`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` APPROVED
`
`
` DRUG
`
`
`PRODUCTS
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` WITH
`
`
`
` THERAPEUTIC
`
`
` EQUIVALENCE
`
`
` EVALUATIONS
`
`
` 40th 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
`
`
`
`
`
`
`
`
` 2020
`
`
`
`
`
`
`MPI EXHIBIT 1135 PAGE 1
`
`
`
`40TH EDITION - 2020 - APPROVED DRUG PRODUCT LIST
`ADA 242 of 277
`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
`
`Sep 15, 2032
`Jul 26, 2032
`Jul 26, 2032
`
`Jul 17, 2026
`Jun 21, 2033
`Jan 20, 2026
`Jan 20, 2026
`Jan 02, 2022
`May 23, 2024
`Aug 13, 2025
`Jan 29, 2029
`Mar 20, 2026
`Jun 30, 2023
`Jan 02, 2022
`Oct 20, 2025
`Jul 17, 2026
`Jan 20, 2026
`Feb 01, 2032
`Sep 27, 2027
`Jan 02, 2022
`Jan 20, 2026
`Feb 27, 2027
`Jul 17, 2026
`Jan 20, 2026
`Aug 03, 2026
`
`Dec 16, 2031
`May 02, 2034
`Jan 29, 2029
`Mar 20, 2026
`Dec 16, 2031
`
`Dec 16, 2031
`May 02, 2034
`Jan 29, 2029
`Mar 20, 2026
`Dec 16, 2031
`
`PATENT NO
`SELEXIPAG - UPTRAVI
`N 207947 008 7205302
`8791122
`9173881
`9284280
`SELINEXOR - XPOVIO
`N 212306 001 8999996
`9079865
`9714226
`SEMAGLUTIDE - OZEMPIC
`N 209637 001 10220155
`10335462
`10357616
`10376652
`6899699
`7762994
`8114833
`8129343
`8536122
`8579869
`8672898
`8684969
`8920383
`9108002
`9132239
`9457154
`9486588
`9616180
`9687611
`9775953
`9861757
`RE46363
`SEMAGLUTIDE - RYBELSUS
`N 213051 001 10086047
`10278923
`8129343
`8536122
`9278123
`SEMAGLUTIDE - RYBELSUS
`N 213051 002 10086047
`10278923
`8129343
`8536122
`9278123
`SEMAGLUTIDE - RYBELSUS
`Dec 16, 2031
`N 213051 003 10086047
`May 02, 2034
`10278923
`Jan 29, 2029
`8129343
`Mar 20, 2026
`8536122
`Dec 16, 2031
`9278123
`SERTRALINE HYDROCHLORIDE - ZOLOFT
`N 020990 001 7067555*PED
`Apr 11, 2020
`SEVELAMER CARBONATE - RENVELA
`N 022127 001 7985418
`SEVELAMER CARBONATE - RENVELA
`N 022318 001 9095509
`SEVELAMER CARBONATE - RENVELA
`N 022318 002 9095509
`
`Oct 27, 2025
`
`Dec 06, 2030
`
`Dec 06, 2030
`
`PATENT
`DELIST
`REQUESTED
`
`EXCLUSIVITY
`CODE(S)
`
`EXCLUSIVITY
`EXPIRATION
`DATE
`
`NCE
`ODE-106
`
`Dec 21, 2020
`Dec 21, 2022
`
`NCE
`ODE-257
`
`Jul 03, 2024
`Jul 03, 2026
`
`NCE
`
`Dec 05, 2022
`
`NCE
`NP
`
`NCE
`NP
`
`NCE
`NP
`
`Dec 05, 2022
`Sep 20, 2022
`
`Dec 05, 2022
`Sep 20, 2022
`
`Dec 05, 2022
`Sep 20, 2022
`
`PATENT
`CODES
`
`DS DP U-1797
`DS DP
`U-1798
`U-1831
`
`DS DP
`DS DP
`
`U-2584
`
`U-2580
`
`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
`U-2628
`DS DP U-2628
`DS DP U-2628
`DP U-2628
`
`DP
`U-2628
`DS DP U-2628
`DS DP U-2628
`DP U-2628
`
`DP
`U-2628
`DS DP U-2628
`DS DP U-2628
`DP U-2628
`
`DP
`
`DP
`
`DP
`
`MPI EXHIBIT 1135 PAGE 2
`
`
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