Regulatory Open Forum

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  • 1.  Proprietary name for Generic drug

    Posted 03-Nov-2012 12:03

    Dear friends,

    Can 1 ANDA be marketed under 2 brands??

    Can generics (other than Authorized generics) be marketed in the US as Branded generics with proprietary name other than innovator's. 

    Please clarify.
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    Ramesh 
    Panchakula
    India
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  • 2.  RE:Proprietary name for Generic drug

    Posted 03-Nov-2012 17:06
    Theoretically, a single ANDA can support more than one private label distributor, which could be called "branded" drugs. 

    And, yes, a drug approved under an ANDA may bear a proprietary name.  However, if it does, it implies that the product will be marketed more on its brand status than to depend on substitution due to being therapeutically equivalent.

    Best,
    Michael


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