For patent information go to
I wouldn't expect a generic for at least a year after the patent expires in the US
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)
See 21 C.F.R. 314.108 New Drug Product Exclusivity.
Depends which catagory it falls into. It says the patent was registered 2004. I don't remember hearing about it till 2007 or 2008.
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