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is there a generic alternative to cialis

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    In particular, the present invention relates to potent inhibitors of cyclic guanosine 3 ,5 -monophosphate specific phosphodiesterase type 5 (PDE5) that when incorporated into a pharmaceutical product at about 1 to about 20 mg unit dosage are useful for the treatment of sexual dysfunction.
    Related Exclusivities Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not.
    Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
    The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
    Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
    A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

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