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