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` APPROVED
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` DRUG
`
`PRODUCTS
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` WITH
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` THERAPEUTIC
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` EQUIVALENCE
`
` EVALUATIONS
` 44th EDITION
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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
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` CENTER FOR DRUG EVALUATION AND RESEARCH
`
`
` OFFICE OF GENERIC DRUGS
` OFFICE OF GENERIC DRUG POLICY
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` 2024
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`MPI EXHIBIT 1107 PAGE 1
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`MPI EXHIBIT 1107 PAGE 1
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` APPROVED DRUG PRODUCTS
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` with
` 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, 2023.
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` 44th EDITION
`
`
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`
` 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 1107 PAGE 2
`
`MPI EXHIBIT 1107 PAGE 2
`
`
`
`44TH EDITION - 2024 - APPROVED DRUG PRODUCT LIST
`ADA 377 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 - RYBELSUS
`N 213051 003 10933120
`10960052
`11382957
`11759501
`11759502
`11759503
`8129343
`8536122
`9278123
`
`SEMAGLUTIDE - WEGOVY
`N 215256 001 10888605
`11318191
`11752198
`8129343
`8536122
`9764003
`
`SEMAGLUTIDE - WEGOVY
`N 215256 002 10888605
`11318191
`11752198
`8129343
`8536122
`9764003
`
`SEMAGLUTIDE - WEGOVY
`N 215256 003 10888605
`11318191
`11752198
`8129343
`8536122
`9764003
`
`SEMAGLUTIDE - WEGOVY
`N 215256 004 10888605
`11318191
`11752198
`8129343
`8536122
`9764003
`
`SEMAGLUTIDE - WEGOVY
`N 215256 005 10888605
`11318191
`11752198
`8129343
`8536122
`9764003
`
`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
`
`Aug 24, 2038
`Feb 17, 2041
`Aug 24, 2038
`Dec 05, 2031
`Mar 20, 2026
`Jun 21, 2033
`
`Aug 24, 2038
`Feb 17, 2041
`Aug 24, 2038
`Dec 05, 2031
`Mar 20, 2026
`Jun 21, 2033
`
`Aug 24, 2038
`Feb 17, 2041
`Aug 24, 2038
`Dec 05, 2031
`Mar 20, 2026
`Jun 21, 2033
`
`Aug 24, 2038
`Feb 17, 2041
`Aug 24, 2038
`Dec 05, 2031
`Mar 20, 2026
`Jun 21, 2033
`
`Aug 24, 2038
`Feb 17, 2041
`Aug 24, 2038
`Dec 05, 2031
`Mar 20, 2026
`Jun 21, 2033
`
`DP
`DP
`DP
`DP
`DP
`DP
`DS DP U-2628
`DS DP U-2628
`DP U-2628
`
`DP U-3162
`DP U-3162
`DP U-3162
`DS DP
`DS DP
`
`U-3161
`
`DP U-3162
`DP U-3162
`DP U-3162
`DS DP
`DS DP
`
`U-3161
`
`DP U-3162
`DP U-3162
`DP U-3162
`DS DP
`DS DP
`
`U-3161
`
`DP U-3162
`DP U-3162
`DP U-3162
`DS DP
`DS DP
`
`U-3161
`
`DP U-3162
`DP U-3162
`DP U-3162
`DS DP
`DS DP
`
`U-3161
`
`NP
`NPP
`
`Jun 04, 2024
`Dec 23, 2025
`
`NP
`NPP
`
`Jun 04, 2024
`Dec 23, 2025
`
`NP
`NPP
`
`Jun 04, 2024
`Dec 23, 2025
`
`D-190
`NP
`NPP
`
`Jul 21, 2026
`Jun 04, 2024
`Dec 23, 2025
`
`NP
`NPP
`
`Jun 04, 2024
`Dec 23, 2025
`
`SETMELANOTIDE ACETATE - IMCIVREE
`N 213793 001 11129869
`8039435
`
`Jul 04, 2034
`Oct 13, 2027
`
`DP
`DS DP
`
`I-892
`NCE
`
`Jun 16, 2025
`Nov 25, 2025
`
`MPI EXHIBIT 1107 PAGE 3
`
`MPI EXHIBIT 1107 PAGE 3
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`