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(11)    Patent No :    AP 2764    (73) Applicant(s)       
(21)    Application No :    AP/P/2007/004089    MYLAN LABORATORIES, INC., 781 Chestnut Ridge Road,       
            Morgantown, WV 26504,       
                   
(22)    Filing Date :    30.01.2006    United States of America       
(24)    Date of Grant &    23.09.2013           
                   
(45)    Publication :

(30)  Priority Data    (72) Inventors

    (33) Country    (31) Number    (32) Date    DUNCAN Joseph, United States of America   
    US            60/648,551        31.01.2005    O'DONNELL John P, United States of America   
    US            60/755,856        03.01.2006       
                            OWENS Walter, United States of America   
                                   
                                et al       
                                (74) Representative   
(84)    Designated State                   
                           
    BW    GM    GH    KE    LS    MW    MZ   NA   SL    GALLOWAY & COMPANY   
    SD    SZ    T Z    UG    ZM    ZW        ZIMBABWE       
                                       
(51)    International    Classification    C07D 311/58 (2006.01)    A61K 31/353 (2006.01)   
                            A61P 9/00 (2006.01)    A61P 9/08 (2006.01
(54)    Title

Hydroxylated nebivolol metabolites

(57)    Abstract

Hydroxylated nebivolol metabolites increase NO release from human endothelial cell preparations in concentration dependent fashion following acute administration. In addition, hydroxylated nebivolol metabolites, including butt not limited to 4-hydroxy- 6.6'difluoro-,

4-hydroxy-5-phenol-6,6'difluro-, and 4-hydroxy-8-pheno-6,6'difluro -,have the ability to increase the capacity for NO release in human endothelial cells following chronic administration. This invention provides hydroxylated nebivolol metabolites and compositions comprising nebivolol and/or at least one hydroxylated metabolite of nebivolol and/or at least one additional compound used to treat cardiovascular diseases or a pharmaceutically acceptable salt thereof, In addition, this invent ion provides methods of treating and/or preventing vascular diseases by administering at least one hydroxylated metabolite of nebivol that is capable of releasing a therapeutically effective amount of nitric oxide to a targeted site affected by the vascularr disease. Also this invention is directed to the treatment and/or prevention of migraine headaches administering at least one hydroxylated metabolites of nebivolol. This invention may also be used in conjunction with or as a single treatment metabolic syndrome disorders.

(56)    Documents Cited :    VAN PEER A et al    EP 0 334 429    COCKCROFT J    HENDRICKX J et al    MCNEELY W et

al

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