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Re: Biopharm investor post# 74280

Wednesday, 03/11/2009 10:10:43 PM

Wednesday, March 11, 2009 10:10:43 PM

Post# of 257257
H-W arithmetic on effective exclusivity period for NCE’s:
 
4.0 yrs to earliest generic application (statutory NCE period less 1 yr)
+ 2.5 yrs (automatic stay on final FDA approval)
=========
6.5 yrs

+0.5 yrs if pediatric extension applies
=========
7.0 yrs total effective period of exclusivity

In other words, BIO and GPhA are still far apart, but not as far apart as the news reports make it seem.

p.s. I know you know all this, but some readers may not.


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