`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` APPROVED
`
` DRUG
`
`PRODUCTS
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` WITH
`
`
`
` THERAPEUTIC
`
` EQUIVALENCE
`
` EVALUATIONS
` 44th 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
`
`
`
`
`
`
` 2024
`
`
`
`MPI EXHIBIT 1101 PAGE 1
`
`MPI EXHIBIT 1101 PAGE 1
`
`
`
` 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, 2023.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 44th 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
`
`
`
`
`
` 2024
`
`
`
`
`
`
`
`
`
`
`
`
`
`MPI EXHIBIT 1101 PAGE 2
`
`MPI EXHIBIT 1101 PAGE 2
`
`
`
`44TH EDITION - 2024 - APPROVED DRUG PRODUCT LIST
`ADA 374 of 442
`PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
`APPL/PROD
`PATENT
`PATENT
`NO
`EXPIRATION
`DELIST
`DATE
`REQUESTED
`
`EXCLUSIVITY
`CODE(S)
`
`EXCLUSIVITY
`EXPIRATION
`DATE
`
`PATENT NO
`
`PATENT
`CODES
`
`SELPERCATINIB - RETEVMO
`N 213246 002 10172851
`10172851
`10172851
`10584124
`10584124
`10584124
`10584124
`10584124
`10584124
`10584124
`10786489
`10786489
`10786489
`10786489
`10786489
`10786489
`10786489
`10786489
`10786489
`10786489
`10786489
`
`SELUMETINIB SULFATE - KOSELUGO
`N 213756 001 11813246
`7425637
`9156795
`9562017
`
`SELUMETINIB SULFATE - KOSELUGO
`N 213756 002 11813246
`7425637
`9156795
`9562017
`
`SEMAGLUTIDE - OZEMPIC
`N 209637 001 10220155
`10335462
`10357616
`10376652
`11097063
`11311679
`11446443
`7762994
`8114833
`8129343
`8536122
`8684969
`8920383
`9108002
`9132239
`9457154
`
`Oct 10, 2037
`Oct 10, 2037
`Oct 10, 2037
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`Oct 10, 2038
`
`Mar 26, 2029
`Mar 13, 2024
`Dec 12, 2026
`Dec 12, 2026
`
`Mar 26, 2029
`Mar 13, 2024
`Dec 12, 2026
`Dec 12, 2026
`
`Jul 17, 2026
`Jun 21, 2033
`Jan 20, 2026
`Jan 20, 2026
`Jul 17, 2026
`Jan 20, 2026
`Oct 20, 2025
`May 23, 2024
`Aug 13, 2025
`Dec 05, 2031
`Mar 20, 2026
`Oct 20, 2025
`Jul 17, 2026
`Jan 20, 2026
`Feb 01, 2032
`Sep 27, 2027
`
`DS
`DS
`DS
`DS
`DS
`DS
`DS
`
`U-2826
`U-2827
`U-2828
`U-2826
`U-2827
`U-2828
`U-3450
`U-3451
`U-3452
`U-3453
`DP U-2971
`DP U-2972
`DP U-2973
`DP U-2974
`DP U-2975
`DP U-2976
`DP U-2977
`DP U-3450
`DP U-3451
`DP U-3452
`DP U-3453
`
`DP
`
`DS
`DS DP
`DS
`
`DP
`
`DS
`DS DP
`DS
`
`U-2800
`
`U-2800
`
`DP
`
`U-2580
`
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DS DP U-2202
`DS DP U-2202
`DP
`DP
`DP
`DP
`DP
`
`NCE
`ODE-288
`
`Apr 10, 2025
`Apr 10, 2027
`
`NCE
`ODE-288
`
`Apr 10, 2025
`Apr 10, 2027
`
`MPI EXHIBIT 1101 PAGE 3
`
`MPI EXHIBIT 1101 PAGE 3
`
`
`
`44TH EDITION - 2024 - APPROVED DRUG PRODUCT LIST
`ADA 375 of 442
`PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
`APPL/PROD
`PATENT
`PATENT
`NO
`EXPIRATION
`DELIST
`DATE
`REQUESTED
`
`EXCLUSIVITY
`CODE(S)
`
`EXCLUSIVITY
`EXPIRATION
`DATE
`
`PATENT NO
`
`PATENT
`CODES
`
`SEMAGLUTIDE - OZEMPIC
`N 209637 001 9616180
`9687611
`9775953
`9861757
`RE46363
`
`SEMAGLUTIDE - OZEMPIC
`N 209637 002 10220155
`10335462
`10357616
`10376652
`11097063
`11311679
`11446443
`7762994
`8114833
`8129343
`8536122
`8684969
`8920383
`9108002
`9132239
`9457154
`9616180
`9687611
`9775953
`9861757
`RE46363
`
`SEMAGLUTIDE - OZEMPIC
`N 209637 003 10220155
`10357616
`10376652
`11097063
`11311679
`11446443
`7762994
`8114833
`8129343
`8536122
`8684969
`8920383
`9108002
`9132239
`9457154
`9616180
`9687611
`9775953
`9861757
`RE46363
`
`Jan 20, 2026
`Feb 27, 2027
`Jul 17, 2026
`Jan 20, 2026
`Aug 03, 2026
`
`Jul 17, 2026
`Jun 21, 2033
`Jan 20, 2026
`Jan 20, 2026
`Jul 17, 2026
`Jan 20, 2026
`Oct 20, 2025
`May 23, 2024
`Aug 13, 2025
`Dec 05, 2031
`Mar 20, 2026
`Oct 20, 2025
`Jul 17, 2026
`Jan 20, 2026
`Feb 01, 2032
`Sep 29, 2027
`Jan 20, 2026
`Feb 27, 2027
`Jul 17, 2026
`Jan 20, 2026
`Aug 03, 2026
`
`Jul 17, 2026
`Jan 20, 2026
`Jan 20, 2026
`Jul 17, 2026
`Jan 20, 2026
`Oct 20, 2025
`May 23, 2024
`Aug 13, 2025
`Dec 05, 2031
`Mar 20, 2026
`Oct 20, 2025
`Jul 17, 2026
`Jan 20, 2026
`Feb 01, 2032
`Sep 29, 2027
`Jan 20, 2026
`Feb 27, 2027
`Jul 17, 2026
`Jan 20, 2026
`Aug 03, 2026
`
`DP
`DP
`DP
`DP
`DP
`
`DP
`
`U-2580
`
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DS DP U-2202
`DS DP U-2202
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DS DP U-3355
`DS DP U-3355
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`
`D-185
`
`Mar 28, 2025
`
`MPI EXHIBIT 1101 PAGE 4
`
`MPI EXHIBIT 1101 PAGE 4
`
`
`
`44TH EDITION - 2024 - APPROVED DRUG PRODUCT LIST
`ADA 376 of 442
`PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
`APPL/PROD
`PATENT
`PATENT
`NO
`EXPIRATION
`DELIST
`DATE
`REQUESTED
`
`EXCLUSIVITY
`CODE(S)
`
`EXCLUSIVITY
`EXPIRATION
`DATE
`
`PATENT NO
`
`PATENT
`CODES
`
`SEMAGLUTIDE - OZEMPIC
`N 209637 004 10220155
`10335462
`10357616
`10376652
`11097063
`11311679
`11446443
`7762994
`8114833
`8129343
`8536122
`8684969
`8920383
`9108002
`9132239
`9457154
`9616180
`9687611
`9775953
`9861757
`RE46363
`
`SEMAGLUTIDE - RYBELSUS
`N 213051 001 10086047
`10278923
`10933120
`10960052
`11382957
`11759501
`11759502
`11759503
`8129343
`8536122
`9278123
`
`SEMAGLUTIDE - RYBELSUS
`N 213051 002 10086047
`10278923
`10933120
`10960052
`11382957
`11759501
`11759502
`11759503
`8129343
`8536122
`9278123
`
`SEMAGLUTIDE - RYBELSUS
`N 213051 003 10086047
`10278923
`
`Jul 17, 2026
`Jun 21, 2033
`Jan 20, 2026
`Jan 20, 2026
`Jul 17, 2026
`Jan 20, 2026
`Oct 20, 2025
`May 23, 2024
`Aug 13, 2025
`Dec 05, 2031
`Mar 20, 2026
`Oct 20, 2025
`Jul 17, 2026
`Jan 20, 2026
`Feb 01, 2032
`Sep 29, 2027
`Jan 20, 2026
`Feb 27, 2027
`Jul 17, 2026
`Jan 20, 2026
`Aug 03, 2026
`
`Dec 16, 2031
`May 02, 2034
`Mar 15, 2033
`Dec 16, 2031
`Dec 16, 2031
`Mar 15, 2033
`Mar 15, 2033
`Mar 15, 2033
`Dec 05, 2031
`Mar 20, 2026
`Dec 16, 2031
`
`Dec 16, 2031
`May 02, 2034
`Mar 15, 2033
`Dec 16, 2031
`Dec 16, 2031
`Mar 15, 2033
`Mar 15, 2033
`Mar 15, 2033
`Dec 05, 2031
`Mar 20, 2026
`Dec 16, 2031
`
`DP
`DP U-2580
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DS DP U-3469
`DS DP U-3469
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`
`DP
`
`U-2628
`
`DP
`DP
`DP
`DP
`DP
`DP
`DS DP U-2628
`DS DP U-2628
`DP U-2628
`
`DP
`
`U-2628
`
`DP
`DP
`DP
`DP
`DP
`DP
`DS DP U-2628
`DS DP U-2628
`DP U-2628
`
`Dec 16, 2031
`May 02, 2034
`
`DP
`
`U-2628
`
`MPI EXHIBIT 1101 PAGE 5
`
`MPI EXHIBIT 1101 PAGE 5
`
`