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    Information, Expiry & Status of FDA Orange Book Patents covering Sapropterin Dihydrochloride

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    Sapropterin Dihydrochloride

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    01 BIOMARIN PHARM (42)

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    01 7566462 (1)

    02 7566462*PED (1)

    03 7566714 (3)

    04 7566714*PED (3)

    05 7612073 (3)

    06 7612073*PED (3)

    07 7727987 (1)

    08 7727987*PED (1)

    09 8003126 (1)

    10 8003126*PED (1)

    11 8067416 (3)

    12 8067416*PED (3)

    13 8318745 (1)

    14 8318745*PED (1)

    15 9216178 (2)

    16 9216178*PED (2)

    17 9433624 (3)

    18 9433624*PED (3)

    19 RE43797 (3)

    20 RE43797*PED (3)

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    01 2024-11-17 (17)

    02 2025-05-17 (17)

    03 2025-11-16 (2)

    04 2026-05-16 (2)

    05 2032-11-01 (2)

    06 2033-05-01 (2)

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    BIOMARIN PHARM

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      SAPROPTERIN DIHYDROCHLORIDE

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      8067416
      2024-11-17
      U-1589
      205065
      METHOD OF USE FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA
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        7566714
        2024-11-17
        U-1589
        205065
        METHOD OF USE FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA
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          RE43797
          2024-11-17
          U-1156
          22181
          TO REDUCE BLOOD PHENYLALANINE (PHE) LEVELS IN PATINETS WITH HYPERPHENYLALANINEMIA (HPA)
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            7566714
            2024-11-17
            U-1589
            205065
            METHOD OF USE FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA
            1
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              RE43797
              2024-11-17
              U-1590
              205065
              KUVAN IS INDICATED TO REDUCE BLOOD PHENYLALANINE LEVELS IN PATIENTS WITH HYPERPHENYLALANINEMIA
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                7566714
                2024-11-17
                U-989
                22181
                FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA
                1
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                  SAPROPTERIN DIHYDROCHLORIDE

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                  RE43797
                  2024-11-17
                  U-1590
                  205065
                  KUVAN IS INDICATED TO REDUCE BLOOD PHENYLALANINE LEVELS IN PATIENTS WITH HYPERPHENYLALANINEMIA
                  2
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                    SAPROPTERIN DIHYDROCHLORIDE

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                    9433624
                    2024-11-17
                    U-1589
                    205065
                    METHOD OF USE FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA
                    1
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                      7612073
                      2024-11-17
                      U-1010
                      205065
                      TO REDUCE BLOOD PHENYLALANINE LEVELS IN PATIENTS WITH HYPERPHENYLALANINEMIA DUE TO TETRA HYDROBIOPTERIN RESPONSIVE PHENYLKETONURIA. KUVAN SHOULD BE TA
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                        SAPROPTERIN DIHYDROCHLORIDE

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                        9433624
                        2024-11-17
                        U-1589
                        205065
                        METHOD OF USE FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA
                        2
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