`
`
`
`
`
`
`
`
`
` CUMULATIVE
`
` SUPPLEMENT 12
`
` DECEMBER 2017
`
`
`
`APPROVED
`
`
`DRUG PRODUCTS
`
`
`
`
`WITH
`
`
`
`THERAPEUTIC EQUIVALENCE EVALUATIONS
`
`
`
`
`37th EDITION
`
`
` 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
`
`
`
`2017
`
`
`
`
`
`
`
`MPI EXHIBIT 1133 PAGE 1
`
`
`
`PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2017
`See List footnote for information regarding List content
`
`APPL/PROD
`NO
`
`PATENT NO
`
`PATENT
`EXPIRATION
`DATE
`
`PATENT
`CODES
`
`PATENT
`DELIST
`REQUESTED
`
`EXCLUSIVITY
`CODE(S)
`
`EXCLUSIVITY
`EXPIRATION
`DATE
`
`A - 69
`
`>A> NCE
`
`Dec 05, 2022
`
`>A> PC
`
`>A> PC
`
`>A> PC
`
`Jun 09, 2018
`
`Jun 09, 2018
`
`Jun 09, 2018
`
`SEMAGLUTIDE - OZEMPIC
`N 209637 001 >A> 6899699
`>A> 7762994
`>A> 8114833
`>A> 8129343
`>A> 8536122
`>A> 8579869
`>A> 8672898
`>A> 8684969
`>A> 8920383
`>A> 9108002
`>A> 9132239
`>A> 9457154
`>A> 9486588
`>A> 9687611
`>A> 9775953
`>A> RE46363
`
`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
`Feb 27, 2027
`Jul 17, 2026
`Aug 03, 2026
`
`DP
`DP
`DP
`DS DP U-2202
`DS DP U-2202
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`DP
`
`SILDENAFIL CITRATE - SILDENAFIL CITRATE
`A 077342 001
`
`SILDENAFIL CITRATE - SILDENAFIL CITRATE
`A 077342 002
`
`SILDENAFIL CITRATE - SILDENAFIL CITRATE
`A 077342 003
`
`SIMEPREVIR SODIUM - OLYSIO
`N 205123 001
`9623022
`
`SIMVASTATIN - FLOLIPID
`N 206679 001
`9597289
`
`SIMVASTATIN - FLOLIPID
`N 206679 002
`9597289
`
`SINECATECHINS - VEREGEN
`N 021902 001
`9770406
`
`SITAGLIPTIN PHOSPHATE - JANUVIA
`N 021995 001
`6303661
`6890898
`7078381
`7459428
`
`SITAGLIPTIN PHOSPHATE - JANUVIA
`N 021995 002
`6303661
`6890898
`7078381
`7459428
`
`SITAGLIPTIN PHOSPHATE - JANUVIA
`N 021995 003
`6303661
`6890898
`7078381
`7459428
`
`Jul 28, 2026
`
`U-1467
`
`Feb 23, 2030
`
`Feb 23, 2030
`
`DP
`
`DP
`
`Jul 12, 2025
`
`DP U-172
`
`Apr 24, 2017
`Feb 02, 2019
`Feb 02, 2019
`Feb 02, 2019
`
`Apr 24, 2017
`Feb 02, 2019
`Feb 02, 2019
`Feb 02, 2019
`
`Apr 24, 2017
`Feb 02, 2019
`Feb 02, 2019
`Feb 02, 2019
`
`U-1996
`U-1997
`U-1997
`U-1945
`
`U-1996
`U-1997
`U-1997
`U-1945
`
`U-1996
`U-1997
`U-1997
`U-1945
`
`SODIUM NITRITE; SODIUM THIOSULFATE - NITHIODOTE
`N 201444 001
`9345724
`Mar 29, 2031
`9585912
`Mar 29, 2031
`
`DS DP U-2015
`DS DP
`
`MPI EXHIBIT 1133 PAGE 2
`
`