KZA 0.00% 8.0¢ kazia therapeutics limited

From the FDA website.. 3. How long is exclusivity granted for?...

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    From the FDA website..

    3. How long is exclusivity granted for?
    It depends on what type of exclusivity is granted.
    Orphan Drug (ODE) - 7 years
    New Chemical (NCE)- 5 years
    "Other" Exclusivity - 3 years for a "change" if criteria are met
    Pediatric Exclusivity (PED) - 6 months added to existing Patents/Exclusivity
    Patent Challenge – (PC) – 180 days (this exclusivity is for ANDAs only)


    An extra 2 years = 30% more revenue
    Last edited by primaus72: 22/04/15
 
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