Page 138 - Orange Book Cumulative Supplement 10 October 2012
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PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST - 32ND EDITION
                                                                                                                 A - 1
                 PATENT & EXCLUSIVITY DRUG PRODUCT        LIST    -   CUMULATIVE SUPPLEMENT  10  - October 2012
                                          See List footnote   for information regarding List content

                                                PATENT                     PATENT                   EXCLUSIVITY
                                              EXPIRATION      PATENT       DELIST    EXCLUSIVITY    EXPIRATION
               APPL/PROD                         DATE                    REQUESTED                     DATE
                   NO         PATENT NO                       CODES                    CODE(S)
             ABACAVIR SULFATE - ABACAVIR SULFATE
               A091294 001                                                               PC        Dec  16, 2012
             ACETYLCYSTEINE - ACETADOTE
               N021539 001     8148356      May  21, 2026     DP
             ACLIDINIUM BROMIDE - TUDORZA PRESSAIR
               N202450 001     5840279      Jun  21, 2016     DP                         NCE       Jul  23, 2017
                               6071498      Jun  21, 2016     DP
                               6681768      Aug  07, 2022     DP
                               6750226      Sep  05, 2020   DS DP U-1264
                               7078412      Jul  16, 2020   DS DP U-1263
                               8051851      Apr  22, 2027     DP

             ADAPALENE; BENZOYL PEROXIDE - EPIDUO
               N022320 001     8105618      Dec  23, 2022        U-1078
                               8129362      Jul  18, 2027        U-1078
                               8241649      Dec  23, 2022     DP
             ALBUMIN HUMAN - OPTISON
               N020899 001                                                               M-120     Aug  17, 2015
             ALBUTEROL SULFATE - PROAIR HFA
               N021457 001     6446627      Dec  18, 2017     DP
                               8132712      Sep  07, 2028     DP
             ALBUTEROL SULFATE - VENTOLIN HFA
               N020983 001     7832351      Jun  19, 2023     DP
                               7832351*PED  Dec  19, 2023
             ALCAFTADINE - LASTACAFT
               N022134 001   >A>   5468743  Nov  21, 2013   DS DP
             ALENDRONATE SODIUM - BINOSTO
               N202344 001     7488496      Aug  11, 2023   DS DP
                               7964212      Mar  06, 2023   DS DP

             ALISKIREN HEMIFUMARATE; VALSARTAN - VALTURNA
               N022217 001     8168616      Jul  05, 2025     DP
             ALISKIREN HEMIFUMARATE; VALSARTAN - VALTURNA
               N022217 002     8168616      Jul  05, 2025     DP
             ALVIMOPAN - ENTEREG
               N021775 001     8112290      Jul  31, 2030        U-1225
             AMBRISENTAN - LETAIRIS
               N022081 001     RE42462      Jul  29, 2018   DS

             AMBRISENTAN - LETAIRIS
               N022081 002     RE42462      Jul  29, 2018   DS
             AMINOLEVULINIC ACID HYDROCHLORIDE - LEVULAN
               N020965 001     8216289      May  01, 2018        U-289
             AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT
               N022314 001     8101599      May  16, 2023     DP
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