`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` APPROVED
`
`
` DRUG
`
`
`PRODUCTS
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` WITH
`
`
`
` THERAPEUTIC
`
`
` EQUIVALENCE
`
`
` EVALUATIONS
`
`
` 39th 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
`
`
`
` 2019
`
`
`
`
`
`
`
`
`
`
`MPI EXHIBIT 1134 PAGE 1
`
`
`
`39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST
`ADA 229 of 263
`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
`SAXAGLIPTIN HYDROCHLORIDE - ONGLYZA
`7951400
`Nov 30, 2028
`N 022350 001
`RE44186
`Jul 31, 2023
`RE44186
`Jul 31, 2023
`SAXAGLIPTIN HYDROCHLORIDE - ONGLYZA
`7951400
`Nov 30, 2028
`N 022350 002
`RE44186
`Jul 31, 2023
`RE44186
`Jul 31, 2023
`SECNIDAZOLE - SOLOSEC
`N 209363 001
`
`SELEXIPAG - UPTRAVI
`7205302
`N 207947 001
`8791122
`9173881
`9284280
`SELEXIPAG - UPTRAVI
`7205302
`N 207947 002
`8791122
`9173881
`9284280
`SELEXIPAG - UPTRAVI
`7205302
`N 207947 003
`8791122
`9173881
`9284280
`SELEXIPAG - UPTRAVI
`7205302
`N 207947 004
`8791122
`9173881
`9284280
`SELEXIPAG - UPTRAVI
`7205302
`N 207947 005
`8791122
`9173881
`9284280
`SELEXIPAG - UPTRAVI
`7205302
`N 207947 006
`8791122
`9173881
`9284280
`SELEXIPAG - UPTRAVI
`7205302
`N 207947 007
`8791122
`9173881
`9284280
`SELEXIPAG - UPTRAVI
`7205302
`N 207947 008
`8791122
`9173881
`9284280
`SEMAGLUTIDE - OZEMPIC
`6899699
`N 209637 001
`7762994
`8114833
`8129343
`8536122
`8579869
`8672898
`
`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
`
`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
`
`Jan 02, 2022
`May 23, 2024
`Aug 13, 2025
`Jan 29, 2029
`Mar 20, 2026
`Jun 30, 2023
`Jan 02, 2022
`
`PATENT
`DELIST
`REQUESTED
`
`EXCLUSIVITY
`CODE(S)
`
`M-175
`M-198
`
`M-175
`M-198
`
`NCE
`GAIN
`
`EXCLUSIVITY
`EXPIRATION
`DATE
`
`Apr 05, 2019
`
`Feb 27, 2020
`
`Apr 05, 2019
`
`Feb 27, 2020
`
`Sep 15, 2022
`
`Sep 15, 2027
`
`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
`
`DP
`DS DP U-1837
`DS DP U-995
`
`DP
`DS DP U-1837
`DS DP U-995
`
`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
`
`MPI EXHIBIT 1134 PAGE 2
`
`
`
`39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST
`ADA 230 of 263
`PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
`See report footnote for information regarding report content
`
`APPL/PROD
`NO
`
`PATENT
`EXPIRATION
`DATE
`
`Oct 27, 2025
`
`Dec 06, 2030
`
`PATENT NO
`SEMAGLUTIDE - OZEMPIC
`Oct 20, 2025
`N 209637 001 8684969
`Jul 17, 2026
`8920383
`Jan 20, 2026
`9108002
`Feb 01, 2032
`9132239
`Sep 27, 2027
`9457154
`Jan 02, 2022
`9486588
`Jan 20, 2026
`9616180
`Feb 27, 2027
`9687611
`Jul 17, 2026
`9775953
`Jan 20, 2026
`9861757
`Aug 03, 2026
`RE46363
`SERTRALINE HYDROCHLORIDE - ZOLOFT
`N 020990 001 6727283
`Oct 11, 2019
`7067555
`Oct 11, 2019
`7067555*PED
`Apr 11, 2020
`SEVELAMER CARBONATE - RENVELA
`N 022127 001 7985418
`SEVELAMER CARBONATE - RENVELA
`N 022318 001 9095509
`SEVELAMER CARBONATE - RENVELA
`Dec 06, 2030
`N 022318 002 9095509
`SEVELAMER HYDROCHLORIDE - RENAGEL
`N 021179 001 6733780
`Oct 18, 2020
`SEVELAMER HYDROCHLORIDE - RENAGEL
`N 021179 002 6733780
`Oct 18, 2020
`SILDENAFIL CITRATE - VIAGRA
`N 020895 001 6469012
`SILDENAFIL CITRATE - VIAGRA
`N 020895 002 6469012
`SILDENAFIL CITRATE - VIAGRA
`N 020895 003 6469012
`SIMEPREVIR SODIUM - OLYSIO
`N 205123 001 7671032
`8148399
`8349869
`8741926
`8754106
`9040562
`9353103
`9623022
`9856265
`SIMVASTATIN - FLOLIPID
`N 206679 001 9597289
`SIMVASTATIN - FLOLIPID
`Feb 23, 2030
`N 206679 002 9597289
`SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC
`N 202343 001 6699871
`Jul 26, 2022
`6890898
`Feb 02, 2019
`6890898
`Feb 02, 2019
`6890898
`Feb 02, 2019
`7078381
`Feb 02, 2019
`7125873
`Jul 26, 2022
`7125873
`Jul 26, 2022
`7125873
`Jul 26, 2022
`7125873
`Jul 26, 2022
`7326708
`Apr 11, 2026
`7459428
`Feb 02, 2019
`
`Oct 22, 2019
`
`Oct 22, 2019
`
`Oct 22, 2019
`
`May 19, 2025
`Sep 05, 2029
`Jul 28, 2026
`Jul 28, 2026
`Jul 28, 2026
`Jul 28, 2026
`Jul 28, 2026
`Jul 28, 2026
`Jul 28, 2026
`
`Feb 23, 2030
`
`PATENT
`CODES
`
`PATENT
`DELIST
`REQUESTED
`
`EXCLUSIVITY
`CODE(S)
`
`EXCLUSIVITY
`EXPIRATION
`DATE
`
`NPP
`
`NPP
`
`NPP
`
`Nov 25, 2019
`
`Nov 25, 2019
`
`Nov 25, 2019
`
`M-171
`M-179
`
`Feb 26, 2019
`May 20, 2019
`
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`
`DP U-580
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`U-155
`
`U-155
`
`U-155
`
`DS DP
`DS DP U-1467
`DS DP U-1467
`DS
`U-1467
`DS
`U-1467
`DS DP U-1467
`U-1467
`U-1467
`DS DP U-1467
`
`DP
`
`DP
`
`DS DP U-1188
`U-1189
`U-1190
`U-1191
`U-1188
`DP U-1189
`DP U-1190
`DP U-1192
`DP U-1193
`DS DP U-1188
`U-1189
`
`MPI EXHIBIT 1134 PAGE 3
`
`
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