7671031
`Feb 24, 2023
`7674774
`Feb 24, 2023
`7678770
`Feb 24, 2023
`7678771
`Feb 24, 2023
`7687466
`Feb 24, 2023
`7687467
`Feb 24, 2023
`7700561
`Feb 24, 2023
`7713936
`Feb 24, 2023
`7718619
`Feb 24, 2023
`7723305
`Feb 24, 2023
`LISDEXAMFETAMINE DIMESYLATE - VYVANSE
`
`N 021977 002 7105486
`Feb 24, 2023
`7223735
`Feb 24, 2023
`7655630
`Feb 24, 2023
`7659253
`Feb 24, 2023
`7659254
`Feb 24, 2023
`7662787
`Feb 24, 2023
`7662788
`Feb 24, 2023
`7671030
`Feb 24, 2023
`7671031
`Feb 24, 2023
`7674774
`Feb 24, 2023
`7678770
`Feb 24, 2023
`7678771
`Feb 24, 2023
`7687466
`Feb 24, 2023
`7687467
`Feb 24, 2023
`7700561
`Feb 24, 2023
`7713936
`Feb 24, 2023
`7718619
`Feb 24, 2023
`7723305
`Feb 24, 2023
`LISDEXAMFETAMINE DIMESYLATE - VYVANSE
`
`N 021977 003 7105486
`Feb 24, 2023
`7223735
`Feb 24, 2023
`7655630
`Feb 24, 2023
`7659253
`Feb 24, 2023
`7659254
`Feb 24, 2023
`7662787
`Feb 24, 2023
`7662788
`Feb 24, 2023
`7671030
`Feb 24, 2023
`7671031
`Feb 24, 2023
`7674774
`Feb 24, 2023
`7678770
`Feb 24, 2023
`7678771
`Feb 24, 2023
`7687466
`Feb 24, 2023
`7687467
`Feb 24, 2023
`7700561
`Feb 24, 2023
`7713936
`Feb 24, 2023
`7718619
`Feb 24, 2023
`7723305
`Feb 24, 2023
`
`PATENT
`CODES
`
`PATENT
`DELIST
`REQUESTED
`
`EXCLUSIVITY
`CODE(S)
`
`EXCLUSIVITY
`
`EXPIRATION
`
`DATE
`
`
`I-703
`M-188
`
`Jan 30, 2018
`
`Oct 14, 2019
`
`
`I-703
`M-188
`
`Jan 30, 2018
`
`Oct 14, 2019
`
`
`I-703
`M-188
`
`Jan 30, 2018
`
`Oct 14, 2019
`
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`
`U-727
`
`DP
`DS
`
`DS DP U-727
`
`U-1034
`
`DS
`
`U-727
`
`DP U-727
`
`U-727
`
`DP U-842
`
`U-842
`
`DP U-842
`
`DP
`
`DP U-842
`
`DP
`
`U-727
`
`DP U-842
`
`DP U-842
`
`
`U-727
`
`DP
`DS
`
`DS DP U-727
`
`U-1034
`
`DS
`
`U-727
`
`DP U-727
`
`U-727
`
`DP U-842
`
`U-842
`
`DP U-842
`
`DP
`
`DP U-842
`
`DP
`
`U-727
`
`DP U-842
`
`DP U-842
`
`
`U-727
`
`DP
`DS
`
`DS DP U-727
`
`U-1034
`
`DS
`
`U-727
`
`DP U-727
`
`U-727
`
`DP U-842
`
`U-842
`
`DP U-842
`
`DP
`
`DP U-842
`
`DP
`
`U-727
`
`DP U-842
`
`DP U-842
`
`
`MPI EXHIBIT 1120 PAGE 3
`
`
`
`38TH EDITION - 2018 - APPROVED DRUG PRODUCT LIST
`ADA 225 of 259
`PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
`See report footnote for information regarding report content
`
`APPL/PROD
`NO
`
`PATENT
`EXPIRATION
`DATE
`
`Apr 04, 2023
`Aug 01, 2030
`Aug 12, 2029
`Jun 25, 2030
`
`Apr 04, 2023
`Aug 01, 2030
`Aug 12, 2029
`Jun 25, 2030
`
`Apr 04, 2023
`Aug 01, 2030
`Aug 12, 2029
`Jun 25, 2030
`
`PATENT NO
`SELEXIPAG - UPTRAVI
`N 207947 001 7205302
`8791122
`9173881
`9284280
`SELEXIPAG - UPTRAVI
`N 207947 002 7205302
`8791122
`9173881
`9284280
`SELEXIPAG - UPTRAVI
`N 207947 003 7205302
`8791122
`9173881
`9284280
`SELEXIPAG - UPTRAVI
`N 207947 004 7205302
`8791122
`9173881
`9284280
`SELEXIPAG - UPTRAVI
`N 207947 005 7205302
`8791122
`9173881
`9284280
`SELEXIPAG - UPTRAVI
`N 207947 006 7205302
`8791122
`9173881
`9284280
`SELEXIPAG - UPTRAVI
`N 207947 007 7205302
`8791122
`9173881
`9284280
`SELEXIPAG - UPTRAVI
`N 207947 008 7205302
`8791122
`9173881
`9284280
`SEMAGLUTIDE - OZEMPIC
`Jan 02, 2022
`N 209637 001 6899699
`May 23, 2024
`7762994
`Aug 13, 2025
`8114833
`Jan 29, 2029
`8129343
`Mar 20, 2026
`8536122
`Jun 30, 2023
`8579869
`Jan 02, 2022
`8672898
`Oct 20, 2025
`8684969
`Jul 17, 2026
`8920383
`Jan 20, 2026
`9108002
`Feb 01, 2032
`9132239
`Sep 27, 2027
`9457154
`Jan 02, 2022
`9486588
`Feb 27, 2027
`9687611
`Jul 17, 2026
`9775953
`Aug 03, 2026
`RE46363
`SERTRALINE HYDROCHLORIDE - ZOLOFT
`N 020990 001 6727283
`Oct 11, 2019
`7067555
`Oct 11, 2019
`7067555*PED
`Apr 11, 2020
`
`Apr 04, 2023
`Aug 01, 2030
`Aug 12, 2029
`Jun 25, 2030
`
`Apr 04, 2023
`Aug 01, 2030
`Aug 12, 2029
`Jun 25, 2030
`
`Apr 04, 2023
`Aug 01, 2030
`Aug 12, 2029
`Jun 25, 2030
`
`Apr 04, 2023
`Aug 01, 2030
`Aug 12, 2029
`Jun 25, 2030
`
`Apr 04, 2023
`Aug 01, 2030
`Aug 12, 2029
`Jun 25, 2030
`
`PATENT
`DELIST
`REQUESTED
`
`EXCLUSIVITY
`CODE(S)
`
`EXCLUSIVITY
`EXPIRATION
`DATE
`
`NCE
`ODE-106
`
`Dec 21, 2020
`Dec 21, 2022
`
`NCE
`ODE-106
`
`Dec 21, 2020
`Dec 21, 2022
`
`NCE
`ODE-106
`
`Dec 21, 2020
`Dec 21, 2022
`
`NCE
`ODE-106
`
`Dec 21, 2020
`Dec 21, 2022
`
`NCE
`ODE-106
`
`Dec 21, 2020
`Dec 21, 2022
`
`NCE
`ODE-106
`
`Dec 21, 2020
`Dec 21, 2022
`
`NCE
`ODE-106
`
`Dec 21, 2020
`Dec 21, 2022
`
`NCE
`ODE-106
`
`Dec 21, 2020
`Dec 21, 2022
`
`NCE
`
`Dec 05, 2022
`
`PATENT
`CODES
`
`DS DP U-1797
`DS DP
`U-1798
`U-1831
`
`DS DP U-1797
`DS DP
`U-1798
`U-1831
`
`DS DP U-1797
`DS DP
`U-1798
`U-1831
`
`DS DP U-1797
`DS DP
`U-1798
`U-1831
`
`DS DP U-1797
`DS DP
`U-1798
`U-1831
`
`DS DP U-1797
`DS DP
`U-1798
`U-1831
`
`DS DP U-1797
`DS DP
`U-1798
`U-1831
`
`DS DP U-1797
`DS DP
`U-1798
`U-1831
`
`DP
`DP
`DP
`DS DP U-2202
`DS DP U-2202
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`
`DP U-580
`DP
`
`MPI EXHIBIT 1120 PAGE 4
`
`
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